Download - PowerPoint Presentation - UAB...• Older women with medical co-morbidities Manchester Procedure • Only RCT, Ünlübiligin et al, 2013 • Primary outcome, prolapse recurrence 5

1/2/2019

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Evidence-Based Review of Transvaginal

Hysteropexy for Uterovaginal Prolapse

Holly E. Richter, PhD, MD

J Marion Sims Endowed Chair

Professor Obstetrics and Gynecology, Urology and Geriatrics

Division of Urogynecology and Pelvic Reconstructive Surgery

Department of Obstetrics and Gynecology

February 21 , 2019

Disclosures

• Pelvalon-consultant; research funding,

device study, non-surgical treatment FI

• Renovia-consultant; research funding non-

surgical treatment SUI

• Bluewind-consultant, refractory UUI

• UpToDate

• Travel with IUJ and Obstet Gynecol, editor

• NIA-research funding

• NICHD, NIDDK-research funding

• PCORI-research funding

No Conflict of Interest

Objectives

• Discuss hysteropexy indications

-Patient selection

-Contraindications

• To summarize existing evidence regarding

objective and subjective outcomes of native

tissue hysteropexy techniques vs vaginal

hysterectomy for uterovaginal prolapse

• To present results of most recent RCT of mesh

hysteropexy/repairs to TVH/repairs for

uterovaginal prolapse: Study of Uterine Prolapse

Procedures Randomized Trial (SUPeR)

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Do We Have to Perform a

Hysterectomy?• Uterus not the cause

• Hysterectomy routinely performed - improve support

• True?

• Standard of care?

• Limited exposure to hysteropexy – residency/

fellowship

• Women request hysteropexy - unique reasons or

preferences/clinical situations

• An increasing number of studies are

investigating uterine sparing procedures with an

emphasis on:

-efficacy

-safety

-improved quality of life

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Outcomes of NT Hysteropexy vs Hysterectomy

• Recent systematic review addressing this issue:*

-similar short-term efficacy, 3 years (apical recurrence, RR 2.22, 95% CI, 0.80 to 6.17; anterior, RR 0.86, 95% CI, 0.48 to 1.55; posterior RR 0.79, 95% CI, 0.79 to 2.03

-decreased blood loss (-89.9 mL, 95% CI, -14.9 to -165.0 mL)

-decreased operative time (-17.5 min, 95% CI, -6.0 to -29.2 min)

-satisfaction (RR, 1.07, 95% CI, 0.38 to 2.99)

*Meriwether et al, 2018

Patient Opinions

• 220 referrals prolapse

• 127 (57.5%) response

• 60% choose hysteropexy if equal efficacy

• Hysterectomy: worsen mood, relationship, QOL,

femininity, body image, lubrication, sex drive, weight

gain

• Most important factors:

• Doctor’s opinion

• Risk of surgical complications

• Risk of malignancy

Frick AC et al. Attitudes toward hysterectomy in women undergoing evaluation for uterovaginalprolapse. Female Pelvic Med Reconstr Surg 2013;19:103-9.

So why am I talking about this?

• Do I have something against vaginal

hysterectomy?

• Am I on a crusade to “SAVE THE UTERUS”?

• Do I want to have an evidence-based discussion

with my patients on all surgical options for the

treatment of uterovaginal prolapse?

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Why Leave the Uterus?

• Desires future fertility

• Belief that the uterus affects sexual

function or sense of identity

• Concern about risks of hysterectomy

Hysterectomy / Ovarian Function

• Prospective cohort, age 30-47

• Hyst no BSO (406) vs Controls (465)

• Annual blood samples x 5 yrs

• Ovarian failure: FSH ≥ 40

• Hyst: HR = 1.92 (1.29-2.86)

• Hyst only: HR = 1.74 (1.14-2.65)

• Hyst + USO: HR = 2.93 (1.57-5.49)

• 14.8% Hyst vs 8% controls ovarian failure >4 yrs

Moorman PG. Effect of hysterectomy with ovarian preservation on ovarian function. ObstetGynecol 2011;118:1271-9.

