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Abstract of thesis entitled
“An evidence-based pelvic floor muscle training program to reduce urinary
incontinence for patients undergoing transurethral resection of prostate”
Submitted by
Leung Pui Ngan Connie
for the degree of Master of Nursing
at The University of Hong Kong
in July 2014
Transurethral resection of prostate is a golden standard treatment for benign
prostate hypertrophy. However, urinary incontinence is a common phenomenon
of patients after operation. It gives great impact to their quality of life. With the
development evidence-based practice in nursing, nurse translates the best
evidence into practice to reduce urinary incontinence for patients undergoing
transurethral resection of prostate.
Pelvic floor muscle training is a safe and a conservation treatment to reduce
urinary incontinence for patients undergoing operation. It reduces the social and
health burden as well as to promote the development of professional nursing care
in Hong Kong.
This thesis is to develop an evidence-based guideline for patients to practice
pelvic floor muscle training to reduce urinary incontinence undergoing the
transurethral resection of prostate. Systematic literature search were performed
to extract valid articles, finally six articles were selected. Scottish Intercollegiate
Guidelines Network (SIGN) checklist was applied to assess quality of each
study.
The target audiences of the pelvic floor muscle training program are
patients planned to have elective transurethral resection of prostate at least two
weeks before operation. It is proposed to implement in a day and a urology wards
of an acute hospital.
The high implementation potential of the program is estimated after
examination of the local transferability, feasibility and cost-benefit ratio. An
evidence-based practice guideline is developed to deliver the best quality of
nursing care to patients undergoing transurethral resection of prostate. To
facilitate implementation of the program, a tailor-made pilot study with
implementation and evaluation plans are elaborated.
An evidence-based pelvic floor muscle training program to reduce urinary
incontinence for patients undergoing transurethral resection of prostate
by
Leung Pui Ngan Connie
RN, RNM, BSc (Nursing), MSc (AIM)
A thesis submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong
July 2014
i
Declaration
I declare that this thesis represent my own work, except where due
acknowledgement is made, and that is has not been previously included in a
thesis, dissertation or report submitted to this University or to any other
institution for a degree, diploma or other qualification.
Signed …………………………………………………………………….
Leung Pui Ngan Connie
ii
Acknowledgements
I would like to thank my supervision, Dr. Denise Chow, who gave me
guidance and support in this thesis. Her generous assistance enabled me to
complete the thesis.
Also, I would like to express my gratefulness to my classmates, who
support and encourage me to get through the difficult times throughout my
period of study.
Finally, I want to express my warmest gratitude to my husband and family
for their patience and support throughout these two years.
iii
Contents
Declaration ............................................................................................................ i
Acknowledgements ............................................................................................... ii
Contents .............................................................................................................. iii
Chapter 1
Introduction ......................................................................................................... 1
1.1 Background ..................................................................................................... 2
1.2 Affirming the Need ......................................................................................... 4
1.3 Research Question .......................................................................................... 6
1.4 Aims and Objectives ....................................................................................... 6
1.5 Significance of the Study ................................................................................ 7
Chapter 2
Critical Appraisal ................................................................................................ 9
2.1 Search Strategy ............................................................................................... 9
2.2 Appraisal Strategies ...................................................................................... 12
2.3 Results……………….. ................................................................................. 13
Chapter 3
Translation and Application ............................................................................. 31
3.1 Implementation Potential .............................................................................. 31
3.2 Transferability of the Findings ...................................................................... 33
3.3 Feasibility… ...................................................... ……………………………35
3.4 Cost-benefit Ratio of the innovation ............................................................. 37
3.5 Evidence-Based Practice Guideline .............................................................. 42
Chapter 4
Implementation Plan ........................................................................................ 51
4.1 Communication Plan ..................................................................................... 51
4.2 Pilot Study Plan ............................................................................................. 57
iv
4.3 Evaluation Plan ............................................................................................. 59
Chapter 5
Conclusion ......................................................................................................... 68
List of Appendices ............................................................................................. 70
Appendix 1: Search Strategies and Result .......................................................... 70
Appendix 2: Table of the Scottish Intercollegiate Guidelines Network (SIGN)
Grading System ............................................................................. 71
Appendix 3: Tables of Evidence ......................................................................... 72
Appendix 4: Methodology Checklists ................................................................ 81
Appendix 5: Summary of Levels of Evidence .................................................... 93
Appendix 6: Summary of Quality Assessment of the Selected Studies .............. 94
Appendix 7: Summary of the Data of the Selected Intervention Studies ........... 95
Appendix 8: Recommendation from Synthesis Process ..................................... 96
Appendix 9: Summary of Recommendation from Reviewed Studies ................ 99
Appendix 10: ICIQ-UI Short Form ................................................................... 101
Appendix 11: The Chinese Version of the ICIQ-UI Short Form ...................... 102
Appendix 12: Nurses’ Evaluation Form for Self-perceived Skills and
Knowledge and Satisfaction Level ............................................. 103
Appendix 13: A Permission Letter for the use of ICIQ-UI Short Form ............ 104
References ........................................................................................................ 105
1
Chapter 1
Introduction
Benign prostatic hypertrophy (BPH) is a non-malignant enlargement of the
prostate gland, commonly found in men over the age of 50 (Roehrborn &
McConnell, 2002). Currently, transurethral resection of prostate (TURP) is the
most common and a golden standard treatment for BPH (Paolone, 2010;
Rassweiler, et al., 2006; Sun, 2005). However, 0.6 - 40% of the patients suffered
from urinary incontinence after TURP (Lourenco et al., 2008; Rassweiler et al.,
2006). Urinary incontinence may have great impact on their quality of life and
imposed burden to the health care system. Pelvic floor muscle training (PFMT)
is a safe, feasible and conservation management for urinary incontinence after
TURP. With the professional nursing care, the social and health burden will be
greatly reduced. Although there are a lot of empirical evidences and clinical
practices supporting the PFMT in patients after prostactectomy (Bauer et al.,
2009), a guideline or protocol of PFMT for patients undergoing TURP in local
clinical setting is lacking. The purpose of this translational research is to translate
the best evidence into practice to prevent or reduce the urinary incontinence of
patients underwent TRUP by PFMT.
2
1.1 Background
Benign prostatic hypertrophy (BPH) is a non-malignant enlargement of the
prostate gland, one of the most commonly disease in men over the age of 50.
Prostate becomes larger in most men as they get older. Based on the several
autopsy studies, about 50 - 60% of men in their 60s, and 80 - 90% of men in their
70s and 80s with enlarged prostate (Roehrborn & McConnell, 2002).
In the 2011 Population Census, the life expectancy for men in Hong Kong
was 80 years. Of the 7.07 million populations in Hong Kong, 13.3% (438,257) of
men were 65 years old or above (Census and Statistics Department, 2012). In a
local community survey amongst men in age 40 - 79 in 2003, 16% of Hong Kong
men had moderate to severe lower urinary tract symptoms (Ngai, 2004).
Nowadays, there are different options to treat BPH such as conservative
methods, drug treatment. For moderate to severe lower urinary tract symptoms
secondary to benign prostate hyperplasia, surgical treatment must be considered
if the medical therapy is fail to response. In surgical treatment, TURP is a golden
standard for BPH givens its long-term efficacy established in clinical studies
3
(Paolone, 2010; Rassweiler et al., 2006; Sun, 2005). After successful surgery,
0.6% to 40% of patients may suffer from temporary urinary incontinence in early
post-operatively period (Lourenco et al., 2008; Rassweiler et al., 2006).
The International Continence Society defines urinary incontinence is a
storage symptom with the complaint of involuntary loss of urine (Abrams et al.,
2009). Urinary incontinence is a distressing condition that may have great
impact on patient’s quality of life. It associated with low self-esteem, social
anxiety and depression if persistent incontinence cannot be managed. An
unexpected increased societal cost in seeking health care services and increased
need for nursing home care will be anticipated (Glazener et al., 2011a).
Pelvic floor muscle training (PFMT) is a first-line conservative
management method for urinary incontinence (Harris, 1997). It is a safe,
non-invasive behavioural treatment. It is performed by repeated contraction and
relaxing the pubococcygnus muscles of the pelvic floor to increase its
contractility of the distal urethral sphincter. PFMT is a recommended first-line
treatment for early incontinence that follows prostatectomy within the first 6-12
months (Bauer et al., 2009).
4
1.2 Affirming the Need
In view of the ageing population and increasing life expectancy men in
Hong Kong, urinary incontinence related to the post TURP will be increasing in
future. Currently, TURP is a standard golden operation for BPH; 2365 TURP
were done in Hospital Authority hospitals in Hong Kong in the year of 2010
(Man, 2011). Since the urinary incontinence is usually temporary and it is not a
life-threatening issue after TURP, the prevalence is not well reported in clinical
practice. Also, the outcomes of medical and surgical treatments are usually
evaluated in long-term observation (Willener, Spichiger & Hantikainen, 2008).
I am currently working in a urology ward of a public hospital in Hong Kong.
TURP is the most common operation in a urology ward. By the retrospective
clinical observation from September 2012 to August 2013, there were 15 patients
underwent TURP per month. According to the above studies, 0.6% to 40% of
patients with urinary incontinence after TURP, then 0.1 to 6 patients per month
will suffer from it. Also, nurses received telephone enquiry of average 4 patients
per month about various degree of urinary incontinence after TURP by
retrospective clinical record from July to August 2013. This prevalence presents
5
a substantial health concern in my working area.
A preliminary search of the available evidences on management measures
for urinary incontinence after TURP was carried out. The measures include
supervised PFMT, drug therapy and surgical intervention (Heath & Watson,
2002; Miller & Miller, 2011; Thuroff et al., 2011). In clinical practice, we can
provide PFMT before operation and remind patients to do it after discharge to
help them to regain continence earlier.
Nowadays, there is still lacking of standardization of the most effective
PFMT protocol. There are conflicting evidences in using biofeedback or
electrical stimulation together with PFMT. Also, the identification of the
initiation time for PFMT either before or after operation is needed. The content,
frequency and duration of the PFMT is also being identified. There is a strong
need to conduct an extensive review of well-designed studies to evaluate the
different types of interventions and to develop an evidence-based PFMT
program for patients after TURP in local clinical setting.
Urinary incontinence may have great impact on quality of life of patients. It
6
must be anticipated earlier to prevent any social isolation or depression of
patients. Nurses must play a vital role to promote earlier recovery of patients by
attending physical, psycho-social needs of patients. It will greatly reduce the
health care and social burden.
1.3 Research Question
From the above discussion of the background and the need of the
evidence-based practice on this topic, the research question of this study is “In
patients underwent transurethral resection of prostate, how does the pelvic floor
muscle training compare to without training affect the post-operative urinary
incontinence?”
1.4 Aims and Objectives
The aim of this study is to develop an evidence-based pelvic floor muscle
training program to reduce urinary incontinence for patients undergoing
transurethral resection of prostate.
The objectives of this study are:
(1) To review the current literatures systematically for the effectiveness of the
PFMT for urinary incontinence after TURP;
7
(2) To extract data from the selected studies and compile it into the table of
evidence;
(3) To perform quality assessment of the selected studies;
(4) To identify the best evidence, feasibility and transferability of the PFMT to
the target patients in local setting.
(5) To develop an evidence-based practice protocol for quality care of patients
undergoing TURP in reducing severity and duration of the urinary
incontinence.
1.5 Significance of the Study
Urinary incontinence is a distress commonly after TURP. It threatens
patients’ quality of life and result of social anxiety and isolation. It is worthy to
build an evidence-based pelvic floor muscle training protocol which will benefit
to the patients, health care professionals and the hospital.
For patient, by practicing the PFMT, they can regain urinary continence
earlier and improve quality of life without taking any medication and operation.
It greatly improves their physical and psycho-social well beings. Also, it can
reduce their expenses and trouble in using incontinence pads.
8
For nurses, provide an evidence-based pelvic floor muscle exercises
program to patient undergoing TURP is a health care concern. Through the
program development and implementation, nurses can gain more autonomy and
confidence in nurse led education program as well as the evidence-based
protocol. PFMT is a non-invasive nursing intervention; it is the best opportunity
for nurses to develop their role in their profession.
For health care organization, health care professionals provide safe
evidence-based practice can build her reputation and reduce the financial burden
as well as the social burden to handle the complaints of urinary incontinence
from patients.
9
Chapter 2
Critical Appraisal
After formulated the research question, aims and objectives of the study;
and affirming the need and significance of developing an evidence-based pelvic
floor muscle training program in the local clinical setting, this chapter is going to
discuss the searching and appraisal strategies to identify the best evidence to
support the development of the new guideline.
2.1 Search Strategy
2.1.1 Selection criteria
Inclusion criteria
For the participants, men with BPH, who have undergone a TURP and have
PFMT intervention by health care professionals. The PFMT with and without
biofeedback, electrotherapy, and behavioural therapy are included. They must be
cognitive intact and able to understand the instructions. There is no limitation in
age, continence status and dependence on activity level.
