Long-term effectiveness and safety of open Burch colposuspension versus retropubic midurethral sling for stress urinary incontinence – results from a large comparative study

Background There are few adequately powered long-term trials comparing midurethral sling (MUS) and Burch colposuspension (BC). Recent concerns about synthetic mesh with new stringent clinical and research governance support the need for evidence to inform shared decision making. Objective To compare long-term outcomes of open Burch colposuspension (BC) to the retropubic midurethral sling (RP-MUS). Study design A matched cohort study of 1,344 women with urodynamic stress incontinence (without intrinsic sphincter deficiency) who underwent surgery for stress urinary incontinence (SUI). Women had either open Burch colposuspension (BC) or the retropubic midurethral sling (RP-MUS), from January 2000 to June 2018, in a tertiary centre. Follow-up was by chart review and one-time phone follow-up until 2019, using a dedicated database. Primary outcomes were presence or absence of SUI 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 1,344 women who had either BC (336) or RP-MUS (1008). Mean follow-up was 13.1 years for BC and 10.1 years for RP-MUS. In the BC group, 83.0% of patients (279/336) reported no ongoing SUI at the time of the latest follow-up, versus 857/1008 (85.0%) in the RP-MUS group (p=0.38). Success in terms of the latest reported International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) (defined as ICIQ-UI SF score ≤ 6 ) where this data was available, were similar within both groups - 76.0% (158/208 where this was available) in BC versus 72.1% (437/606 where this was available) in RP-MUS, p=0.32). Where this information was available, success defined by a Patient Global Impression of Improvement (PGI-I) of “very much improved” and “much improved” was similar between BC and RP-MUS groups (84.1% (243/289) versus 82.0% (651/794), p=0.88). Where data was available,88.1% (178/202) of women in the BC group said they were very likely to recommend the surgery to family or a friend versus 85.0% (580/682) in RP-MUS (p=0.30). Overall, 3.6% needed repeat incontinence procedures (13 in BC group (3.8%) versus 35 in RP-MUS group (3.5%), (p=0.73)). Incidence of mesh exposure was 1.0 %. One BC patient had a suture in the bladder during follow-up. Five patients have reported long-standing pain across the study population. Overall, 51 women reported new-onset overactive bladder symptoms on follow-up: 10/336 (3.0%) had BC and 41/1008 (4.1%) had RP-MUS (p = 0.41). Need for future prolapse surgery per index procedure was 3.3% following BC versus 1.1% post RP-MUS (p=0.01). Nine out of the 11 patients who needed a prolapse repair following BC required a posterior repair. Incidence of long-term severe voiding difficulty needing self-catheterization was similar in both groups (0.3% in BC, 0.5 % in RP-MUS group, p=1.00). Conclusions This study shows no difference in success, patient satisfaction, or complications between BC and RP-MUS, although the risk of posterior compartment prolapse operations after BC is increased. Re-operation rates for incontinence were similar in both groups. Chronic pain was a rare outcome.