Contraindications Uterine Conservation

• Uterine abnormalities

• Fibroids, adenomyosis, endometrial pathology

• Current/recent cervical dysplasia

• Abnormal menses

• PMB

• Genetic risks

• BRCA 1 & 2, HNPCC

• Tamoxifen therapy

• Unable to comply with routine surveillance

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Types of Hysteropexy

• Vaginal

– Manchester

– Uterosacral

hysteropexy

– Sacrospinous

hysteropexy

– Vaginal Mesh

hysteropexy

• Abdominal

– Sacral hysteropexy

• Laparotomy

• Laparoscopy

• Robotic

– Laparoscopic

uterosacral

hysteropexy

Types of Hysteropexy

• Vaginal

– Manchester

– Uterosacral

hysteropexy

– Sacrospinous

hysteropexy

– Vaginal Mesh

hysteropexy

• Abdominal

– Sacral hysteropexy

• Laparotomy

• Laparoscopy

• Robotic

– Laparoscopic

uterosacral

hysteropexy

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Manchester Procedure

• First described in 1888 by McDonald and

modified by Fothergill, 1921

• Primarily a procedure for cervical elongation

(cervical amputation followed by midline cardinal

and uterosacral ligament plication)

• Premenopausal women to maintain fertility

• Older women with medical co-morbidities


• Only RCT, Ünlübiligin et al, 2013

• Primary outcome, prolapse recurrence 5 years

defined as point C>-1

• 49 MP vs 45 TVH

• No difference between groups at baseline, point C

(0.77±0.75, MP vs 1.31±0.51, TVH p=0.062)

• No difference 5 years, (-6.3±0.91 MP vs -6.0±0.97

TVH, p=0.13)

• MP, shorter operative time, p=0.003 and shorter

hospital stay, p=0.042)

Manchester Procedure vs TVHStudy Design Surgeries Number

of Patients

Success

Rate

Follow

Up

Success

Definition

Outcome

measures

Thys et al

(2011)

Retrospective

matched cohort

MP vs. TVH

with USLS

MP: 98

TVH: 98

MP: 81%

TVH: 82%

Median 6

years

No

recurrence of prolapse

on exam

(unclear)

QOL,

morbidity, POP recurrence

Iliev (2014) Retrospective

matched cohort

MP vs. TVH MP: 33

TVH: 33

MP: 90%

TVH: 85%

1 year No

retreatment of prolapse

(unclear)

POP

recurrence, re-treatment,

complications,

operative time,

EBL

Kalogirou

(1996)

Retrospective

cohort

MP vs. TVH

with AR

MP: 190

TVH: 231

MP: MD

TVH: MD

3 years No

anatomic outcomes

Operative time,

EBL, hospital stay

De Boer et

al (2009)

Retrospective

cohort

MP vs. TVH

with USLS

MP: 81

TVH: 75

MP: 100%

TVH: 96%

1 year POPQ point

C (Stage 1 or less)

POPQ points,

operative time, EBL, hospital

stay

Thomas et

al (1995)

Retrospective

cohort

MP vs. TVH MP: 88

TVH: 105

MP: MD

TVH: MD

No follow

up

No

anatomic outcomes

Operative time,

EBL, hospital stay

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Skiadas CC, et al, The Manchester-Fothergill Procedure as a Fertility Sparing Alternative

for Pelvic Organ Prolapse in Young Women. J Pediatr Adolesc Gynecol 2006;19:89-93.



for Pelvic Organ Prolapse in Young Women. J Pediatr Adolesc Gynecol 2006;19:89-93.



for Pelvic Organ Prolapse in Young Women. J Pediatr Adolesc Gynecol 2006;19:89-93


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Uterosacral Hysteropexy

• No RCTs comparing outcomes of USH and TVH

• Romanzi et al, 2012 retrospective cohort

• Primary outcome ≥Grade 2 prolapse any

compartment; N=100 each group

• No difference in baseline anterior or apical

compartments (point C, 2.91±0.91, USH vs

2.84±1.02, TVH, p=0.82)

• No difference in 2 year recurrence-free durability

apex: (96%, 95% CI, 87.7%, 98.8%), p=0.90

Uterosacral Hysteropexy

Sacrospinous Hysteropexy

• Best studied vaginal uterine-sparing procedure

• SSLF of the vaginal cuff first described in 1950’s

• Richardson et al, reported a case series of 5

patients in 1989

Richardson, Scotti, Ostergard, JRM, 1989

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Richardson DA, et al. Surgical Management of Uterine Prolapse in Young Women. J

Reprod Med 1989;34:388-92.


• Unilateral • Bilateral

Kovac SR, Cruikshank SH. Successful pregnancies and vaginal deliveries after

sacrospinous uterosacral fixation in five of nineteen patients. Am J Obstet Gynecol

1993;168:1778-86.