For the types of studies, this review considered randomized controlled trials
(RCT) those report the incidence of doing PFMT before and after TURP. For the
10
outcome measures, the primary outcomes are the incidence of urinary
incontinence and urinary symptoms; the secondary outcomes are the quality of
life and the strength of pelvic floor muscle.
Exclusion criteria
Men were planned or receiving bradytherapy, with urethral or pelvic
surgery, suffering from neurological diseases or cognitive impairment.
2.1.2 Keywords
The keywords for searching were “prostate”, “urinary incontinence”,
“pelvic floor”, “transurethral resection of prostate”, “benign prostate hyperplasia”
and “pelvic floor muscle exercise”.
2.1.3 Search methodology
A search of literature was conducted on 18 August 2013, a systematic
four-step searching were utilized in this study. An initial search from the above
keywords via CINAHL Plus, PubMed, Science Direct and British Nursing Index
databases was done. Keywords and various combinations of them were used. All
the searches were limited the inclusion and exclusion criteria; and published on
11
or after January 1993. There was no language limitation. From the CINAHL Plus
database, only one study was yielded. In PubMed database, 17 studies were
yielded. In Science Direct, 112 studies were yielded. In British Nursing Index, 8
studies were yielded.
A second search, analysis of content in the title and abstract against
inclusive and exclusive criteria were done. One study from the CINAHL Plus, 6
out of 17 studies from PubMed, 2 out of 112 studies from Science Direct and 2
out of 8 studies from British Nursing Index were selected. After reading the
content of the studies, two studies were duplicated (Glazener, et al., 2011a &
2011b) and one study was eliminated due to it only involved one subject
underwent TURP (Joseph, 2000). Then, 6 randomized controlled trials were
selected from these databases searching.
Thirdly, clinical guideline searching was performed in the Scottish
Intercollegiate Guideline Network (SIGN), National Guideline Clearinghouse
(NGC), and American Urological Association (AUA) Guidelines, National
Institute for Clinical Excellence (NICE) and European Association of Urology
(EAU) guideline. However, neither was specific in management of the urinary
12
incontinence after TURP. Fourthly, the reference list of all related articles were
screened with no more additional article was found.
Finally, six randomized controlled trials (RCT) in English were selected in
this review. The table of search strategy and result in these databases was shown
in Appendix 1.
2.2 Appraisal Strategies
Data of the above selected six studies were extracted and recorded in form
of a table of evidence. An evidence table for intervention studies by the Scottish
Intercollegiate Guidelines Network (SIGN) was used. It included data on
bibliographic citation, study design and level of evidence, subject characteristics,
number of participants, dropout rate, intervention, comparison, data collection
time, outcome measures and effect size. Level of evidence of each study was
graded according to the SIGN (2013a) grading system which was shown in
Appendix 2.
For quality assessment of the selected six studies, a methodology checklist
for randomized controlled trials of SIGN (2013b) was used to guide the
13
assessment. The tables of evidence and methodology checklists of six studies
were shown in Appendix 3 and 4 respectively.
2.3 Results
After a systematic four-step searching of literature conducted on 18 August
2013, six studies were selected. Five studies were RCTs (Glazener et al., 2011a;
Hou et al., 2013; Ip, 2004; Porru et al., 2001; Tibaek et al., 2007) and one was
controlled trial (Chang et al. 1998). All were in English and published between
1998 and 2013. Data of all studies were extracted and illustrated in the form of
table of evidence according to the SIGN 50: a guideline developer’s handbook
(SIGN, 2013a). The table of evidence of each intervention study was showed in
Appendix 3.
2.3.1 Summary of levels of evidence
The levels of evidence of the six selected studies ranged from 1++ to 2++.
For the five randomized controlled trials, the level of evidence of Glazener et al.
(2011a) was 1++, Porru et al. (2001) and Tibaek et al. (2007) were 1+, Hou et al.
(2013) and Ip (2004) were 1-. For the controlled trial, the level of evidence was
2++ (Chang et al., 1998). Summary of levels of evidence of selected studies was
14
shown in Appendix 5.
2.3.2 Summary of quality assessment
The critical appraisal checklist of Scottish Intercollegiate Guidelines
Network (SIGN, 2013b) - “methodology checklist 2: controlled trials” was used
to assess quality of the six selected studies (Chang et al., 1998; Glazener et al.,
2011a; Hou et al., 2013; Ip, 2004; Porru et al., 2001; Tibaek et al., 2007).
Individual checklist for each study was shown in Appendix 4. Finally, a table of
the summary of quality assessment of the selected studies was shown in
Appendix 6.
All selected six studies addressed clearly and appropriately on focused
research question and provided details of the intervention and comparison
groups, and the measured outcomes for their research objectives.
Five selected trials were randomized controlled trails. Only two trials
included an adequate method of random group allocation and described
allocation concealment. Remote computer randomization and allocation was
described in Glazener et al. (2011a). Randomization by grouping in blocks of ten
15
of a mathematical table, and sealed in envelops by independent third party was
mentioned in Tibaek et al. (2007). Chang et al. (1998) allocated the groups by
preceding and subsequent men without randomization, this study should be a
controlled trial.
Most of the trials were not describe blinding. Due to the nature of the
intervention, blinding of the therapists, assessors and patients were not possible,
the risk of bias was not counted. However, three trials had made effort to
minimize bias by getting data entry. In Glazener et al., (2011a), data was entered
by clerks blinded to group. In Tibaek et al. (2007) and Porru et al. (2001), an
independent physiotherapist or urologist did initial and outcome pelvic floor
assessment respectively.
There were no significant between groups difference in baseline in all trials
except the one trial (Ip, 2004). It did not mention any demographic data of
subjects in both groups; it mentioned the incontinence state and score only.
For the equality of treatment and control groups being investigated, all
groups were investigated equally in all studies. For the outcome measures, all
16
relevant outcomes were measured in a standard and reliable way in all selected
studies except the one study (Ip, 2004). Her outcomes were not presented in a
statistically measures.
All studies reported the acceptable dropout rate; they ranged from 0% to
15.52%. All of them gave explanation or reasons of any withdrawals or dropouts.
Intention to treat analysis was applied in all studies except two studies with zero
dropout rates (Chang et al., 1998; Ip, 2004).
All studies were carried in one site only except a study by Glazener et al.
(2011a). Subjects were recruited from 34 UK centers, confidence of the result
was increased and comparable for all sites.
The overall methodological quality of the studies to minimize bias ranged
from low quality to high quality. Two studies (Glazener et al., 2011a and Tibaek
et al. 2007) were high quality with little or no risk of bias. Three studies (Chang
et al., 1998; Hou et al. 2013 and Porru et al. 2001) were acceptable quality with
associated risk of bias in missed criteria. One study (Ip, 2004) was low quality. It
might be the study was terminated prematurely due to change of clinical
17
operation.
2.3.3 Summary and synthesis of data
(1) Study characteristics
For the locations of the studies, two were conducted in Taiwan (Chang et al.,
1998; Hou et al., 2013). Other studies were conducted in different countries,
United Kingdom (Glazener et al., 2011a), Australia (Ip, 2004), Italy (Porru et al.,
2001) and Denmark (Tibaek et al., 2007).
For the sample size of the intervention studies, four medium trials of
subjects ranged from 50-66 (Chang et al., 1998; Hou et al., 2013; Porru et al.,
2001; Tibaek et al., 2007); one large trial of 442 subjects in 34 UK centers
(Glazener et al., 2011a) and one small trial of 16 subjects (Ip, 2004). Total 640
subjects participated in these studies.
For the subject characteristics, all trials included patients underwent TURP
who aged between 45 and 79 and did not undergo bradytherapy. In Glazener et al.
(2011a), it consisted of two studies, one was men with radical prostatectomy, and
another was men with transurethral resection of prostate. In this thesis, the study
18
of TURP in Glazener et al. (2011a) was considered. Five studies included men
without urinary catheter after operation (Chang et al., 1998; Glazener et al., 2011;
Hou et al., 2013; Porru et al., 2001; Tibaek et al., 2007) while one included men
with urinary catheter after operation (Ip, 2004).
For study purpose, all studies investigated the effectiveness of the PFMT
intervention. In addition of it, one study compared the effectiveness of
intervention between a visual reminder, refrigerator magnet, and a paper
reminder in PFMT (Ip, 2004); another one study investigated the use of Short
Form-36 Health Survey scale (SF-36) to assess the effect of PFMT (Hou et al.
2013); one study investigated the cost-effectiveness of one to one intensive
PFMT as well (Glazener et al., 2011a).
For comparison, four studies continued usual activity without any PFMT
was taught in control groups (Chang et al., 1998; Glazener et al., 2011a; Hou et
al., 2013; Porru et al., 2001); one study provided information and verbal
instruction of PFMT only after operation , without any individual or group
teaching of PFMT program in control group (Tibaek et al., 2007). A study
provided same PFMT information to both intervention and control groups, but in
19
different form with the magnet and paper reminder to the respective groups (Ip,
2004).
For the dropout rates of the selected trials ranged from 0% to 15.52%. Four
studies dropout rates were below 10% (Chang et al., 1998; Hou et al., 2013; Ip,
2004; Porru et al., 2001) whereas two studies were 10% to 15.52% (Glazener et
al., 2011a; Tibaek et al., 2007).
(2) Assessment and outcome measures
In the assessment and outcome measures, there was a lack of consistency in
the selected studies. A summary of the results was shown in Appendix 7. For the
primary outcomes, they included the urinary incontinence status and lower
urinary tract symptoms. Two trials with evidence levels 1+ and 2++ for men
post-TURP showed significant improvement in urinary incontinence after 4
weeks of PFMT (Chang et al., 1998; Porru et al., 2001). Only one trial with
evidence level 2++ (Chang et. al., 1998) for terminal dribbling, it was
significant improved after PFMT for 4 weeks. Three trials with evidence levels
ranged from 1+ to 2++ showed significant improvements in urinary symptoms
in objective uroflowmetry parameter - maximum urinary flow rate (Q max), and
20
total and storage score of International Prostate Symptom Score (IPSS), and
improvement of voiding interval in voiding diaries recording (Chang et al.,
1998; Hou et al., 2013; Porru et al., 2001).
In Ip (2004), no significant different in incident of urinary incontinence
might be due to small subject size and premature call off of study because of
operation changes. In Glazener et al. (2011a), evidence level 1++, the
International Consultation on Incontinence Questionnaire Urinary Incontinence,
short form (ICIQ-UI SF) was used for screening of the urinary incontinence
status of patients. It showed no significant different because the subjects were
recruited after six weeks after operation and first data collection period at three
months after operation. Reviewed from the significant results from other
studies, most of the significant different in incontinent status and urinary
symptoms occurred in about four weeks after training or operation. Also, the
high rates (64.9% of intervention group and 61.6% of control group) of
persistent incontinence after 12 months suggested of unrecognized
complication after operation. According to the National Guideline
Clearinghouse (2009), further investigation and treatment were suggested for
patients failed after 6-12 months of first-line conservation management by
21
PFMT.
For secondary outcomes of pelvic floor muscle strength and quality of life,
three trials with evidence levels ranged from 1+ to 2++ showed significant
strengthening of pelvic floor muscle by using digital anal grading with the
modified Oxford scale after 4 weeks (Chang et al., 1998; Porru et al., 2001;
Tibaek et al., 2007). Another two trials did not assess pelvic floor muscle
strength (Hou et al., 2013; Ip, 2004).
In Glazener et al. (2011a), there was no significant different in the pelvic
floor muscle strength was found compared with no PFMT group after 3 months
of PFMT. However, all subjects showed great fall of proportion with
incontinence from 82% to 52% after 3 months of intervention. It may show that
urinary incontinence is a temporary state after TURP. Meanwhile, the review of
this study commented the PFMT information was widely available in the
internet and study area, about 21% in both control and intervention group
subjects had practiced PFMT before randomization even though without formal
teaching by health care professionals. Also, the pelvic floor muscle strength was
measured in intervention groups only; statistically significant between groups
22
would not be determined.
For assessing the subjective impact on quality of life by urinary
incontinence in selected studies, they used different measuring tools without any
consensus. Four studies used three urinary symptoms measuring tools -
International Prostate Symptom Score (IPSS), American Urological Association
Symptom Index (AUA-SI) and Danish Prostatic Symptom Score (DAN-PASS-1)
because all three tools with a separate quality of life score in the questionnaire
(Chang et al., 1998; Hou et al., 2013; Porru et al., 2001; Tibaek, et al., 2007). No
study showed significant different in this area as they were not sensitive to the
urinary incontinence subjects.
Similarly, two studies used two incontinence tools ICIQ-UI SF and St.
George urinary incontinence score; there was one question about quality of life
(Glazener et al., 2011a; Ip, 2004). Finally, both studies did not show any
significant different result after intervention.
On the other hand, general health questionnaire with physical, mental,
psycho-social dimensions showed significant improvement after PFMT in 3
23
studies with evidence levels ranged from 1+ to 2++. The Short Form Health
Survey scale (SF-36) was used in Hou et al. (2013) showed significant
improvement in both physical and mental dimensions after 12 weeks of PFMT.
