Original Research
Gynecology
Long-term effectiveness and safety of open Burch colposuspension vs retropubic midurethral sling for stress urinary incontinence—results from a large comparative study

Interim findings of this study were presented as an oral poster at the 24th Joint Annual Scientific Meeting of the American Urogynecologic Society and the International Urogynecological Association, Nashville, TN, September 24–28, 2019.
https://doi.org/10.1016/j.ajog.2020.11.043Get rights and content

Background

There are few adequately powered long-term trials comparing midurethral sling and Burch colposuspension. Recent concerns about synthetic mesh with new stringent clinical and research governance support the need for evidence to facilitate shared decision making.

Objective

This study aimed to compare long-term outcomes of open Burch colposuspension with the retropubic midurethral sling.

Study Design

A matched cohort study of 1344 women with urodynamic stress incontinence (without intrinsic sphincter deficiency) who underwent surgery for stress urinary incontinence. Women had either open Burch colposuspension or the retropubic midurethral sling, from January 2000 to June 2018, in a tertiary center. Follow-up was by chart review and one-time phone follow-up until 2019, using a dedicated database. Primary outcomes were the presence or absence of stress urinary incontinence on follow-up, the success of index surgery based on response to validated questionnaires of patient-reported outcomes, and retreatment rates. Secondary outcomes are described below. Matching (1:3) was done at baseline to avoid confounding.

Results

The study included 1344 women who had either Burch colposuspension (336) or retropubic midurethral sling (1008). Mean follow-up was 13.1 years for Burch colposuspension and 10.1 years for retropubic midurethral sling. In the Burch colposuspension group, 83.0% of patients (279 of 336) reported no ongoing stress urinary incontinence at the time of the latest follow-up vs 85.0% (857 of 1008) in the retropubic midurethral sling group (P=.38). Success in terms of the latest reported International Consultation on Incontinence Questionnaire—Urinary Incontinence Short Form (defined as International Consultation on Incontinence Questionnaire—Urinary Incontinence Short Form score of ≤6) where these data were available were similar within both groups: 76.0% (158 of 208 where this was available) in Burch colposuspension vs 72.1% (437 of 606 where this was available) in retropubic midurethral sling (P=.32). Where this information was available, success defined by a Patient Global Impression of Improvement of “very much improved” and “much improved” was similar between Burch colposuspension and retropubic midurethral sling groups (84.1% [243 of 289] vs 82.0% [651 of 794]; P=.88). Where data were available, 88.1% of women (178 of 202) in the Burch colposuspension group said they were very likely to recommend the surgery to family or a friend vs 85.0% (580 of 682) in retropubic midurethral sling (P=.30).Overall, 3.6% needed repeat incontinence procedures (13 in Burch colposuspension group [3.8%] vs 35 in retropubic midurethral sling group [3.5%]; P=.73). The incidence of mesh exposure was 1.0 %. Notably, 1 Burch colposuspension patient had a suture in the bladder during follow-up; 5 patients have reported long-standing pain across the study population. Overall, 51 women reported new-onset overactive bladder symptoms on follow-up: 10 of 336 (3.0%) had Burch colposuspension and 41 of 1008 (4.1%) had retropubic midurethral sling (P=.41). The need for future prolapse surgery per index procedure was 3.3% after Burch colposuspension vs 1.1% postretropubic midurethral sling (P=.01). Moreover, 9 of the 11 patients who needed a prolapse repair after Burch colposuspension required a posterior repair. The incidence of long-term severe voiding difficulty needing self-catheterization was similar in both groups (0.3% in Burch colposuspension and 0.5 % in retropubic midurethral sling group; P=1.00).

Conclusion

This study shows no difference in success, patient satisfaction, or complications between Burch colposuspension and retropubic midurethral sling, although the risk of posterior compartment prolapse operations after Burch colposuspension is increased. Reoperation rates for incontinence were similar in both groups. Chronic pain was a rare outcome.

Introduction

The current lifetime risk of requiring surgery for stress urinary incontinence (SUI) in the United States is approximately 13.5%.1, 2, 3 The Burch colposuspension (BC) was first described for the surgical management of SUI by John C. Burch in 19614 and is performed through a low transverse incision in the abdomen. It involves the placement of 2 to 3 permanent sutures suspending the vagina to the Cooper’s ligament (iliopectineal ligament) bilaterally to support the urethra and bladder neck. Success ranges from 85% to 90% (1 year postoperatively) to 70% (5 years postoperatively).5,6 Although originally described as an open abdominal procedure, this can also be performed laparoscopically with equally good results.7,8 Up until the 1990s, the BC was considered the gold standard surgery for SUI and accounted for more than 80% of SUI operations.