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Cohort Studies SSH vs HysterectomyStudy Design Surgery Number of

Patients

Success Rate Follow Up Success Definition

Hefni et al

(2003)24

Prospective

cohort

SSH vs TVH

with SSLF

SSH: 61

TVH: 48

SSH: 94%

TVH: 96%

33 months Apex greater than

6cm from hymen on valsalva

Maher et al

(2001)25

Retrospective

cohort

SSH vs TVH

with SSLF

SSH: 34

TVH: 36

SSH: 74%

TVH: 72%

26 months Apex above ½ TVL,

no repeat surgery

Van

Brummen (2003)26

Retrospective

cohort

SSH vs TVH

with USLS

SSH: 44

TVH: 30

SSH: 89%

TVH: 93%

19 months Baden-Walker grade

1 or less of any compartment

Lo et al

(2015)27

Retrospective

cohort

SSH vs TVH

with SSLF

SSH: 26

TVH: 120

SSH: 50%

TVH: 72%

86 months POPQ Stage 1 or

less


• Dietz 2010

• RCT SSH (n=37) vs. TVH, USLS (n=34)

• Apical recurrences: 21% vs. 3%, p=0.03

• 3 SSHP stage 4 prolapse – all failed

• Subjective: both improved

• Shorter LOS, quicker return work, longer TVL

• Anterior prolapse (51% vs. 64%)

Dietz V, et al. One-year follow-up after sacrospinous hysteropexy and vaginal

hysterectomy for uterine descent: a randomized study. Int Urogynecol J 2010;21: 209-16


• Detollenaere, et al, 2015

• Non-inferiority RCT

• N=103, SSH vs N=105, TVH/USLS

• 1° outcome-composite at 12 months (apical <

Stage 2, no bothersome symptoms and no re-op)

• Success: 100% SSH vs 96% TVH, (-3.9, 95% CI,

-8.6, 0.7)

• Functional and QOL similar

• AEs: Buttock pain, 9% vs 0%

Detollenaere et al, BMJ, 2015

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• Jeng 2005

• RCT, SSH vs TVH/SSLF

• No difference sexual function (FSFI-7)

• Low rate dyspareunia (5%)

• No anatomic outcomes

• Transient buttock pain (15%)

Jeng CJ, et al. Sexual functioning after vaginal hysterectomy or transvaginal sacrospinous uterine suspension for uterine prolapse: a comparison. J Reprod Med 2005; 50:669-74

Vaginal Mesh Hysteropexy

Vaginal Mesh Hysteropexy

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UpholdTM Hysteropexy

UpholdTM Hysteropexy

• 115 total, 53 HP

• Follow-up 12 mo

• POP-Q Preop Postop p

• Ba 0.9 -2.4 <0.01

• C -2.4 -7.7 <0.01

• Bp -0.1 -2.6 <0.01

• 1(1.9%) apical recurrence, no anterior (POPQ ≤ 1)

• 1 (1.9%) mesh exposure, no pain/dyspareunia

Vu MK, et al. Int Urogynecol J, 2012

Study of Uterine Prolapse Procedures

Randomized Trial (SUPeR), NCT01802281

• RCT : Apical Uphold Mesh Hysteropexy/Repairs vs TVH/Repairs

• Primary Outcome 36 months, survival models

• Composite outcome: no prolapse symptoms, no prolapse beyond the hymen, no retreatment

• N=175 total, mean age 65.9±0.6

• No difference in primary outcome, aHR 0.65, 95% CI 0.39, 1.06

• Operative times significantly shorter in HSP group, 111.5±4.2 min vs 156.7±4.7 min, p<0.0001

• POPQ point Ba, HSP -1.2±0.1 vs TVH 0.7±0.2, p=0.03

• Mesh exposure 8%

• Functional and QOL similar

Nager et al, FPMRS 2016

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Pregnancy and Hysteropexy

• Pessary first line

• Limited information counselling patients desiring

future pregnancy

• No data regarding which hysteropexy better for:

• Fertility

• Pregnancy & delivery

• Postpartum support & durabilityCavkaytar et al, 2017

How Do I Choose a Vaginal Uterine-Sparing

Approach?• Desires future fertility

• Vaginal SSH

• Completed childbearing and sexually active

• Vaginal SSH, TV mesh hysteropexy

• Done with childbearing and not sexually active

• LeFort Colpocleisis

• Other obliterative approach (SSH/obliterative

closure)

https://augs.confex.com/data/abstract/augs/2018/Paper_2081_abstract_999_0.png

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Conclusion• Uterine conservation is a reasonable option and

would discuss all options with patients

• Proper patient selection

• Limited long-term data

• Subsequent hysterectomy may be challenging

• Currently not standard of care-increasingly being

offered and performed

• Better results: data would support mesh anterior

compartment; need longer term outcomes of RCTs

• Risk failure: Stage 4/cervical elongation

For more information on active

studies

Please visit our Urogynecology table:

Kathy Carter, RN, BSN

Jill Hyde, RN, BSN

Robin Willingham, RN, BSN

Call: 205-934-5498

Select References• Korbly NB, Kassis NC, Good MM, et al. Patient preferences for uterine preservation

and hysterectomy in women with pelvic organ prolapse. Am J Obstet Gynecol

2013;209:470.e1-6.

• Madsen AM, Raker C, Sung VW. Trends in hysteropexy and apical support for

uterovaginal prolapse in the United States from 2002 to 2012. Female Pelvic Med

Reconstr Surg 2017;23: 365-371

• Meriwether KV, Antosh DD, Olivera et al. Uterine preservation vs hysterectomy in

pelvic organ prolapse surgery: a systematic review with meta-analysis and clinical

practice guidelines. Am J Obstet Gynecol 2018; 219(2):129-146

• Ünlübilgin E, Sivaslioglu AA, Ilhan TT, Kumtepe Y, Dölen I. Which one is the

appropriate approach for uterine prolapse: Manchester procedure or vaginal

hysterectomy? Turkiye Klinik J Med Sci 2013;33:321-5

• Romanzi, L.J., Tyagi, R. Hysteropexy compared to hysterectomy for uterine prolapse

surgery: does durability differ?. Int Urogynecol J. 2012;23:625–631

• Richardson DA, Scotti RJ, Ostergard DR. Surgical management of uterine prolapse in

young women. J Reproduc Med. 1989 Jun;34(6):388-92

• Dietz, V., van der Vaart, C.H., van der Graaf, Y., Heintz, P., Schraffordt Koops, S.E.

One-year follow-up after sacrospinous hysteropexy and vaginal hysterectomy for

uterine descent: a randomized study. Int Urogynecol J. 2010;21:209–216

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Select References• Detollenaere, R.J., den Boon, J., Stekelenburg, J. et al, Sacrospinous hysteropexy vs vaginal

hysterectomy with suspension of the uterosacral ligaments in women with uterine prolapse stage 2 or higher: multicentre randomised non-inferiority trial. BMJ. 2015;351:h3717

• Jeng, C.J., Yang, Y.C., Tzeng, C.R., Shen, J., Wang, L.R. Sexual functioning after vaginal

hysterectomy or transvaginal sacrospinous uterine suspension for uterine prolapse: a comparison.

J Reprod Med. 2005;50:669–674

• Maher, C.F., Cary, M.P., Slack, M.C., Murray, C.J., Milligan, M., Schluter, P. Uterine preservation or

hysterectomy at sacrospinous colpopexy for uterovaginal prolapse?. Int Urogynecol J Pelvic Floor

Dysfunct. 2001;12:381–384 (discussion 384-5)

• Lo, T.S., Pue, L.B., Hung, T.H., Wu, P.Y., Tan, Y.L. Long-term outcome of native tissue

reconstructive vaginal surgery for advanced pelvic organ prolapse at 86 months: Hysterectomy vs

hysteropexy. J Obstet Gynaecol Res. 2015;41:1099–1107

• Maher, C., Baessler, K., Glazener, C.M., Adams, E.J., Hagen, S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn. 2008;27:3–12

• Cavkaytar S, Kokanalı MK, Tasdemir U, Doganay M, Aksakal O. Pregnancy outcomes after

transvaginal sacrospinous hysteropexy. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:204-207

• Nager CW, Zyczynski H, Rogers RG, Barber MD, Richter HE, Visco AG, Rardin CR, Harvie H,

Wallace D, Meikle SF; Pelvic Floor Disorders Network. The Design of a Randomized Trial of

Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault

Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures

Randomized Trial). Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):182-9

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Download - PowerPoint Presentation - UAB...• Older women with medical co-morbidities Manchester Procedure • Only RCT, Ünlübiligin et al, 2013 • Primary outcome, prolapse recurrence 5

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