The Patient satisfaction score in Chang et al. (1998) showed significant
improvement in total score and psychological and social dimensions after 4
weeks of PFMT. The ICS male questionnaire showed significant improvement
after 4 weeks of PFMT (Porru et al., 2001). The European Quality of Life -5
Dimensions (EQ-5D) and Short form-12 health survey (SF-12) were used in
Glazener et al. (2011a), no significant was found at 6 and 12 months after
interventions. General health questionnaires were more sensitive for urinary
incontinence men in assessing their quality of life when compared to urinary
symptoms specific questionnaires. Similarly, two studies did not assess it (Ip,
2004; Tibaek et al., 2007).
In Glazener et al. (2011a), there was no significant difference in both types
of questionnaires in quality of life between the intervention and control groups.
However, the men showed a gradual improvement over time in their quality of
life as showed in the mean ICI-Q score and measures in their quality of life
dimensions in EQ-5D and SF-12 in 3, 6 and 12 months of reviews. It might hint
24
that men undergo gradual recovery from the operation.
For assessing the health economic outcomes by the incremental cost per
quality-adjusted life-year (QALYS) in a study of Glazener et al. (2011a), it
showed significant different between the intervention and control group after 12
months of intensive PFMT.
3. Interventions
In PFMT regime, all studies except one study (Ip, 2004) included an initial
individual assessment of pelvic floor muscle tone by digital anal examination as
Ip (2004) did not mention the mode of delivery of PFMT in details. Only one
individual session for PFMT in four studies showed more significant different
results in pelvic floor muscle strength, incidence of urinary incontinence,
urinary symptoms and general measures of quality of life (Chang et al., 1998;
Hou et al., 2013; Porru et al., 2001) compared to multiple individual or group
teaching sessions by therapists in two studies (Glazener et al., 2011a; Tibaek et
al., 2007). Four studies with evidence levels ranged from 1+ to 2++.
For initiation time of PFMT, men showed earlier significant regaining
25
continence in 1, 2, 3 weeks and significant lengthen voiding interval after 2 and 3
weeks operation in a pre-operative trial with evidence level 1+ (Porru et al.,
2001). In post-operative trials, men showed significant regaining continence
after practicing PFMT in 3 weeks onwards (Chang et al., 1998); men showed
significant improvement in urinary symptoms presented in IPSS in 4 weeks after
PFMT (Hou et al., 2013). That is, men will regain continence or improvement of
urinary symptoms by practicing PFMT earlier before operation.
In the pre-operative study of Tibaek et al. (2007), it showed no significant
different in pre and post-operative initiation of PFMT. It may be explained that
the only one teaching session before operation was not enough for elderly to
catch up the technique, and the exact duration before operation for intervention
was not mentioned in the study as it may greatly affect the recovery time after
PFMT.
For the PFMT content, there was no consensus in six selected studies. But
they exhibited several common characteristics. They must include daily home
practice, slow contraction in 3 positions, and the “knack”, tighten the pelvic
floor muscle strongly after voiding. PFMT with 1-6 times per day, 6-10 series of
26
3-15 slow contractions (evidence levels ranged from 1++ to 2++). After that,
patients’ motivation and compliance are the critical criteria for successful
outcome.
Biofeedback was used in two studies. One study was Glazener et al. (2011a),
evidence level 1++, only 13 of 220 men used biofeedback in this study; another
study was Hou et al. (2013), evidence level 1+, a surface electromyogram (EMG)
was applied to confirm patients doing correct PFMT, no measurement of pelvic
floor muscle strength was performed. In local setting, the use of biofeedback is
optional depends on its availability.
For the types of therapists, there was only one trial with evidence level 1++
for different disciplines of therapists’ comparison, physiotherapists and
continence nurses (Glazener et al., 2011a). It did not show any statistically
significant differences in the attendance of therapeutic sessions or mean
incontinence scores as both disciplines exhibited standard training in the study.
For education tools, all studies included the verbal or in addition of written
instructions for home exercise as they were the basic educational tools. In the
27
study of Ip (2004), evidence level 1-, used a refrigerator magnet as a visual
reminder for exercise to compare the paper copy, the result was inconclusive due
to small sample size from premature call off. However, the patients appreciated
it was a good idea for reminder.
For the bladder training and lifestyle leaflet in addition of PFMT, they were
suggested in two trials (Glazener et al., 2011a; Ip, 2004). But they were not
investigated in these two studies.
4. Period of follow-up sessions and data collection methods
All studies collected data at baseline and intermittent periods after
interventions. Teaching classes, clinical visits, telephone follow up, or postal
questionnaire were used to monitor and record patients’ progress and their
compliance. The duration ranged from weekly in first four weeks and up to 12
months. After reviewing the selected studies, follow-up or data collection in
four weeks and 12 weeks got the most significant different results.
2.3.4. Recommendations
After the critical review of the evidence, benefits of PFMT and incidence of
28
regaining urinary continence was demonstrated in some selected studies, it was
helpful to draw out recommendations. Appendix 8 showed tables of
recommendation from synthesis process.
(1) Target group will be men with BPH and had undergone TURP. They were not
planned or received bradytherapy. They did not have urethral or pelvic
surgery; and not suffering from neurological diseases or cognitive
impairment. They can be communicated and understood the therapists’
instruction for PFMT.
(2) Assessment and outcome measures
The ICI-UI SF and voiding diary were recommended assessment tools
for urinary incontinence. The AUA-SI and IPSS were similar in meaning with
the identical grading method, either one of them was recommended to use in
assessing severity of urinary symptoms. Voiding and storage parameters by
uroflowmetry and bladder scan were suggested to quantity the severity of
urinary symptoms and to monitor patients’ progress of treatment. Modified
Oxford Scale was recommended to assess the pelvic floor muscle strength. For
generic health assessment, physical, psycho-social and emotional dimensions
29
were recommended. A commonly used, well-validated with a Chinese version
of questionnaire is the major chosen criteria for the local study.
(3) Intervention
An individual baseline assessment and teaching session was
recommended. PFMT was suggested to start as soon as possible before
surgery to help patients regain continence earlier. In regime of PFMT,
strong contractions in lying, sitting and standing positions, the “knack” and
tightening the pelvic floor muscles strongly after voiding were
recommended. Nurses with specialized experience in incontinence will be
recommended as therapist as they will follow-up patients from
pre-operative to post-operative and provide an integrated care planning and
related home advice to patients as a whole. Verbal and written instructions
for home exercise, a visual reminder such as a refrigerator magnet was
recommended to increase PFMT compliance. In addition of PFMT, bladder
training and lifestyle leaflet were suggested.
(4) Duration and mode of follow up sessions
Follow up at 2, 4 and 12 weeks after operation or discharge was
30
suggested to monitor their progress and to increase their compliance of
PFMT. In local setting, the duration and mode of follow-up will greatly
depend on the availability of the manpower and budget. Multiple teaching
follow up sessions can be applied to the setting with the information of
PFMT is not widely available in the society or targeted to special age group
- elderly. Elders are not easily catch up the technique of contractions
without professional health care instruction.
31
Chapter 3
Translation and Application
After reviewed and identified the best practices, this chapter is going to
discuss the implantation potential, transferability of the findings and feasibility
of the reviewed studies in local clinical setting. Then, an evidence-based practice
guideline of pelvic floor muscle training program is introduced.
3.1 Implementation Potential
The proposed program is the pelvic floor muscle training (PFMT) program
to reduce urinary incontinence for patients undergoing transurethral resection of
prostate (TURP). In the above review, it is shown that the PFMT program can
reduce urinary incontinence and increase quality of life in men after TURP. This
effective program is proposed to be translated into local practice. Before
implementation, the target setting and audience, the transferability of the
findings, feasibility and cost-benefit ratio of the proposed program will be
examined.
32
3.1.1 Target setting
The proposed pilot PFMT program will be implemented in a 42 beds
urology in-patient ward and a 31 beds day ward in an acute hospital under the
Hospital Authority.
3.1.2 Target audience
The target audiences of the innovation are all patients who are scheduled for
elective TURP within at least one week before operation and have pre-operative
assessment (PAS) in day ward as they will have sufficient time for exercise
education and practicing at home before operation. They must be mentally-fit
and capable of independent daily living activities as they must have the ability to
learn and practice the exercise. There is no limitation of age. All participants
fulfill the selection criteria and give the consent to the pilot program.
The exclusion criteria are men planned or receiving bradytherapy, with
urethral or pelvic surgery, suffering from any neurological or cognitive
impairment.
33
3.2 Transferability of the Findings
Transferability refers to whether the selected research findings can fit into
the local clinical practice. It is explored as below.
3.2.1 Setting
The target setting of innovation and reviewed studies are done in hospital.
In the reviewed studies, the training program was supervised by nurses or
physiotherapists. Similarly, the proposed program will be implemented by
nurses working in the urology and day wards. Two Advanced Practice Nurses
(APN) – urology nurses, who are qualified from urology training, will be
responsible for implementation of the proposed program before and after
operation.
3.2.1 Characteristics of patients
Characteristics of the target audience match greatly with the participants in
all reviewed studies in which they were men, aged between 45 and 79, who were
undergoing TURP. Most of them were elderly because of the etiology of the
disease. The participants in the review studies were predominantly Caucasians
but two reviewed studies were conducted in Chinese population (Chang et al.,
34
1998; Hou et al., 2013). Since the studies in Chinese population also obtained
significant positive outcomes, cultural difference may seemingly not a huge
concern.
3.2.3 Philosophy of care
The innovation and the review studies are congruent in philosophy of care.
They aim to help patients to reduce urinary incontinence or regain urinary
continence, and increase their quality of life ultimately. Similarly, the mission of
the target setting is to excel in the provision of holistic patient-centered quality
care to help people stay healthy (Hospital Authority, 2013a).
3.2.4 Sufficiency of clients benefit from the innovation
According to the retrospective clinical observation from September 2012 to
August 2013, there were 11 of 15 patients underwent elective TURP with the
PAS per month. There will be 66 patients benefited in the 6 month - pilot training
program.
3.2.5 Time schedule for implementation and evaluation
During the implementation of the program, nurses in urology and day wards
35
are the main conductors of PFMT for men undergoing TURP. Urology nurses in
day ward will provide pre-operative PFMT when patient having urine and blood
investigations at least two weeks before operation. Then nurses will review
patients about one week before operation when they admit to day ward for PAS.
After operation, nurses in urology ward will reinforce them to practice PFMT on
discharge and arrange urology nurses’ follow-up. Two interview sessions before
operation and one session on discharge have to help patients especially elderly to
catch up the PFMT technique and increase their compliance. Then patient will
follow up at 4th
and 12th
week after operation, which is similar to the majority of
the selected studies.
3.3 Feasibility
Feasibility of the innovation is more practical concerns which may involve
the organization climate, availability of manpower and resources in clinical
setting. Patients have right to terminate the program when it is considered
undesirable.
3.3.1 Interference on current staff functions
Incorporation of the proposed program into the services of the TURP
36
patients, the time and workload of interviewing and assessment are expected to
increase. However, PFMT will decrease the number of telephone enquiry and
medical consultation relate to urinary incontinence after TURP.
From the above estimation, only 11 target patients will join per month. The
risk of conflict among nurses is low as it will not significantly increase their
workload to provide an individual 30 minutes training session in their first
attendances. Then, nurses only need to remind the steps and importance of
practice with the help of refrigerator magnet in the follow-up sessions which may
spend about 15 minutes in each follow-up session. Currently, nurses are
providing PFMT to patients with radical prostatectomy; it will not greatly
interfere on current staff functions.
3.3.2 Administration and resources support
Administration support is important for the success of the innovation. The
key is to communicate with urologists and gaining their support for the innovation
because its low cost and high benefit with the minimal risk to the patients.
Since nurses work in urology and day wards are providing PFMT education
37
to patients with radical prostatectomy, urology nurses will conduct two identical
one hour-briefing sessions introduce this training and evaluation program.
There is no special equipment is required for the program. An information
leaflet and a refrigerator magnet will be given to the patient. Measuring tools for
outcome evaluation are commonly available. The PFMT will be carried in a
consultation room in day ward and an interview room in urology ward. Patients
will follow-up in the urology nurse clinic to evaluate their outcomes. All of the
facilities are currently available.
3.4 Cost-benefit Ratio of the innovation
The cost-benefit ratio of the proposed program must be assessed before the
implementation.
3.4.1 Potential risks and benefits of the innovation
The potential risk expose to patients is minimal. PFMT is a safe, first
conservation management for patient with urinary incontinence after TURP
(Harris, 1997; Bauer et al., 2009). Meanwhile, all patients will enroll in the
innovation program after assessment from the doctors and nurses in order to
38
minimize the potential risk.
Patient will benefit from the innovation as they may reduce the risk of
urinary incontinence or regain continence earlier after TURP. Patients’ hospital
stay will shorten and reduce their complications related urinary incontinence.
They will achieve better quality of life.
