OPUS: Outcomes Following Vaginal Prolapse Repair and Midurethral Sling
OPUS was a multicenter, single-blind randomized trial of retropubic Gynecare TVT sling versus sham incisions during vaginal prolapse repair in women without stress-incontinence symptoms; adding the sling reduced the composite of urinary incontinence or treatment at 3 months and urinary incontinence at 12 months, with more operative and voiding complications.[1]
- Design and population
- Multicenter, surgeon-stratified, sham-controlled randomized trial. Women without stress-incontinence symptoms, with a symptomatic vaginal bulge and stage 2 or greater anterior prolapse, planning vaginal prolapse repair at seven clinical sites.
- Arms
- Vaginal prolapse repair plus retropubic Gynecare TVT midurethral sling versus vaginal prolapse repair plus superficial sham suprapubic incisions
- Report and follow-up
- 2012 · 12 months after surgery; 327/337 (97.0%) completed follow-up, and 287/337 (85.2%) had evaluable 12-month primary-outcome data
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| 3-month composite event; risk difference in percentage points, sling minus sham | 39/165 (23.6%) vs 85/172 (49.4%) | difference -25.8; CI -36.1–-15.5; P <0.001 | Met |
| 12-month composite event despite any interval treatment; risk difference in percentage points, sling minus sham | 45/165 (27.3%) vs 74/172 (43.0%) | difference -15.7; CI -26–-5.5; P 0.002 | Met |
Harms: Bladder perforation during sling placement: 11/164 (6.7%) vs 0/172 (0%); Urinary tract infection during first year: 49/158 (31.0%) vs 30/164 (18.3%); Major bleeding or vascular complication: 5/164 (3.0%) vs 0/172 (0%)
Design
At seven clinical sites, women had a bothersome vaginal bulge and stage 2 or greater anterior vaginal-wall prolapse. They had no reported stress-incontinence symptoms on the Pelvic Floor Distress Inventory. Prior sling placement, active SUI treatment, prior urethral surgery or pelvic irradiation, and planned pregnancy during the first postoperative year excluded participation. Surgeons could plan colpocleisis, apical suspension or anterior repair; randomization was stratified by surgeon and planned repair. Participants, centralized telephone interviewers and study coordinators were masked to sling assignment.[1]
The 3-month primary endpoint combined a positive cough stress test, bothersome stress, urge or mixed incontinence symptoms, or treatment for incontinence. The separate 12-month primary endpoint assessed incontinence despite any interval treatment. Missing components of these composites counted as failures. After one interim analysis, the prespecified significance threshold was 0.0469 for the 3-month endpoint; the 12-month hypothesis used 0.05. A preoperative prolapse-reduction cough stress test was performed with the prolapse repositioned by vaginal swabs, so the trial included women with and without demonstrable occult stress leakage.[1]
Results
At 3 months, the primary composite occurred in 39/165 women (23.6%) assigned a sling and 85/172 (49.4%) assigned sham incisions: risk difference −25.8 percentage points (95% CI −36.1 to −15.5; P < 0.001). At 12 months, the second primary composite occurred in 45/165 (27.3%) and 74/172 (43.0%): risk difference −15.7 percentage points (95% CI −26.0 to −5.5; P = 0.002). Both met their prespecified thresholds. The published number needed to treat for the 12-month composite was 6.3 (95% CI 3.9–18).[1]
The objective cough stress test was positive at 3 months in 10/158 (6.3%) sling patients and 54/157 (34.4%) sham patients; bothersome incontinence symptoms occurred in 15/160 (9.4%) and 41/165 (24.8%). These were components of the broader primary endpoint, which also counted urgency leakage and subsequent treatment. At 12 months, changes in stress-symptom and Incontinence Severity Index scores favored sling placement; generic health, sexual function and pain scores did not differ significantly between groups.[1]
A secondary analysis used 457 OPUS participants to develop a seven-predictor model for de novo SUI symptoms through 12 months. Its internally validated concordance index was 0.73 (95% CI 0.65–0.80), and external validation in 316 CARE participants yielded 0.62 (95% CI 0.56–0.69). In 32 held-out OPUS participants, its AUC was 0.72, versus 0.62 for predictions by 22 experts and 0.54 for prolapse-reduction stress testing alone (P < 0.001 for both comparisons). This was a prediction analysis, separate from the randomized sling comparison.[2]
Surgery and treatment delivery
The assigned retropubic sling was Gynecare TVT; the sham procedure made two superficial 1-cm suprapubic incisions. Two of 165 women assigned to the sling did not receive it; all 172 sham-arm women received sham incisions. Mean operative time was 11.4 minutes longer and estimated blood loss 24 mL greater in the sling arm. Over the first year, additional incontinence treatment was given to 12/165 sling patients (7.3%), including surgery in 1/165 (0.6%), and to 19/172 sham patients (11.0%), including surgery in 8/172 (4.7%).[1]
Of 337 randomized women, 327 (97.0%) completed one-year follow-up; primary-outcome data were evaluable for 306 (90.8%) at 3 months and 287 (85.2%) at 12 months. The intention-to-treat composite counted missing data as failure, and sensitivity analyses did not change the efficacy conclusions.[1]
Adverse events
Bladder perforation during sling passage occurred in 11/164 (6.7%) sling patients and 0/172 sham patients; each perforation was managed during the operation. Urinary tract infection occurred in 49/158 (31.0%) versus 30/164 (18.3%). Major bleeding or vascular complications occurred in 5/164 (3.0%) versus 0/172. No sling mesh erosion or exposure was observed in the first year among 160 evaluated sling patients.[1]
Incomplete emptying occurred at discharge in 69/162 (42.6%) versus 51/170 (30.0%), at 2 weeks in 9/163 (5.5%) versus 1/169 (0.6%), and at 6 weeks in 6/162 (3.7%) versus 0/170. Four of 165 sling patients (2.4%) underwent urethrolysis for voiding dysfunction during the first year, versus 0/172 sham patients.[1]
Limitations
The incontinence endpoints combined objective stress leakage, bothersome stress or urgency symptoms, and treatment; they were broader than symptomatic SUI alone. Prolapse repairs varied by surgeon and planned procedure, and the trial was not powered to compare those repair subgroups. Although most women completed a one-year visit, the primary endpoint was evaluable in fewer women; the prespecified missing-data rule and sensitivity analyses addressed this loss. The randomized treatment comparison ended at 12 months.[1]
The risk model used symptoms reported at any point through one year and modestly overpredicted SUI at higher predicted risks; its discrimination was lower in the CARE abdominal-sacrocolpopexy validation cohort than in OPUS.[2]
In conversation
- Builds on CARE (2006). CARE tested prophylactic Burch colposuspension during abdominal sacrocolpopexy; OPUS tested a retropubic sling during vaginal prolapse repair.
