lima jpc, pompeo acl, bezerra ca
TRANSCRIPT
STUDY DESIGN, MATERIALS AND METHODS
SUB URETHRAL SLING FOR MALE URINARY INCONTINENCE: RANDOMIZED CLINIC TRIAL OF TWO SLINGS
Lima JPC, Pompeo ACL, Bezerra CA
Comparison of Argus® sling and AdVance® sling for male urinary
incontinence in the mid-term (12 months) follow up.
HYPOTHESIS / AIMS OF STUDY
From December 2010 to December 2011, 42 male patients with urinary
incontinence were recruited and 22 were randomized through computer random
table to sub urethral sling with Argus® (Promedon) or AdVance® (A.M.S.). All
patients were evaluated, before surgery, with multichannel urodynamic study, 24
hour pad test, QoL questionnaires (ICIQ – SF), voiding diary and clinical
examination including insertion of a 14 FR catheter to rule out urethral stenosis. All
patients had minimum six months after surgery which caused incontinence.
Patients with neurologic conditions, detrusor overactivity and urethral stenosis
were excluded. Protocol was approved by institution’s Ethical Committee and
patients agreed to sign informed consent. Surgery was performed as
recommended by manufacturers and follow up was planned in 7 days and 1, 6, 12
and 18 months post operatory. During follow up patients were submitted to pad
tests, voiding diaries and QoL questionnaires. Patients with urinary leaks after
Argus® were submitted to re-adjust of sling and followed as others. Success were
defined as cured (no leaks in pad test or voiding diary and 80% reduction in QoL
scores), improved (at least 50% reduction in leaks episodes or pad test weight and
reduction of more than 50% in QoL scores) or failed (none of the previous
conditions). Minimum 12 months follow up is presented. Results were analysed
statistically with Fisher’s exact test, Kolmogorov-Smirnov test, Friedman’s non
parametric test or Mann-Whitney test, according to the type of variable studied.
Patients were comparable between age, time after surgery which cause
incontinence, risk of cancer return according to Damico’s criteria, intensity of
incontinence, etc. Two patients (one in each group) did not complete 12 month
follow up (both died for other cause not related to surgery, cancer or incontinence).
The most important results are presented in the following table. Only one patient
was cured in the Advance group and two patients were cured in the Argus group. In
regard to improvement, both slings resulted in best QoL (see table). But in pad
tests and pad changes, Argus group provided better results. When we looked up
over incontinence episodes on voiding diaries both groups were statistically similar
with a better result favouring Argus group, where two patients were submitted to
readjustment. One patient were submitted to explantation of sling due to non-
treatable perineal pain. There were no other complications.
Variable Surgery Follow up n Medium sd min max p*
QoL
Advance
Baseline 10 19,10 1,97 16,00 21,00
0,004 6 m. 10 12,00 8,41 0,00 21,00
12 m. 10 12,90 7,61 0,00 21,00
Argus
Baseline 10 17,80 3,39 11,00 21,00
0,015 6 m. 10 9,10 7,98 0,00 21,00
12 m. 10 10,20 6,99 0,00 21,00
PAD
test
Advance
Baseline 10 619,30 445,46 50,00 1334,00
0,110 6 m. 10 480,10 726,45 0,00 1913,00
12 m. 10 284,40 331,04 0,00 880,00
Argus
Baseline 10 686,20 721,06 100,00 2550,00
0,017 6 m. 10 173,00 297,36 0,00 893,00
12 m. 10 70,00 110,64 0,00 343,00
Incontinent
Episodes
Advance
Baseline 10 3,25 3,04 0,00 7,30
0,430 6 m. 10 1,86 3,32 0,00 9,00
12 m. 10 6,89 8,35 0,00 20,00
Argus
Baseline 10 4,10 3,70 0,00 10,00
0,159 6 m. 10 1,56 2,25 0,00 7,00
12 m. 10 1,19 1,93 0,00 5,00
Pad
changes
Advance
Baseline 10 3,91 2,73 2,00 11,00
6 m. 10 3,13 4,05 0,00 12,00 0,349
12 m. 10 2,55 3,51 0,00 11,60
Argus
Baseline 10 4,17 2,38 1,30 9,00
6 m. 10 1,90 2,81 0,00 8,00 0,013
12 m. 10 1,69 2,30 0,00 7,30
(*) Friedman’s non parametric test
Results for several variables
Results according do DAMICO classification of risk
Our results show that both slings improve QoL in male patients with urinary
incontinence. Argus were better than AdVance in reduction of pad tests weight and
pad changes and tended to be better in reduction of incontinence episodes. This
suggests that QoL does not necessarily reflect objective improvement and authors
should look forward seeing closer the effects of this kind of surgery. In addition we
observed that results were similar between patients with mild/moderate
incontinence severity (< 400 ml/24h) in comparison with severe incontinence (> =
400 ml/24h). This suggests that slings may be tried in all patients before artificial
urinary sphincter. Finally, we also observed that patients with high risk of
recurrence, according to D'Amico's criteria have poor results. In spite this was
thought before, this is the first time it is demonstrated with data. We should
address these new insights in future research on this field
Argus tended to be better than Advance in male urinary incontinence in the mid-
term follow up.
Variable Risk Follow up n Medium sd min max p* min
QoL
low
Baseline 5 18,40 2,51 16,00 21,00 18,00
0,011 6 m. 5 9,40 6,80 0,00 17,00 12,00
12 m. 5 10,60 7,13 0,00 18,00 14,00
Medium
Baseline 9 17,44 3,24 11,00 21,00 17,00
0,013 6 m. 9 6,33 7,47 0,00 21,00 4,00
12 m. 9 8,56 6,33 0,00 21,00 8,00
High
Baseline 6 20,00 1,67 17,00 21,00 21,00
0,178 6 m. 6 17,83 5,19 8,00 21,00 20,50
12 m. 6 16,83 6,65 6,00 21,00 21,00
PAD test
low
Baseline 5 698,60 1039,51 100,00 2550,00 270,00
0,104 6 m. 5 139,20 135,33 0,00 300,00 150,00
12 m. 5 142,40 123,17 0,00 300,00 138,00
Medium
Baseline 9 613,44 393,15 100,00 1334,00 645,00
0,003 6 m. 9 226,00 633,27 0,00 1913,00 0,00
12 m. 9 86,78 231,63 0,00 703,00 0,00
High
Baseline 6 673,50 424,70 50,00 1200,00 743,50
0,738 6 m. 6 633,50 617,03 0,00 1630,00 629,00
12 m. 6 341,83 344,70 0,00 880,00 241,50
(*) Friedman’s non parametric test
RESULTS
INTERPRETATION OF RESULTS
CONCLUDING MESSAGE