3.4.2 Disadvantage of maintaining current practice
At present, some nurses and doctors advice patients to perform PFMT when
they had urinary incontinence after TURP. Patients are suffering from a period of
urinary incontinence as PFMT needs to take a period of time to be effective. It
greatly worsens their quality of life even after operation.
Also, we only provide a brief PFMT by means of verbal and written
instruction only. Learning the right technique and practicing at home are two key
elements in PFMT. Majority of patients for TURP are elderly, they require more
instructions, demonstration and encouragement in learning new things.
Otherwise, they will abandon the exercise and suffer from urinary incontinence.
They become social isolated and depressed.
39
3.4.3 Material costs of implementing the innovation
The majority of the budget will be spent on the salary of the nurses. There
are four contact times between patients and nurses during the program. In the
first contact time will be 30 minutes, the following 3 contacts will spend about 15
minutes each time. Totally nurses will spend about 75 minutes to each patient.
The urology nurses will attend patients in first and last visits.
According to the Master Pay Scale (Civil Service Bureau, 2013), the mean
monthly salary with allowances of a Registered nurse (RN) is HK$36,348 and an
APN is HK$57,662. They are working for 190 hours per month. The total cost is
calculated as follows:
Mean salary of a RN is HK$3.19 per minute (HK$36,348 ÷190 ÷ 60 =
HK$3.19/ minute).
Mean salary of an APN is HK$5.06 per minute (HK$57,662 ÷ 190 ÷ 60 =
HK$5.06/ minute).
Cost for nursing manpower for one patient is HK$323.40 (HK$3.19 x 30
minutes + HK$5.06 x 45 minutes = HK$323.40).
40
Total cost for 6 months is HK$21,344.40 (HK$323.40 x 11 patients x 6
months = HK$21,344.40).
Other than that, the material costs are low because no additional equipment
is required to be purchased. The printing costs of information leaflets, consent
forms, questionnaires and assessment forms of the proposed program are low as
the printing service is available in the hospital. One hundred of refrigerator
magnets will be prepared due to the minimum order in the market; they only cost
about HK$300. It is estimated that for a short-term 6 months implementation of
the proposed program will cost about HK$21,644.40.
3.4.4 Material costs of not implementing the innovation
If the innovation is not implemented, patients will suffer from urinary
incontinence and seek medical service. An average health care service of a
patient is one day hospital stay and three times of out-patient follow-up. The
estimated cost of one day acute care hospital stay is HK$4,680 and one
attendance at a specialist clinic is HK$1,110 (Hospital Authority, 2013b). The
minimum cost for 6 months will be: [HK$4,680 + (HK$1,110 x 3 times)] x 11
patients x 6 months = HK$528,660. Meanwhile, medication for urinary
41
incontinence and the loss of hospital reputation were uncountable cost.
3.4.5 Potential non-material costs and benefits of implementing the
innovation
The potential non-material costs will be increased nurses’ workload and
stress in learning and adapting the proposed program. It is an extended service
from patients with radical prostatectomy to TURP. If the innovation comes with
a good communication plan with adequate training and information provided to
nurses before implementation can greatly reduce their stress.
Meanwhile, it gains better nurse-patient trusting relationship with
appreciation from patients due to better commitment and quality of care. For
hospital, it may reduce the rate of telephone enquiry, clinical follow-up and
workload of health care professionals. For nurse professional, it may help to
increase nurse autonomy, morale and job satisfaction as it is a nurse-led service.
3.4.6 Cost-benefit ratio
The cost-benefit ratio is HK$21,644.40 / HK$528,660 = 0.04, and the
uncountable costs are not included. As the cost-benefit ratio is less than 1, this
42
innovation is worth to implement.
In conclusion, the innovation can be implemented because of its
transferability, feasibility and cost-effectiveness.
3.5 Evidence-Based Practice Guideline
After affirming the potential of implementing this innovation, an
evidence-based guideline is developed based on the selected studies in the
previous section.
3.5.1. Title of the guideline
The title is “An evidence-based pelvic floor muscle training program to
reduce urinary incontinence for patients undergoing transurethral resection of
prostate”.
3.5.2. Aim and objectives of the guideline
The aim of the guideline is to provide an evidence-based pelvic floor
muscle training program to nurses to reduce urinary incontinence for patients
undergoing TURP.
43
The objectives are:
(1) To formulate clinical practice instructions for the patient to regain urinary
continence after TURP based on the best evidence available;
(2) To reduce the complications related to post-operative urinary incontinence
by practicing PFMT;
(3) To standardize the PFMT process of patient undergoing TURP.
3.5.3. Target group
The target participants of the innovation are men who are scheduled for
elective TURP within at least one week before operation and have PAS in day
ward to ensure they have sufficient time for exercise education and practicing at
home before operation. They must be mentally-fit and capable of independent
daily living activities. The exclusion criteria are men planned or receiving
bradytherapy, with urethral or pelvic surgery, suffering from any neurological or
cognitive impairment.
3.5.4. Recommendations
The SIGN (2013a) grading system (Appendix 2) will be used to grade the
44
recommendation as follow:
Recommendations are divided into four parts:
(1) Assessment and outcome measurements
(2) Pelvic floor muscle training instruction
(3) Patient education tools
(4) Frequency of follow-up sessions
(1) Assessment and outcome measurements
Recommendation 1.1: Baseline assessment on urinary incontinence and urinary
symptoms should be performed before TURP. (Grade A)
Patients undergoing TURP may worsen their urinary symptoms and become
urinary incontinence. All the reviewed studies performed baseline assessment to
measure the progress of the urinary symptoms and degree of urinary
incontinence, four studies showed improved urinary or incontinence status
(Chang et al., 1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013 (1-);
Porru et al., 2001 (1+)).
45
Recommendation 1.2: Baseline assessment on the strength of pelvic floor muscle
should be performed before TURP. (Grade A)
Four of the six studies measured the pelvic floor muscle strength by
Modified Oxford scale to monitor progress of treatment. Three studies showed
improved muscle strength after 4 weeks PFMT (Chang et al., 1998 (2++); Porru
et al., 2001 (1+); Tibaek et al., 2007 (1+)).
Recommendation 1.3: General health questionnaires which consist of physical,
psycho-social and emotional dimensions are suggested for assessment the
impact of quality of life related to urinary incontinence. (Grade A)
General health questionnaires which consist of physical, psycho-social and
emotional dimensions were more sensitive in measuring the impact of quality of
life related to urinary incontinence. In Chang et al. (1998) (2++), the total,
psycho and social patient satisfaction scores were improved after PFMT. In Hou
et al. (2013) (1-), both the physical and mental dimensions in the Short Form
Health Survey scale (SF-36) showed improvement after PFMT. In Porru et al.
(2001) (1+), the ICS male questionnaire showed improvement after PFMT. Then,
46
a commonly used, well-validated with a Chinese version of general health
questionnaire is recommended for local practice.
(2) Pelvic floor muscle training instruction
Recommendation 2.1: Conduct a first teaching session on PFMT by trained
health care professional individually. (Grade A)
First teaching session on PFMT should be conducted by trained health care
professionals individually to ensure patient understand and perform it correctly,
clarify any worries to increase their compliance rate (Chang et al., 1998 (2++);
Glazener, et al., 2011a (1++); Hou et al., 2013 (1-); Porru et al., 2001 (1+);
Tibaek et al., 2007 (1+)).
Recommendation 2.2: The strength of pelvic floor muscle contraction should be
assessed and taught by digital anal examination with verbal feedback. (Grade A)
Digital anal examination with verbal feedback is the key step in learning the
correct PFMT. It helps patients control the pelvic floor muscles while keeping
the abdominal muscle relaxed with positive feedback from nurses (Chang et al.,
47
1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013; Porru et al., 2001;
Tibaek et al., 2007).
Recommendation 2.3: Patients should be educated for PFMT as soon as before
TURP. (Grade A)
Patients showed regain urinary continence earlier and increase voiding
interval when practicing PFMT before TURP than those of practicing after
operation. In Porru et al. (2001) (1+) pre-operative PFMT study, patients showed
the earliest improvement of urinary incontinence in voiding diaries after first
week of operation. In post-operative PFMT studies, patients got improvement in
urinary symptoms after 3 weeks and 4 weeks of operation in Chang et al. (1998)
(2++) and Hou et al. (2013) (1-) studies respectively; patients regained urinary
continence at 3 months after PFMT in Glazener et al., (2011a) (1++) study.
Recommendation 2.4: Patients should practice PFMT in three positions with 1-6
times per days and the “knack” at home. (Grade A)
After reviewing of selected studies, there shared several common contents
48
irrespective of no standardized duration and frequent of contractions in PFMT
regime. They consisted of practicing slow contractions in lying, sitting and
standing positions for 1-6 times per day, 6-10 series of 3-15 slow contractions,
duration of each contraction was set up to a maximum of 10 seconds according to
patients’ muscle strength (Chang et al., 1998 (2++); Glazener et al., 2011a (1++);
Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007
(1+)).
Two studies included “knack” practice in PFMT to reduce the risk of urinary
incontinence in daily life (Glazener, et al., 2013 (1++); Tibaek et al., 2007 (1+)).
“Knack”, tighten the pelvic floor muscle strongly before and during any event
which might cause leaking such as coughing and rising from sitting.
(3) Patient education tools
Recommendation 3.1: Verbal and written instructions of PFMT should be given
to patients for home practice. (Grade A)
All the reviewed studies provided verbal and written instruction to patients
for home practice. It is helpful to remind the technique of PFMT and increase
49
their compliance rate for the elderly patients (Chang et al., 1998 (2++); Glazener
et al., 2011a (1++); Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+);
Tibaek et al., 2007(1+)).
Recommendation 3.2: Visual reminder acts as a reminder to practice PFMT at
home. (Grade C)
A visual reminder such as a refrigerator magnet which contains information
on how to perform the PFMT was given to patients to increase their compliance
rate. In Ip (2004) (1-), patients demonstrated higher compliance rate of PFMT at
2 weeks after operation in magnet group but they are not demonstrated at 3
months after operation. However, patients appreciated it was a good reminder.
Therefore, this visual reminder pairs with early pre-operative PFMT will exhibit
greater effect.
(4) Frequency of follow-up sessions
Recommendation 4.1: After initial PFMT pre-operative teaching session, a
reminder session before discharge and a follow-up at 4th
week after operation are
suggested to monitor patients’ progress. (Grade A).
50
In the reviewed studies, re-education program of PFMT was important after
operation to clarify any misconceptions and reinforce their compliance. All
reviewed studies except Glazener et al. (2011a) conducted post-operative PFMT
before discharge (Chang et al., 1998 (2++); Hou et al., 2013 (1-); Ip, 2004 (1-);
Porru et al., 2001 (1+); Tibaek et al., 2007(1+)).
The most frequent duration of follow-up sessions were at 2nd
, 4th
and 12th
weeks after operation in the reviewed studies. However, the 4th
week session got
the most significant improvement of urinary incontinence, urinary symptoms,
pelvic floor muscle strength and quality of life (Chang et al., 1998 (2++); Hou et
al., 2013 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007(1+)). After that, the
frequency of follow-up sessions depends on the availability of manpower and
budget.
Summary of the above recommendations was shown in Appendix 9.
51
Chapter 4
Implementation Plan
After development of an evidence-based guideline in the previous chapter,
nurses of a local acute hospital are advised to conduct pelvic floor muscle
training with patients undergoing transurethral resection of prostate. A clear and
detailed implementation plan, which includes a communication plan, a pilot
study plan and an evaluation plan, is described.
4.1 Communication Plan
In the communication plan, potential stakeholders will be identified and
related communication process will be discussed.
4.1.1 Identifying the stakeholders
Stakeholders should be identified before formulating the communication
plan. There are five major groups of stakeholders anticipated in this innovation.
52
Firstly, stakeholders at the administrative level are most powerful and
influential. The Consultant of the Urology team, the Department Operational
Manager (DOM) and Ward Managers (WMs) of day ward and urology ward are
responsible for monitoring and managing the quality of care in the setting. They
decide whether the proposed program will be funded or approved. Getting their
supports help to implement and run the proposed program efficiently as they can
act as a liaison among all staffs and have ability to coordinate and assign work to
staff in the innovation.
Secondly, urology nurses in day ward are responsible for providing
pre-operative assessment and investigations to patients with elective urology
operations. They are the main program conductors. They are directly affect and
are responsible for the implementation of the proposed program. Gaining of their
support is vital for the innovation. They are responsible for promotion of quality
of life by gaining urinary continence and reducing post-operative complications.
Thirdly, all urology doctors will be involved in the program, and the
Consultant of the Urology team will be invited to be an adviser on the program.
Doctors are collaborative partners in the innovation as they are responsible to
53
introduce the program to potential patients, answer their questions and arrange
patients admitted to pilot day ward one week before TURP for pre-operative
assessment. After TURP, doctors arrange combine follow-up appointments with
urology nurses to those patients.
Fourthly, nurses in day ward and urology ward are conductors of the
innovation. The workload and stress may be increased because they need to
acquire knowledge and skills and integrate the innovation into their nursing care.