- Parallel to CARE (2006). Same prophylaxis question in vaginal prolapse repair: midurethral sling versus sham incision in women without stress incontinence symptoms.
- Parallel to OPTIMAL (2014). Same Pelvic Floor Disorders Network; OPUS randomized a sling in women without stress incontinence having vaginal prolapse surgery; all OPTIMAL women had stress incontinence.
CARE studied a prophylactic Burch colposuspension during abdominal sacrocolpopexy in stress-continent women. OPUS tested a retropubic sling during vaginal repair and used a urinary-incontinence composite that included urgency symptoms and treatment.[1]
Guidelines and approvals
- ACOG/AUGS Practice Bulletin 214 (2019). Counsel women with prolapse but no SUI that postoperative stress incontinence is more likely without a concomitant continence operation, while adverse effects increase with an added procedure .[3]
- AUA/SUFU female SUI guideline (amended 2023). For patients who have SUI and undergo concomitant prolapse repair, clinicians may perform a midurethral sling, pubovaginal sling or Burch colposuspension . The supporting discussion cites OPUS in the separate population without preoperative SUI symptoms.[4]
- EAU female LUTS guideline (2026). Perform a prolapse-reduction test in continent women to identify occult SUI and counsel about adding continence surgery ; for women with symptomatic or occult SUI, offer combined surgery only after discussing benefits and risks, including more adverse events .[5]
- NICE NG123 (2019). For women without incontinence undergoing prolapse surgery, recommendation 1.8.3 says not to offer an operation solely to prevent incontinence ; for women without incontinence considering anterior or apical prolapse surgery, recommendation 1.8.4 calls for explaining the risk of postoperative incontinence and possible later treatment .[6]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2012-06-21 | Randomized 12-month report · primary | — | 3-month composite event; risk difference in percentage points, sling minus sham: 39/165 (23.6%) vs 85/172 (49.4%); difference -25.8; CI -36.1–-15.5; P <0.001 Met 12-month composite event despite any interval treatment; risk difference in percentage points, sling minus sham: 45/165 (27.3%) vs 74/172 (43.0%); difference -15.7; CI -26–-5.5; P 0.002 Met Objective stress leakage; risk difference in percentage points, sling minus sham: 10/158 (6.3%) vs 54/157 (34.4%); difference -28.1; CI -37–-19.2; P <0.001 Symptomatic composite component; risk difference in percentage points, sling minus sham: 15/160 (9.4%) vs 41/165 (24.8%); difference -15.5; CI -23.7–-7.3; P <0.001 | Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. *N Engl J Med.* 2012;366(25):2358-2367. doi:10.1056/NEJMoa1111967 DOI |
| 2014 | Postoperative SUI risk model · secondary | — | Bias-corrected concordance index of seven-predictor model: Development dataset 457 OPUS participants; concordance index 0.73 (95% CI 0.65-0.80). External validation in 316 CARE participants: 0.62 (95% CI 0.56-0.69).; — Area under ROC curve in 32 held-out OPUS participants: Model AUC 0.72 versus 0.62 for 22 experts and 0.54 for the preoperative reduction stress test; P<0.001 for both model comparisons.; — | Jelovsek JE, Chagin K, Brubaker L, et al. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. *Obstet Gynecol.* 2014;123(2 Pt 1):279-287. doi:10.1097/AOG.0000000000000094 DOI |
References
1. Wei JT, Nygaard I, Richter HE, et al. "A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair." N Engl J Med. 2012;366(25):2358-2367. doi:10.1056/NEJMoa1111967
2. Jelovsek JE, Chagin K, Brubaker L, et al. "A Model for Predicting the Risk of De Novo Stress Urinary Incontinence in Women Undergoing Pelvic Organ Prolapse Surgery." Obstet Gynecol. 2014;123(2 Pt 1):279-287. doi:10.1097/AOG.0000000000000094
3. American College of Obstetricians and Gynecologists and American Urogynecologic Society. "Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214." Obstet Gynecol. 2019;134(5):e126-e142. doi:10.1097/AOG.0000000000003519
4. Kobashi KC, Vasavada S, Bloschichak A, et al. "Updates to Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2023)." J Urol. 2023;209(6):1091-1098. doi:10.1097/JU.0000000000003435
5. European Association of Urology. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. Limited update March 2026; section 4.7.5.
6. National Institute for Health and Care Excellence. Urinary incontinence and pelvic organ prolapse in women: management. NG123. 2019; recommendations 1.8.3-1.8.4.