AJOG at a Glance

Although there have been long-term reports of open Burch colposuspension and midurethral sling outcomes separately, there are few published comparative reports of long-term outcomes of Burch colposuspension and midurethral sling.

This long-term comparison of open Burch colposuspension and retropubic midurethral sling indicates both procedures are safe and have the same levels of subjectively reported success.

Although the midurethral sling is minimally invasive, long-term satisfaction rates were similar for both. Reoperation rates for incontinence were identical in both groups.

Midurethral slings (MUSs) were developed in the 1990s based on the work of Petros and Ulmsten9 in developing the tension-free vaginal tape (TVT), and the transobturator sling followed this, which was developed in 2001 by Delorme.10 This innovation revolutionized surgery for SUI owing to the minimally invasive nature and hence could be performed as a day procedure with local anesthesia.9,10 The retropubic MUS (RP-MUS) proved itself to be a robust alternative to BC with subjective cure rates of 85% at 4 years,10,11 with a low incidence of complications including mesh exposure and chronic pain. Although these complications are uncommon, they can cause considerable morbidity and impact on the quality of life. This has led to the MUS being the subject of numerous lawsuits with the subsequent withdrawal of many MUS products from the market after multimillion-dollar payouts for class actions.12, 13, 14, 15 Regulatory authorities have created new and more robust guidelines for the long-term follow-up of incontinence slings and tighter regulation of innovation related to incontinence surgery.16, 17, 18 This has caused renewed interest in surgical alternatives to the MUS, including BC, autologous fascial sling (AFS) or pubovaginal sling, and urethral bulking agents.19,20

The rapid replacement of BC by MUS as the first choice of surgery for SUI by surgeons and patients has meant that, although there have been long-term reports of BC and MUS outcomes separately, there are few published comparative reports of long-term outcomes of BC and MUS.21, 22, 23 This study aims to fill this research gap by comparing the long-term results of BC with the RP-MUS.

Section snippets

Materials and Methods

This is a matched cohort study comprising of 1344 women with SUI proven on urodynamic studies who had surgery for SUI by either open abdominal BC or RP-MUS (alone or concomitantly with surgery for prolapse) in the period from January 2000 to June 2018 in our Department of Urogynecology and entered in a dedicated electronic database. The demographic, clinical, and follow-up and questionnaire (as part of follow-up) data were entered retrospectively through regular chart reviews. A one-time

Results

The study included 1344 women. The index procedure was BC in 336 and RP-MUS in 1008. The demographic and clinical data are presented in Table 1. The mean follow-up period was 13.1 years for BC and 10.1 years for RP-MUS. For 412 patients (30.6%), we have one-time follow-up data from the round of phone call and mail-in questionnaires performed in 2019 (152 BCs [45.2%] and 260 RP-MUSs [25.8%]). Concomitant procedures were performed in 320 patients (23.8%) (Table 1). For the remaining subjects, the

Principal findings

Our study found high long-term success and low complication rates for both BC and RP-MUS. Long-term patient satisfaction was similar for both approaches. Although the MUS is more minimally invasive,23 patients who had BC were equally satisfied in the long-term with a large majority indicating they would be happy to refer their family or friends for this procedure.

Results

One long-term study of TVT at 17-year follow-up indicated more than 90% of women were objectively continent and 87% were subjectively

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      Citation Excerpt :

      Posterior repair and prior SUI surgery, but not concomitant SUI surgery, were strongly associated with baseline and de novo dyspareunia in our study. Even though it has been reported that chronic pain after SUI surgery is a rare outcome [36], dyspareunia, worsening of orgasm and satisfaction, and sling revisions because of pain have been reported in several studies comparing SUI procedures [37–40]. Unfortunately, we lack sufficient data on the type of prior SUI surgery to analyze this further.

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    The authors report no conflict of interest.

    The study did not receive any funding from any sources.

    Cite this article as: Karmakar D, Dwyer PL, Murray C, et al. Long-term effectiveness and safety of open Burch colposuspension vs retropubic midurethral sling for stress urinary incontinence—results from a large comparative study. Am J Obstet Gynecol 2021;224:593.e1-8.

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