The difficulty is not large as the education of PFMT is extended from radical
prostatectomy patients to TURP patients. To reduce any resistance, details of the
program will be disseminated and time allowed for review will be available to
them; and education sessions with demonstration will be given to them.
Lastly, men who will be referred to the proposed program by doctors or
nurses are stakeholders of the program. They are being informed of their right to
choose whether to join the proposed program.
4.1.2 The communication process
The process of the communication includes communication sequences of
54
the stakeholders and how to initiate, guide and sustain the change.
The program coordinator is a key person in communicating with different
stakeholders and responsible for providing a clear vision of the program and its
aims, needs and significance, the best evidence from a wide range critical
appraisal review, and its transferability, feasibility and cost-benefit analysis.
The urology nurse is the first person to be contacted informally as he will be
the major program conductor. As mentioned before, gaining his support is the
key success of the program. A full written proposal and guideline emphasized the
importance of the development of an evidence-based PFMT program to reduce
urinary incontinence for patients undergoing TURP will be given to him.
Recommendations may be obtained from him who is useful to finalize the pilot
study proposal. Then, the proposed program will be presented to the
administrators along with him.
A formal meeting will be arranged with the WMs of the day ward and
urology ward, and the DOM. A clear and precise power point presentation with a
55
written proposal will be prepared to communicate. A meeting with the
Consultant of the Urology team will be arranged after gaining their operational
approval. As they are the budget holders, the cost-benefit ratio of the proposed
program will be illustrated in the meetings.
After gaining their support, the information of the proposed program will be
disseminated to the urology doctors, WMs, urology nurses and frontline nurses
who will be involved. A formal departmental meeting will be arranged to
disseminate the information of the proposed program to the nurses and doctors,
which is held every three months. Also, the information of the proposed program
will be disseminated via multiple channels which are include internal e-mails
and ward briefing sessions as well.
4.1.3 Initiating, guiding and sustaining the change
To initiate the proposed change, a working group will be formed to
facilitate communication between nurses in different working areas and provide
feedback to improve the nursing practice. It includes four members, program
coordinator, urology nurse and one nurse representative from day ward and
urology ward.
56
The aims of the innovation are clearly stated that patients will not develop
urinary incontinence or will regain urinary continence after PFMT. An
evidenced-based guideline was developed with the wide ranged critical review
showing that PFMT is an effective conservative treatment for TURP patients. A
pocket guide with aims, guideline and patient journey of the innovation will be
designed and distributed for quick references.
To implement the innovation, an action plan with a clear time frame will be
established. In the program, obtaining approval from the above stakeholders will
last for three months. Then, a three-month pilot study will be implemented to test
the guideline and evaluate the proposed changes.
Before the pilot study, two identical one hour briefing sessions introduce
PFMT and the evaluation of the muscle strength; and the program details will be
given to all involved nurses. It is provided by urology nurses and organized by
the program coordinator. Ward conferences will be held monthly to provide
educational and feedback channels. Besides, the logistic arrangements for the
design and adequate supply of the pocket guide, information leaflet, posters and
57
refrigerator magnets are the responsibility of the working group.
In order to ensure the sustainability of the proposed program, the working
group will monitor and evaluate the effectiveness of the proposed change
continuously by observing patient outcomes such as incident rate, severity of
urinary incontinence, quality of life and satisfaction. Also, observing nurse’s
outcomes in self-perceived skill, confidence level and satisfaction with the new
guideline by means of questionnaires. If the pilot program showed significant
benefit to those patients, the program will be promoted to all patients receiving
TURP in the hospital.
4.2 Pilot Study Plan
A 6-month pilot study will perform before the full-scale implementation of
the program. Before the pilot study, all nurses in the pilot wards will be
completely trained by lecture and ward conferences. However, only nurses with
more than five years of experience will be recruited in this pilot study. There are
26 nurses in the pilot wards, of whom 13 nurses have more than five years of
experience. To ensure the reliability, all nurses must pass the practical
assessment on PFMT by urology nurses. Also, they must be evaluated to ensure
58
understanding of the measurement and evaluation tools.
It will be carried in a urology ward and a day ward respective to the
workflow. If the patients admitted for elective TURP with at least one week
pre-admission assessment in day ward and meet the required eligibility criteria
of cognitive intact and able to understand the instructions, they will become
target participants. If patients were planned or receiving bradytherapy, with
urethral or pelvic surgery, suffering from neurological disease or cognitive
impairment will be excluded in this study.
Also, the measuring and evaluation tools will be tested to evaluate the
outcome effectively and accurately. They include voiding diary, the International
Consultation on Incontinence Modular Questionnaire - Urinary Incontinence
Short Form in English (ICIQ-UI SF) (Appendix 10) and the validated Chinese
version (Appendix 11); and pelvic floor muscle strength assessment by using
Modified Oxford Scale. Nurses will record patients’ incontinence status and
pelvic floor muscle strength before operation and patient progress in patient
progress form after operation. Patients will be followed up at 4th
and 12th
week
after operation. Then, the compliance of nurses and patients will be monitored by
59
patient progress form.
For nurses, they can bring out their concerns or difficulties through monthly
ward conferences and evaluation questionnaire as well. A questionnaire
concerning the self-perceived level of competency in skills and knowledge in
implementing the program and the satisfactory level of the program is designed
(Appendix 12).
After the pilot study, the proposed innovation will be reviewed according to
the collected data about the patients’ outcomes and nurses’ concern, logistic
supply and usage of resources. A formal meeting will be held to explain any
modification made to the program and announce full-scale implementation in the
pilot urology and day wards.
4.3 Evaluation Plan
The evaluation plan is to examine the effectiveness of the program and to
evaluate the clinical benefits of the proposed program.
60
4.3.1 Nature of clients to be involved
The inclusion and exclusion criteria for patients to be evaluated are the
same as the pilot study plan and based on the identified evaluation studies. All
the recruited patients will be evaluated. Also, all nurses working in the urology
and day wards; and two urology nurses are the conductors of the program. They
are subject to be evaluated.
4.3.2 Outcomes measurement
The patient, healthcare provider and program outcomes will be measured in
order to examine whether the program will achieve its objectives and clinical
benefits.
Patient outcomes
The primary outcome of this innovation program is the continence rate;
other two secondary outcomes are the severity of urinary incontinence and the
impact on quality of life of urinary incontinence.
Based on the reviewed studies, the continence rate was mostly measured by
self-reporting 48 hours voiding diary (Chang et al., 1998; Glazener et al., 2011;
61
Hou et al., 2013; Porru et al., 2001). Patients need to return their voiding diaries
on the day of pre-admission assessment in day ward and follow-ups in clinic at
4th
and 12th
week after discharge (Chang et al., 1998; Hou et al., 2013; Porru et al.,
2001). Patients will be defined as continence if no leaking of urine was noted.
In addition, the severity and frequency of the incontinence are measured in
voiding diary and the ICIQ-UI SF. Simultaneously, ICIQ-UI SF measures the
impact of urinary incontinence to quality of life (Glazener et al., 2011).
ICIQ-UI SF has been fully validated and published; it gets a grade “A”
highly recommended self-reporting tool in evaluating the severity of urinary
incontinence and the impact of symptoms of urinary incontinence on quality of
life and outcome of treatment (Abrams et al., 2006).
ICIQ-UI SF mainly consists of 4 brief questions. One of the questions will
ask patient about the impact of everyday life, score (1-10). The lowest score
reflects the least impact on quality of life related to urinary incontinence. Finally,
an ICIQ score (0-21) yield from questions. The highest score reflects the highest
frequency and the largest amount of urinary incontinence with the greatest
62
impact on quality of life.
Questionnaire is self-reported by patient or with the help of a nurse to ask
him the questions. Measurements are taken on the day of pre-admission
assessment and at 4th
and 12th
weeks post-operatively (Chang et al., 1998;
Glazener et al., 2011; Hou et al., 2013; Porru et al., 2001).
Healthcare provider outcomes
The healthcare provider outcomes of self-perceived level of competency in
skills and knowledge in implementing the program, and satisfactory level of the
program are measured by a self-designed questionnaire (Appendix 12).
Questionnaires will be collected after the training sessions and the
implementation of the pilot program. Personal identification information is not
included in the questionnaire to ensure honest response.
Program outcomes
To measure program effectiveness, the utilization of the program, assigned
manpower and costs evaluation are the basic measures. The program utilization
rate will be calculated by the number of patients who are willing to join the
63
program over all eligible patients. Also, patients’ attendance and attrition rates
will be used for measuring utilization rate. The patient progress form, from
pre-admission assessment to post-operative follow up, will be used to evaluate
the utilization of the program. Nurses need to enter the information about
patients’ attendance, voiding diary, pelvic muscle strength assessment and the
practice of pelvic floor muscle exercise at home. Also, nurses need to record the
education and advice given in every session of interview and on day of
discharge.
The actual costs of the program will be calculated. The material cost of the
program is low; it is mainly from the design and photocopying of the information
sheets, posters, patient progress forms and the refrigerator magnets. Manpower
is the major expenses in the program. It will be measured from the patient
progress form which will be collected after the implementation of the pilot
program. All the expenditure will be carefully recorded and controlled as a base
of the full implementation of the program.
4.3.3 Number of patients to be involved
The number of patients to be involved depends on the primary outcome of
64
the program and the data analysis method. This study is a pre-test and post-test
design, two-tailed paired t-tests will be used for the calculation of the sample size.
The program is to determine the continence rate is changed since the
implementation of the innovation.
From the reviewed study (Porru et al., 2001), the continence rate in 3 weeks
(80% vs 12.8%), with the power set at 90% and the level of significance at 0.01,
the number of patients was 22. The dropout rate was 5.17% in 4 weeks, that is,
the sample size will be 23.2 patients. In the three reviewed studies with 12 weeks
program, the dropout rates ranged from 0 to 15.52% (Hou et al., 2013; Ip, 2004;
Tibaek et al., 2007).
From the previous data, there were about 11 patients underwent elective
TURP with the pre-admission system per month; of which, 26 patients will be
required for 15.52% dropout rate in a 12 weeks program. It is estimated that
recruitment of 52 patients in the 12 weeks program would take about 6 months.
4.3.4 Data analysis
The primary outcome – continence rate is the proportion of patients whose
65
urine loss is zero as recorded in 48 hours voiding diary. The increased percentage
of patient getting continence indicates the degree of effectiveness of this
program.
The severity of urinary incontinence is measured in one of the question in
ICIQ-UI SF. It is categorized into four degrees and scores (0-6), none (0), a small
amount (2), a moderate amount (4) and a large amount (6). The program is
considered effective if the mean score decreased.
The degree of impact of urinary incontinence affects patients’ quality of life
was indicated in one of the question in ICIQ-UI SF. It is a 10 point scale; the
lowest point means not a trouble, the highest point mean a great trouble in daily
life. Finally, an ICIQ (0-21) score is the sum score of the ICIQ-UI SF. The
decrease of these mean scores indicates the success of the program.
Descriptive statistics will be used to summarize patients’ demographic data.
In addition, pre- and post-interventions will be analyzed by paired t-tests. They
will apply to detect the mean change in frequency and amount of urine loss,
degree of impact in daily quality of life, ICIQ score, pelvic floor muscle strength,
66
patients’ average time for exercise per week in cycle, patients’ and nurses’
satisfaction level, nurses’ self-perceived skill and confidence level.
4.3.5 Criteria for considering the program effective
The program will be considered as effective if the outcomes are achieved.
Since the primary outcome of the program is urine continence, if the mean of
continence rate is increased after 12 weeks of PFMT program, the program will
be considered effective.
The program will also be considered effective if it shows a statistically
significant positive effect on the patients’ mean change of the amount of urine
loss, impact of the quality of life score and the ICIQ score. At least 70% of the
patient progress form is fully completed.
In addition, the program will also be considered as effective if 70% or more
of patients and nurses choose “agree” or above in the questionnaire for their
satisfaction level; and achieved 80% of nurses choose “agree” or above in the
self-perceived skill and confidence level.
67
For the utilization of the program, the program will be considered as
effective if 70% or more of the eligible patients show their willingness to join the
program, patients’ attendance rate is higher than or equal to 70%, and the patients’
attrition rate is less than or equal to 15%. For the costs of the program, if the total
expenditure of the program is within the budget limit, the program will be
considered as effective.
68
Chapter 5
Conclusion
In conclusion, this thesis proposes an evidence-based pelvic floor muscle
training program to reduce urinary incontinence for patients undergoing
transurethral resection of prostate in a local acute hospital. It aims to reduce the
complications related to post-operative urinary incontinence by practicing
PFMT and to improve their quality of life.
The development of the guideline is brought through the systematic
literature searching and quality assessment of the reviewed articles. Articles
include five RCTs and one controlled trial.
The proposed PFMT program is affirmed its implementation potential. It is
analysed and resulted with high local transferability and feasibility, and low
cost-benefit ratio. Also, the potential risk exposes to patients is minimal. It is
worth to implement it in local clinical setting as discussed.
