New England Journal of Medicine · 2012
OPUSOutcomes following vaginal Prolapse repair and mid-Urethral Sling

A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair

Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, et al. · Pelvic Floor Disorders Network
DOI: 10.1056/NEJMoa1111967 · ClinicalTrials.gov NCT00460434
Design
Sham-Controlled RCT
Patients
337
Sites
7
Follow-up
12 months
Completion
97%
Intervention · n = 165
Prophylactic TVT Sling
Retropubic midurethral sling (Gynecare TVT) placed during vaginal prolapse repair
Control · n = 172
Sham Incisions
Two 1-cm suprapubic incisions mimicking trocar sites — no sling placed
6.3
Number Needed to Treat (12 months) For every 6–7 women who receive a prophylactic sling at the time of prolapse repair, one case of urinary incontinence is prevented at 1 year.
Primary Outcome — Urinary Incontinence Rate
3 Months
Sling
23.6%
Sham
49.4%
P < 0.001 · NNT 3.9
12 Months
Sling
27.3%
Sham
43.0%
P = 0.002 · NNT 6.3
Preoperative stress test did not determine benefit. Sling reduced incontinence regardless of whether the prolapse-reduction cough stress test was positive or negative. Only 33.5% of women had a positive test preoperatively.
Safety — Higher Adverse Events with Sling
Bladder Perforation
6.7% vs 0% (P < 0.01)
UTI
31.0% vs 18.3% (P = 0.008)
Major Bleeding
3.1% vs 0% (P = 0.03)
Voiding Dysfunction at 6 wk
3.7% vs 0% (P = 0.01)
No Mesh Erosions
0% in both groups — no sling-related mesh complications observed
Take-Home Message

In women without stress incontinence symptoms undergoing vaginal prolapse repair, a prophylactic retropubic midurethral sling cuts postoperative urinary incontinence nearly in half — but at the cost of more bladder perforations, UTIs, and voiding dysfunction. This is a shared decision-making conversation: the benefit (NNT 6.3) must be weighed against the patient's individual risk tolerance.