69
Based on the reviewed studies and local clinical setting, the evidence-based
PFMT guideline is developed based on four parts. They are assessment and
outcome measurements, PFMT instructions, patient education tools and
frequency of follow-up sessions. After that, an implementation plan which
includes a communication plan, a pilot study plan and an evaluation plan are
designed to guide its implementation in the local clinical setting.
Finally, it hopes that the developed evidence-based PFMT program can
provide healthcare providers, especially nurses, with an evidence-based
approach to promote PFMT to reduce the duration or amount of urinary
incontinence for patients after TURP and improve their quality of life. In turns, it
reduce the social and health burden of the society.
70
List of Appendices
Appendix 1: Search Strategies and Result
A search of literature was conducted on 18 August 2013.
Item
No.
Database
Keyword
CINAHL
Plus
(1993 - 18
August
2013)
PubMed
(1993 - 18
August
2013)
Science
Direct
(1993 -
18 August
2013)
British
Nursing
Index
(1993 - 18
August 2013)
#1 Prostate 15048 127160 209142 688
#2 Urinary incontinence 6612 32816 38119 799
#3 Pelvic floor 1890 8365 24202 215
#4 #1 and #2 and #3 1 96 1724 8
#5 Transurethral resection
of prostate
5217 10319
#6 #4 and #5 17
462
#7 Benign prostate
hyperplasia
37338
#8 Pelvic floor muscle
exercise
4459
#9 #6 and #7 288
#10 #8 and #9 112
Selected articles after
screening title and
abstract
1 6 2 2
Selected articles after
screening full paper
with inclusion and
exclusion criteria
1 6
2
2
Total number of trials
selected after singling
out duplicated studies
6 randomized controlled trials
71
Appendix 2:
Table of the Scottish Intercollegiate Guidelines Network (SIGN) Grading
System
Levels of Evidence
Level Description
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of
bias
1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort or studies
High quality case control or cohort studies with a very low risk of confounding or bias
and a high probability that the relationship is causal
2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and
a moderate probability that the relationship is causal
2- Case control or cohort studies with a high risk of confounding or bias and a significant
risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
Grades of Recommendations
A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly
applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the
target population, and demonstrating overall consistency of results
B A body of evidence including studies rated as 2++, directly applicable to the target
population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+, directly applicable to the target
population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+
Good practice points
Recommended best practice based on the clinical experience of the guideline development
group
72
Appendix 3: Tables of Evidence
Bibliographic
citation
Study type
Evidence
level
Number of
patients
Patient
characteristics
Intervention Comparison Length of
follow up
Outcome measures Effect size
Intervention vs Comparison
Chang et al.
(1998)
Controlled
trial
2++
N = 50
Dropout: 0
The first 25
men served
as a control
group, the
next 25 men
were the
intervention
group
Men with BPH
underwent TURP.
Inclusion criteria:
Age < 80 years,
frequency, terminal
dribbling, urinary
incontinence,
ambulatory and
communicable.
Exclusion criteria:
pelvic surgery,
urethral surgery,
neurogenic bladder.
n = 25
- Perform PFMT
every day after
removal of
urinary
catheter in 1-2
days after
operation
- Attend clinic
weekly for
evaluating
PFMT
- PFMT daily at
home
- Mean age = 65
(51 – 74) years
n = 25
- No PFMT
- Mean age =
64 (45-79)
years
(a) Before
operation
(b)1 week
(c) 2 week
(d) 3 week
(e) 4 week
after
operation
(1) Men with
incontinence
(2)Men with
terminal
dribbling
(3)AUA symptom
score
(4)Pelvic floor
muscle strength
(5) Uroflowmetry
parameters
(6)Voiding interval
(minutes)
(7)Patient
satisfaction
score:
(1d) 1 vs 9 (p < 0.05)
(1e) 1 vs 8 (p < 0.05)
(2e) 3 vs 10 (p < 0.05)
(3a) 23 vs 22
(3b) 11 vs 10
(4e) Grade 1: -8% (p < 0.05)
Grade 2: -3% (p < 0.05)
Grade 3: 0% (p < 0.05)
Grade 4: 5% (p < 0.05)
(5) No significant difference
(6b) 30.4 (p < 0.01)
(6c) 43.2 (p < 0.01)
(6d) 41.6 (p < 0.01)
(6e) 43.4 (p < 0.01)
(7e) (i) -4.36 (p < 0.01)
(ii) -1.12
73
(i) total score
(ii) emotional
(iii) psychological
& social
(iv) physical
(iii) -2.89 (p < 0.01)
(iv) -0.84
General comment:
- Pelvic floor muscle strength- digital rectal examination, grade (0, none – 4, strong).
- It is a controlled trial. Method of subject allocation is not randomized. The concealment is not mentioned. The blinding is not possible.
- PFMT helped to regain continence, reduce urinary symptoms and improve quality of life after 4 weeks.
74
Bibliographic
citation
Study type
Evidence
level
Number
of
patients
Patient
characteristics
Intervention Comparison Length of
follow up
Outcome measures Effect size (95% CI), p value
Glazener et al.
(2011a)
RCT
1++
N = 442
Dropout:
45
Men with
persistent
urinary
incontinence at
6 weeks after
TURP in 34 UK
centers
Exclusion
criteria:
Men had been
received formal
PFMT, after
channel TURP,
radiotherapy.
n = 220
Lifestyle advice
leaflet and 4
individual
PFMT sessions
with a therapist
in 3 months
An PFMT
leaflet was given
for home
exercise
program
Mean age = 68.2
± 7.7 years
n = 222
Standard care to
provide lifestyle
advice leaflet
only, no PFMT.
Mean age = 67.9
± 8.1 years
Baseline, 3,
6, 9 and 12
months after
randomizatio
n
(1)Men with
incontinence
(2)ICI-Q score
(3)PFME compliance
(4)Use of aids
(5)EQ-5D
(6)SF-12 mental
(7)SF-12 physical
(8)QALYs
Other outcomes:
urinary frequency,
nocturia, urgency,
erectile dysfunction,
faecal incontinence,
constipation
(1) 1.06 (0.91 to 1.23), 0.47
(2) -0.04 (0.78 to 0.71), 0.93
(3) 3.20 (2.37 to 4.32), 0.001
(4) 0.91(0.56 to1.46), 0.68
(5) -0.01 (-0.04 to 0.03), 0.79
(6) -0.04 (-1.71 to 1.63), 0.96
(7) 0.39 (-1.22 to 1.99), 0.64
(8) -0.00003 (-0.026 to 0.026)
General comment:
The intervention increases the PFMT compliance. It does not result in better short-term or medium-term continence rate or quality of life.
75
One to one teaching of PFMT is unlikely to be effective or cost-effective compared to standard care with provision of lifestyle advice leaflet.
There were high rate of men with urinary incontinence in both intervention and control groups (64.9% and 61.6%) after 12 months. It may indicate a substantial unrecognized
complicated urinary incontinence after TURP.
Information about PFMT was freely available in the study area; there was 21% of the subjects doing PFMT after TURP before randomization.
76
Bibliographic
citation
Study type
Evidence
level
Number of
patients
Patient
characteristics
Intervention Comparison Length of
follow up
Outcome measures Effect size
Hou et al.
(2013)
RCT
1-
N = 66
Excluded:
2 with
foley
catheter on
discharge
Dropout: 3
was lost in
follow-up
Men with BPH
underwent TURP.
Inclusion criteria:
Age: 60-90 years,
remarkable LUTS,
ambulatory and
able to
communicate
verbally.
Exclusion criteria:
Discharge with
urinary catheter,
neurogenic bladder,
and dementia.
n = 32
- Perform PFMT
every day after
removal of urinary
catheter 2 days
post-operatively
- Apply EMG to
confirm correct
PFMT
- Reminded by
telephone at least
once a week
- Mean age = 69.67±
6.09 years
n = 29
- No PFMT
- Mean age =
71.41 ± 6.67
years
Before
operation
and
1, 4, 8, 12
weeks after
operation
(1)Men with
incontinence (4
weeks)
(2)IPSS (4 weeks)
- Voiding score
- Storage score
(3) Q max
(4) VV
(5) PVR
(6) SF-36 physical
(7) SF-36 mental
(1) 3vs 2 = 0 vs 0
(2) -3.01 (p <0.001)
- 0.51 (p = 0.511)
- 2.87 (p < 0.001)
(3) 4 (p = 0.026)
(4) 31.98 (p = 0.097)
(5) -7.44 (p = 0618)
(6) 5 (p = 0.029)
(7) 7.69 (p = 0.005)
General comment:
Detail method of randomization was not mentioned.
“Subject-expectancy effect” might cause some biased in this study as a complete educational program was only provided to the interventional group.
77
Bibliographic
citation
Study type
Evidence
level
Number of
patients
Patient
characteristics
Intervention Comparison Length of
follow up
Outcome measures Effect size
Ip (2004) RCT
1-
N = 16
English
speaking male
patients
undergoing
either radical
prostatectomy
(RP) or TURP.
Mean age – not
mentioned
n = 9
(TURP: 6,
RP: 3)
Information on
bladder habit
and PFMT on a
refrigerator
magnet was
given in the
pre-admission
clinic
n = 7
(TURP: 5,
RP: 2)
Information on
bladder habit
and PFMT on a
paper handout
was given in the
pre-admission
clinic
Before
operation
and telephone
survey after
operation at:
(a) 2 weeks
(b) 3 months
(1) St. George
Urinary
Incontinence
Score
(2) PFMT compliance
Magnet vs Paper (%)
(1a) 55.6 vs 42.9
(1b) 33.3 vs 28.6
(2a) 66.7 vs 57.1
(2b) 66.7 vs 85.7
General comment:
St. George Urinary Incontinence Score, 5 items with score 0 (never) – 4 (always), total score = 0-20.
The sample size is small due to the premature call-off (restructure of pre-admission clinic).
No evidence of men with magnet group with higher compliance of PFMT or continence compared to paper group.
78
Bibliographic
citation
Study type
Evidence
level
Number of
patients
Patient characteristics Intervention Comparison Length of
follow up
Outcome measures Effect size
Porru et al.
(2001a)
RCT
1+
N = 58
Dropout: 3
Men with BPH
undergoing TURP
Exclusion criteria:
Aged over 80 years
old or with urethral or
pelvic surgery,
neurogenic bladder or
prostatic cancer.
n = 28
PFMT teaching
pre-operative and
training sessions
at follow-up
(weeks 1, 2, 3, 4)
and written
instruction for
home PFMT
Mean age = 66
(53-71) years
n = 27
Not specified
Mean age =
67.5 (55-73)
years
Before
operation
and
(a) 1 week
(b) 2 week
(c) 3 week
(d) 4 week
after
TURP
(1) No. of incontinence
patient by voiding
diaries
(2) AUA Symptom Score
(3) ICS male questionnaire
(4) PFM contraction
strength
(5) Voiding interval
(6) Uroflowmetry
parameters
(1a) –8 (p < 0.01)
(1b) –11 (p < 0.01)
(1c) –8 (p < 0.01)
(1d) Not significant
(2d) Not significant
(3d) -1.7 (p < 0.001)
(4d) 1.4 (p < 0.01)
(5b) 35.5 (p < 0.01)
(5d) 8.5 (p < 0.01)
(6d) Not significant
General comment:
Significant less continence in the intervention group at 1, 2, 3 weeks, but no different at 4 weeks after operation.
PFMT helps men to regain continence earlier after TURP.
79
Bibliographic
citation
Study type
Evidence
level
Number of
patients
Patient
characteristics
Intervention Comparison Length of follow
up
Outcome measures Effect size
Tibaek, et al.
(2007)
RCT
1+
N = 58
Dropout: 9
Randomization
by grouping in
blocks of ten in a
mathematical
table
Ambulatory men
with
uncomplicated
benign prostate
obstruction who
were planned for
TURP.
Exclusion criteria:
prostate cancer,
previous lower
urinary tract
surgery,
neurological
disease.
n = 26
Start at
pre-operatively,
PFMT individual
and group lessons,
and home training
program.
Give verbal
instructions after
TURP.
Mean age:70
(58-77) years
n = 23
No
pre-operative
PFMT.
Give PFMT
knowledge
and verbal
instructions 2
to 3 days after
TURP.
Mean age: 68
(52-79) years
Before operation
and
(a) 2 weeks
(b) 4 weeks
(c) 3 months
after
operation
(1) UI (pad test
g/24 hours)
(2) PFMT
compliance
(3) DAN-PSS-1
score
(4) PFM - static
endurance
(5) PFM - dynamic
endurance
(6) Voiding
parameters
(1b) 8 (p = 0.755)
(2) 24/26 attended
all training
sessions
(3a) 2.5 (p =
0.927)
(3b) 5 (p = 0.452)
(3c) -1 (p = 0.754)
(4b) 86% vs
12.5%
improvement
(p = 0.004 vs
0.172)
(5b) 16 (p = 0.049)
(6) No significant
differences
General comment:
80
DAN-PSS-1: Danish Prostatic Symptom Scale, ranges from 0-108.
The exact duration of practicing pre-operative PFMT was not mentioned, it might affect the study result directly.
81
Appendix 4: Methodology Checklists
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Chang, P. L., Tsai, L. H., Huang, S. T., Wang, T. M., Hsieh, M. L., & Tsui, K. H.
(1998). The early effect of the pelvic floor muscle exercise after transurethral
prostatectomy. The Journal of Urology, 160, 402-405.
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an
appropriate and clearly focused
question.
Yes.
1.2 The assignment of subjects to
treatment groups is randomised.
No. Allocated the groups by preceding
and subsequent subjects without
randomization.
1.3 An adequate concealment
method is used
No. Allocation concealment is not
mentioned.
1.4 Subjects and investigators are
kept ‘blind’ about treatment
allocation.
No. Subjects and therapists cannot be
blinded except the data entry clerical staff.
1.5 The treatment and control groups
are similar at the start of the trial.
Yes
1.6 The only difference between
groups is the treatment under
investigation.
Yes
1.7 All relevant outcomes are
measured in a standard, valid and
reliable way.
Yes
1.8 What percentage of the
individuals or clusters recruited
into each treatment arm of the
0/50 x100% = 0%
82
study dropped out before the
study was completed?
1.9 All the subjects are analysed in
the groups to which they were
randomly allocated (often
referred to as intention to treat
analysis).
Does not apply. All participants were
accounted for and none was lost to
follow-up at 4 weeks period.
1.10 Where the study is carried out at
more than one site, results are
comparable for all sites.
Does not apply. This study is carried out in
one site.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to
minimise bias?
Acceptable (+)
2.2 Taking into account clinical
considerations, your evaluation
of the methodology used, and
the statistical power of the study,
are you certain that the overall
effect is due to the study
intervention?
The overall effect is due to the study
intervention even the method of subjects
allocation is not randomised.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?
Yes. High participation rate (100%, n =
50). It can be applied to the target patient
group.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own
assessment of the study, and the extent to which it answers your question and
mention any areas of uncertainty raised above.
PFMT is useful in reducing urinary incontinence and terminal dribbling in 4
weeks after TURP, and provides better psychological and social quality of life.
This study should be a controlled trial
83
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Glazener, C., Boachie, C., Buckley, B., Cochran, C., Dorey, G., Grant, A., Hagen,
S., Kilonzo, M., McDonald, A., McPherson, G., Moore, K., N' Dow, J., Ramsay,
C., & Vale, L. (2011a). Conservative treatment for urinary incontinence in men
after prostate surgery (MAPS): two parallel randomized controlled trials. Health
Technology Assessment, 15(24), 1-290.
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an
appropriate and clearly focused
question.
Yes
1.2 The assignment of subjects to
treatment groups is randomised.
Yes. Remote computer allocation.
1.3 An adequate concealment
method is used
Yes
1.4 Subjects and investigators are
kept ‘blind’ about treatment
allocation.
No. Subjects and therapists cannot be
blinded except the data entry clerical staff.
1.5 The treatment and control groups
are similar at the start of the trial.
Yes
1.6 The only difference between
groups is the treatment under
investigation.
Yes
1.7 All relevant outcomes are
measured in a standard, valid and
reliable way.
Yes
1.8 What percentage of the
individuals or clusters recruited
into each treatment arm of the
study dropped out before the
45/442 x 100% = 10.18%
84
study was completed?
1.9 All the subjects are analysed in
the groups to which they were
randomly allocated (often
referred to as intention to treat
analysis).
Yes
1.10 Where the study is carried out at
more than one site, results are
comparable for all sites.
Yes, there is no marked difference in the
34 UK centers data reported
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to
minimise bias?
High quality (++)
2.2 Taking into account clinical
considerations, your evaluation
of the methodology used, and
the statistical power of the study,
are you certain that the overall
effect is due to the study
intervention?
The overall effect is due to the study
intervention as it demonstrates good
randomization, allocation concealment
and possible blinding techniques.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?
Yes. High participation rate (86%, 442 of
512) and the large number of UK centers
contributes participants, findings can be
generalized.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own
assessment of the study, and the extent to which it answers your question and
mention any areas of uncertainty raised above.
The intervention increases the PFMT compliance. It does not result in better
short-term or medium-term continence rate or quality of life.
One to one teaching of PFMT is unlikely to be effective or cost-effective
compared to standard care with provision of lifestyle advice leaflet. There are
high rate of men with urinary incontinence in both intervention and control
groups (64.9% and 61.6%) after 12 months. It may indicate a substantial
unrecognized complicated UI after TURP.
21% of the subjects doing PFMT after TURP before randomization.
Information about PFMT is freely available; it is not possible to identify a
control group that was unaware of PFM exercise.
85
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Hou, C. P., Chen, T. Y., Chang, C. C., Lin, Y. H., Chang, P. L., Chen, C. L., Hsu, Y. C.,
& Tsui, K. H. (2013). Use of the SF-36 quality of life scale to assess the effect of
pelvic floor muscle exercise on aging males who received transurethral prostate
surgery. Clinical Intervention in Ageing, 8, 667-673.
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an
appropriate and clearly focused
question.
Yes
1.2 The assignment of subjects to
treatment groups is randomised.
Can’t say. Randomization is mentioned,
but method is not specified.
1.3 An adequate concealment
method is used.
No. Concealment method is not
mentioned.
1.4 Subjects and investigators are
kept ‘blind’ about treatment
allocation.
Cant’ say. The presence of blinding is not
mentioned. Blinding of special
technicians teaching PFMT cannot be
blind.
1.5 The treatment and control groups
are similar at the start of the trial.
Yes
1.6 The only difference between
groups is the treatment under
investigation.
Yes
1.7 All relevant outcomes are
measured in a standard, valid and
reliable way.
Yes
1.8 What percentage of the
individuals or clusters recruited
into each treatment arm of the
study dropped out before the
study was completed?
5/66 x100% =7.58%
86
1.9 All the subjects are analysed in
the groups to which they were
randomly allocated (often
referred to as intention to treat
analysis).
Yes
1.10 Where the study is carried out at
more than one site, results are
comparable for all sites.
Does not apply. This study is carried out in
one site.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to
minimise bias?
Acceptable (+)
2.2 Taking into account clinical
considerations, your evaluation
of the methodology used, and
the statistical power of the study,
are you certain that the overall
effect is due to the study
intervention?
The overall effect is due to the study
intervention. The methodology was not
mentioned clearly in randomization,
allocation concealment and blinding.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?
Yes. The mean age and urinary
symptoms of subjects are typical
presentations of the TURP patients.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own
assessment of the study, and the extent to which it answers your question and
mention any areas of uncertainty raised above.
Patients who performed PFMT for 12 weeks with closed monitoring by health
care professionals after TURP showed quicker improvement of urinary
symptoms especially in storage symptoms; and their quality of life than those
without PFMT.
87
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Ip, V. (2004). Evaluation of a patient education tool to reduce the incidence of
incontinence post-prostate surgery. Urologic Nursing, 24(5), 401-407.
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an
appropriate and clearly focused
question.
Yes
1.2 The assignment of subjects to
treatment groups is randomised.
Can’t say. Only convenience randomized
sampling was mentioned. Allocation
method was not mentioned.
1.3 An adequate concealment
method is used.
No. Concealment method is not
mentioned.
1.4 Subjects and investigators are
kept ‘blind’ about treatment
allocation.
No. Blinding is not possible for patients
and nurses
1.5 The treatment and control groups
are similar at the start of the trial.
Can’t say.
Only the compliance of PFMT and
incontinence score were mentioned in
baseline data.
1.6 The only difference between
groups is the treatment under
investigation.
Yes
1.7 All relevant outcomes are
measured in a standard, valid and
reliable way.
Can’t say. Only the numbers of patient
performing PFMT and incontinence score
were presented. No statistical
measurement was mentioned.
1.8 What percentage of the
individuals or clusters recruited
into each treatment arm of the
study dropped out before the
study was completed?
0/16 x100% = 0%
88
1.9 All the subjects are analysed in
the groups to which they were
randomly allocated (often
referred to as intention to treat
analysis).
Not applicable. All participants were
accounted for and none was lost to
follow-up at 3 months period.
1.10 Where the study is carried out at
more than one site, results are
comparable for all sites.
Not applicable. This study is carried out
in one hospital center.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to
minimise bias?
Low quality (0)
2.2 Taking into account clinical
considerations, your evaluation
of the methodology used, and
the statistical power of the study,
are you certain that the overall
effect is due to the study
intervention?
The overall effect of the study was
difficult to say as it only mentioned
randomized convenience sampling
method. The result was presented without
any statistical measurement. The major
limit of this study was the very small
sample size due to be terminated
prematurely.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?
No, too small sample size.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own
assessment of the study, and the extent to which it answers your question and
mention any areas of uncertainty raised above.
Inconclusive due to the study was terminated prematurely. Men in magnet
group seemed to get better incontinence score than those in paper group. A
visual reminder might be helping in adhering the PFMT.
89
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Porru, D., Campus, G., Caria, A., Madeddu, G., Cucchi, A., Rovereto, B., Scarpa,
R. M., Pill, P., & Usal, E. (2001). Impact of early pelvic floor rehabilitation after
transurethral resection of the prostate. Neurourology and Urodynamics, 20, 53-59.
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an
appropriate and clearly focused
question.
Yes
1.2 The assignment of subjects to
treatment groups is randomised.
Can’t say. Only randomization is
mentioned, but method not specified.
1.3 An adequate concealment
method is used.
No. The concealment method is not
reported
1.4 Subjects and investigators are
kept ‘blind’ about treatment
allocation.
Yes. A double blinding study. An urologist
performing digital evaluation of pelvic
floor muscle contraction was blinded to
the study group.
1.5 The treatment and control groups
are similar at the start of the trial.
Yes
1.6 The only difference between
groups is the treatment under
investigation.
Yes
1.7 All relevant outcomes are
measured in a standard, valid and
reliable way.
Yes
1.8 What percentage of the
individuals or clusters recruited
into each treatment arm of the
study dropped out before the
study was completed?
3/58 x100% = 5.17%
90
1.9 All the subjects are analysed in
the groups to which they were
randomly allocated (often
referred to as intention to treat
analysis).
Yes
1.10 Where the study is carried out at
more than one site, results are
comparable for all sites.
Does not apply. This study is carried out in
one hospital center.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to
minimise bias?
Acceptable (+)
2.2 Taking into account clinical
considerations, your evaluation
of the methodology used, and
the statistical power of the study,
are you certain that the overall
effect is due to the study
intervention?
The overall effect is due to the study
intervention as it includes random
assignment in group allocation and
blinding of the assessor. However, the
method of randomization is not provided.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?
Yes.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own
assessment of the study, and the extent to which it answers your question and
mention any areas of uncertainty raised above.
PFMT starts in pre-operative produces a quicker improvement of incontinence
state, urinary symptoms and of QOL in patients after TURP.
91
S I G N
Methodology Checklist 2: Controlled Trials
Study identification (Include author, title, year of publication, journal title, pages)
Tibaek, S., Klarskov, P., Hansen, B. L., Thomsen, H., Andresen, H., Jensen, C. S., &
Olsen, M. N. (2007). Scandinavian Journal of Urology and Nephrology, 41, 329-334.
SECTION 1: INTERNAL VALIDITY
In a well conducted RCT study… Does this study do it?
1.1 The study addresses an
appropriate and clearly focused
question.
Yes
1.2 The assignment of subjects to
treatment groups is randomised.
Yes. Mathematical table, grouped in
blocks of ten.
1.3 An adequate concealment
method is used.
Yes. Sealed envelopes by independent
third party
1.4 Subjects and investigators are
kept ‘blind’ about treatment
allocation.
Yes. Single blinding. Independent
physiotherapist took pelvic floor
assessment before and 4 weeks after
operation. Not possible to blind the
patients and intervention physiotherapist.
1.5 The treatment and control groups
are similar at the start of the trial.
Yes
1.6 The only difference between
groups is the treatment under
investigation.
Yes
1.7 All relevant outcomes are
measured in a standard, valid and
reliable way.
Yes
1.8 What percentage of the
individuals or clusters recruited
into each treatment arm of the
study dropped out before the
study was completed?
9/58 x100% = 15.52%
92
1.9 All the subjects are analysed in
the groups to which they were
randomly allocated (often
referred to as intention to treat
analysis).
Yes
1.10 Where the study is carried out at
more than one site, results are
comparable for all sites.
Does not apply. This study is carried out in
one site.
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to
minimise bias?
High quality (++)
2.2 Taking into account clinical
considerations, your evaluation
of the methodology used, and
the statistical power of the study,
are you certain that the overall
effect is due to the study
intervention?
The overall effect is due to the study
intervention as it demonstrates good
randomization, allocation concealment
and blinding techniques. A good
reliability in pelvic floor muscle
assessment and PFMT teaching by one
physiotherapist.
2.3 Are the results of this study
directly applicable to the patient
group targeted by this guideline?
Yes.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own
assessment of the study, and the extent to which it answers your question and
mention any areas of uncertainty raised above.
Pre-operative PFMT produced a significant improvement in pelvic floor
muscle endurance after TURP. No differences between the groups in lower
urinary tract parameters. The exact duration of providing pre-operative PFMT
was not mentioned while the control group received verbal instruction about
PFMT after 2-3 days of operation. The length of practicing PFMT before
operation is a critical factor for significant result in this study.
93
Appendix 5: Summary of Levels of Evidence
Bibliographic citation Study Type Level of Evidence
Chang, et al. (1998) Controlled trial 2 ++
Glazener et al. (2011a) RCT 1 ++
Hou et al. (2013) RCT 1-
Ip (2004) RCT 1-
Porru et al. (2001) RCT 1+
Tibaek et al. (2007) RCT 1+
94
Appendix 6: Summary of Quality Assessment of the Selected Studies
Controlled Trials Checklist
Chang, et al.
(1998)
Glazener et
al. (2011)
Hou et al.
(2013)
Ip
(2004)
Porru et al.
(2001)
Tibaek et al.
(2007)
1 The study addresses an appropriate and clearly focused question. Yes Yes Yes Yes Yes Yes
2 The assignment of subjects to treatment groups is randomised. No Yes Can’t say Can’t say Can’t say Yes
3 An adequate concealment method is used. No Yes No No No Yes
4 Subjects and investigators are kept ‘blind’ about treatment allocation. No No Can’t say No Yes Yes
5 The treatment and control groups are similar at the start of the trial. Yes Yes Yes Can’t say Yes Yes
6 The only difference between groups is the treatment under investigation. Yes Yes Yes Yes Yes Yes
7 All relevant outcomes are measured in a standard, valid and reliable way. Yes Yes Yes Can’t say Yes Yes
8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was completed?
0% 10.18% 7.58% 0% 5.17% 15.52%
9 All the subjects are analysed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
Does not
apply
Yes Yes Does not
apply
Yes Yes
10 Where the study is carried out at more than one site, results are
comparable for all sites.
Does not
apply
Yes Does not
apply
Does not
apply
Does not
apply
Does not
apply
11 How well was the study done to minimise bias? Acceptable
(+)
High quality
(++)
Acceptable
(+)
Low quality
(0)
Acceptable
(+)
High quality
(++)
Level of evidence (SIGN, 2013) 2 ++ 1 ++ 1 - 1 - 1 + 1 +
95
Appendix 7: Summary of the Data of the Selected Intervention Studies
Bibliographic
citation
Study
design/
Evidence
level
Number of
patients/
Dropout rate
Intervention Comparison Data
collection
time
Outcome measures:
Significant difference result between intervention & comparison groups
Incidence of
incontinence
Urinary
symptoms
PFM
Strength
Quality of life
Chang, et al.
(1998)
Controlled
trial, 2++
N = 50
Dropout = 0%
n = 25
Post-op PFMT
n = 25
No PFMT
Before
operation, 1, 2,
3, 4 weeks after operation
voiding
diaries at 3, 4
weeks terminal
dribbling at 4
weeks
Voiding interval
at 2, 3, 4 weeks
× AUASS
4 weeks
Patient satisfaction
score - total, psycho &
social at 2, 3, 4 weeks
Glazener et al. (2011a)
RCT, 1++ N = 442 Dropout: 45/442
= 10.18%
n = 220 Post-op PFMT (after 6
weeks)
4 teaching sessions in 3 months
Biofeedback used in 13 men
n = 222 No PFMT
Before intervention, 3,
6, 9, 12 months
3 days voiding diaries at 3, 6, 9
12 months
× ICI-UISF
× uroflowmetry
parameters
NA PFMT
compliance
×ICIQ-UI SF
× ED-5D
× SF-12
QALYS
Hou et al. (2013)
RCT, 1- N = 66 Dropout: 5/66
= 7.58%
n = 32 Post-op PFMT
Use EMG
Phone interviews at least once/ week
n = 29 No PFMT
Before operation, 1, 4,
8, 12 weeks
after operation
× self-reporting IPSS - total & storage scores at 4
weeks
Uroflowmetry parameters: Q max
at 12 weeks
NA SF-36 physical SF-36 mental
at 12 weeks
Ip
(2004)
RCT, 1- N = 442
Dropout: 0/16 = 0%
n = 9
Pre-op PFMT Visual reminder- magnet
n = 7
Pre-op PFMT Paper reminder
Before
operation, 2, 12 weeks after
operation
× St. George
Urinary
Incontinence
Score
× IPSS NA
× PFMT
compliance
× St. George Urinary
Incontinence Score -
lifestyle
Porru et al.
(2001)
RCT, 1+ N = 58
Dropout: 3/58
=5.17%
n = 28
Pre-op PFMT, Training
sessions at 1,2,3 & 4 weeks after operation
n = 27
No PFMT
Before
operation,1, 2,
3, 4 weeks after operation
voiding
diaries at 1, 2, 3
weeks
× AUASS
voiding interval at 2 & 4 weeks
× uroflowmetry
parameters
at 4 weeks ICS- quality of life
at 4 weeks
Tibaek et al.
(2007)
RCT, 1+ N = 58
Dropout: 9/58
= 15.52%
n = 26
Pre-op PFMT
n = 23
No pre-op PFMT
Verbal instruction 2-3 days after
operation
Before
operation, 2, 4,
12 weeks after operation
× pad test × DAN-PSS-1
× voiding
parameters
at 4 weeks NA
96
Appendix 8: Recommendation from Synthesis Process
8.1 What are the suggested interventions in the PFMT regime?
PFMT starts
Measure &
grade PFM
strength
Time of
measurement
Therapists Treatment
- individual
- group
PFMT leaflet
for home
exercise
Lifestyle / Bladder
habit leaflet/
Biofeedback
Monitor the
compliance
Chang,
et al.
(1998)
Post-op
1-2 days
Pre-op
Modified
Oxford scale
Before &
weekly for 4
weeks after
TURP
Not mentioned Individual Not mentioned × PFM strength weekly
Glazener
et al.
(2011a)
Post-op
6 weeks after
Post-op
Modified
Oxford scale
Before & each
PFMT session
Physiotherapists
or continence
nurses
Individual
for 4 sessions
in 3 months
Verbal and
written
Lifestyle& bladder
training advice
leaflet
Biofeedback used in
13 men only
PFM strength in first 3
months (4 sessions)
only, then reported by
questionnaire
Hou et
al.
(2013)
Post-op
2 days × × Not mentioned Individual Not mentioned Apply EMG to
confirm correct
PFMT
Phone at least once a
week
Ip
(2004)
Pre-op
Pre-admission
clinic
× × Nurses
Not mentioned Lifestyle & bladder
habits information
Telephone survey at 2
weeks and 3 months by
senior nurses
Porru et
al.
(2001)
Pre-op
Initial visit
before surgery
Pre-op
Modified
Oxford scale
Before &
weekly for 4
weeks after
TURP
One urologist
for assessment.
Training by
physiotherapists
Individual
pre-op session
Verbal and
written
× PFM strength weekly
for 4 weeks
Tibaek et
al.
(2007)
Pre-op
Pre-op
Modified
Oxford scale
Before &
weekly for 4
weeks after
TURP
One
physiotherapists
teaching and
assessment
1 individual session
& 3 group
treatments sessions
weekly for 4 weeks,
each one hour
Verbal and
written
× PFM strength weekly
for 4 weeks
97
8.2 What is the suggested content of the PFMT regime?
PFMT content Duration Frequency/
Day
Slow/ strong
contractions
3 positions
(lying,
sitting &
standing)
Knack Tighten the PFM
strongly after
voiding urine
Bladder
training
Lifestyle
leaflet
Chang, et
al. (1998)
- 3-4 sessions of 30 exercises each daily 4 weeks 3-4 times 10 × × × × ×
Glazener
et al.
(2011a)
- Three maximum strength contractions with a
10-second break between each one.
- Target of duration of each contraction up to
maximum of 10 seconds.
12 months 2 times 3
Hou et al.
(2013)
- 5 minutes (contracts 5 seconds & relax 10
seconds) per one single PFE,
12 weeks 3 times ? × × × × ×
Ip (2004) - 5 slow contractions, relax, count for 5,
repeat 6 times in a row
12 weeks 6 times 5 × × ×
Porru et al.
(2001)
- 45 times a day and divided into 3 session of
15 contractions each
4 weeks 3 times 15 × × × × ×
Tibaek et
al. (2007)
- Strength exercise: maximum contraction
(6 seconds contraction/6 seconds rest).
- Endurance exercise:
(maximum 30 seconds contraction/ 30
seconds rest) for as long a time as possible.
- Repeat 6-10 times in the 3 positions,
4 weeks
1-2 times 6 × × ×
98
8.3 What is the frequency for follow up?
1st
week
2nd
week
3rd
week
4th
week
8th
week
12th
week
(3 months)
Others
Chang, et al. (1998)
Glazener et al. (2011a) 3, 6, 9,12 months
Hou et al. (2013)
Ip (2004)
Porru et al. (2001)
Tibaek et al. (2007)
99
Appendix 9: Summary of Recommendation from Reviewed Studies
Recommendation Grade Reviewed Studies (Level of Evidence)
Chang, et al.
(1998)
(2++)
Glazener et
al. (2011a)
(1++)
Hou et al.
(2013)
(1-)
Ip (2004)
(1-)
Porru et al.
(2001)
(1+)
Tibaek et
al. (2007)
(1+)
1. Assessment and outcome measurements
1.1 Baseline assessment on urinary incontinence and urinary symptoms
should be performed before TURP.
A
1..2 Baseline assessment on the strength of pelvic floor muscle should be
performed before TURP.
A
1.3 General health questionnaires which consist of physical,
psycho-social and emotional dimensions are suggested for assessment
the impact of quality of life related to urinary incontinence.
A
2. Pelvic floor muscle training instruction
2.1 Conduct an individual first teaching session on PFMT by trained
health care professional.
A
2.2 The strength of pelvic floor muscle contraction should be assessed and
taught by digital anal examination with verbal feedback.
A
2.3 Patients should be educated for PFMT as soon as before TURP. A
100
Recommendation (continued) Grade Reviewed Studies (Level of Evidence)
Chang, et al.
(1998)
(2++)
Glazener et
al. (2011a)
(1++)
Hou et al.
(2013)
(1-)
Ip (2004)
(1-)
Porru et al.
(2001)
(1+)
Tibaek et
al. (2007)
(1+)
2.4 Patients should practice PFMT in three positions with 1-6 times per
days and the “knack” at home.
A
3. Patient education tools
3.1 Verbal and written instructions of PFMT should be given to patients
for home practice.
A
3.2 Visual reminder acts as a reminder to practice PFMT at home. C
4. Frequency of follow-up sessions
4.1 After initial PFMT pre-operative teaching session, a reminder session
before discharge and a follow-up at 4th
week after operation are
suggested to monitor patients’ progress.
A
101
Appendix 10: ICIQ-UI Short Form
102
Appendix 11: The Chinese Version of the ICIQ-UI Short Form
103
Appendix 12:
Nurses’ Evaluation Form for Self-perceived Skills and Knowledge and
Satisfaction Levels
Dear Nurses,
Thank you for your participation in the training program: “An evidence-based
pelvic floor muscle training program to reduce urinary incontinence for patients
undergoing transurethral resection of prostate”. Please fill in your feedback below,
your opinion is valuable to us in continuously improving patient care.
Please tick in the appropriate boxes.
1 2 3 4 5
Strongly
disagree
Disagree Neutral Agree Strongly
agree
1. You understand the potential complications
of TURP.
2. You understand the benefits of pelvic floor
muscle training for TURP patients
3. You are clear the selection criteria for
target patients.
4. You are clear about the workflow of the
program.
5. The skills and measuring tools for
evaluation are well understood.
6. You have the skills to conduct the program
and make use of the measuring tools.
7. You understand the importance of
conducting the program with the support of
an evidence-based guideline.
Other comments:
____________________________________________________________________
____________________________________________________________________
Thank You.
104
Appendix 13: A Permission Letter for the use of ICIQ-UI Short Form
105
References
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International Consultation on Incontinence Modular Questionnaire:
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Abrams, P., Andersson, K. E., Brider, L., Brubaker, L., Cardozo, L., Chapple, C.,
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C., Fry, C., Hanno, P., Hay Smith, J., Herchorn, S., Hosker, G., Kelleher, C.,
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Tubaro, A., Vodusek, D. B., Wein, A., & Wyndaele, J. J. (2009). 4th
International
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urinary incontinence, pelvic organ prolapse and faecal incontinence. Retrieved
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Bauer, R. M., Bastian, P. J., Gozzi, C. & Stief, C. G. (2009). Postprostatectomy
incontinence: all about diagnosis and management. European Urology, 55,
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Chang, P. L., Tsai, L. H., Huang, S. T., Wang, T. M., Hsieh, M. L. & Tsui, K. H. (1998).
The early effect of the pelvic floor muscle exercise after transurethral
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