TOMUS: Trial of Mid-Urethral Slings

Bottom line Mixed

Retropubic TVT and transobturator TVT-O or Monarc had equivalent objective success at 12 months (80.8% versus 77.7%) under TOMUS's ±12-point margin; subjective success (62.2% versus 55.8%) did not meet equivalence. Complication patterns differed by route.

Objective 12-month equivalence met; subjective equivalence did not.

TOMUS was a multicenter, open-label randomized equivalence trial comparing retropubic tension-free vaginal tape (TVT) with transobturator TVT-O or Monarc in women with stress-predominant urinary incontinence; its 12-month objective success composite met the prespecified equivalence margin, while its subjective composite did not.^[1]

Design and population

Multicenter randomized equivalence trial. Women aged at least 21 years with at least 3 months of stress-predominant incontinence and a positive stress test at bladder volume 300 mL or less; 597 randomized at 9 US sites.

Arms

Retropubic tension-free vaginal tape (TVT) versus transobturator TVT-O (inside-out) or Monarc (outside-in)

Report and follow-up

2010 · 12 months; 565/597 assessed or counted as failures

Endpoint	Results	Effect	Finding
12-month objective composite; retropubic minus transobturator risk difference, percentage points	80.8% vs 77.7%	difference 3; CI -3.6–9.6	Met
12-month subjective composite; retropubic minus transobturator risk difference, percentage points	62.2% vs 55.8%	difference 6.4; CI -1.6–14.3	Not met

Harms: Intraoperative bladder perforation: 15/298 (5.0%) vs 0/299 (0%); Voiding dysfunction requiring surgery by 12 months: 8/298 (2.7%) vs 0/299 (0%); Neurologic symptoms assessed through 6 weeks: 12/298 (4.0%) vs 28/299 (9.4%)

NCT00325039 · Report DOI

Design

Women aged at least 21 years had stress-predominant symptoms for at least 3 months and a positive stress test at a bladder volume of 300 mL or less. Urodynamic stress leakage was not required. The trial randomized 597 women at 9 US sites after anesthesia was administered. Its 43 certified surgeons used standardized sling elements and cystoscopy; the surgeon was masked to preoperative urodynamic results, while the patient knew the assigned operation afterward. Concomitant vaginal surgery was permitted.^[1]

The two 12-month primary composites asked different questions. Objective success required a negative provocative stress test, negative 24-hour pad test, and no behavioral, drug, or surgical retreatment for stress incontinence. Subjective success required no stress symptoms on the MESA questionnaire, no leakage in a 3-day diary, and no retreatment. Equivalence required the entire 95% confidence interval for the retropubic-minus-transobturator risk difference to fall within ±12 percentage points.^[1]

Results

Of 597 randomized women, 565 were assessed or counted as failures by 12 months. Objective success was 80.8% after retropubic TVT and 77.7% after transobturator sling, a 3.0-point risk difference (95% CI −3.6 to 9.6) that met equivalence. Subjective success was 62.2% and 55.8%, a 6.4-point difference (95% CI −1.6 to 14.3); its upper bound exceeded the +12-point margin. Both are composites, and their reported rates are estimates rather than simple fractions of the randomized arms.^[1]

At 24 months, 516 of 597 women were assessed or counted as failures. Objective success was 77.3% versus 72.3% (retropubic-minus-transobturator difference 5.1 points, 95% CI −2.0 to 12.1), and subjective success was 55.7% versus 48.3% (difference 7.4 points, 95% CI −0.7 to 15.5). Neither interval fell wholly within the original ±12-point equivalence margin.^[2]

The five-year observational extension enrolled 404 of the original 597 women (68%); its time-to-failure analysis included 583 per-protocol operated women. It used a different endpoint: no retreatment and no self-reported stress symptoms. Estimated success was 51.3% after retropubic versus 43.4% after transobturator sling (difference 7.9 points, 95% CI −1.4 to 17.2). This missed the extension's ±15-point equivalence margin; the interval also crossed zero. Satisfaction was 79% and 85%, respectively.^[3]

Surgery and treatment delivery

Retropubic surgery used Gynecare TVT passed behind the pubis. Transobturator surgeons chose either inside-out Gynecare TVT-O or outside-in AMS Monarc through the obturator foramen and declared that choice before enrollment. Among transobturator recipients, 161 received inside-out and 137 outside-in placement; one woman assigned transobturator surgery received a retropubic sling. Those transobturator methods were not randomized against one another.^[1]

The median sling-portion operative time was 30 versus 25 minutes, and median estimated blood loss was 50 versus 25 mL, retropubic versus transobturator. In the per-protocol population, 291 retropubic and 292 transobturator assignments received the specified operation.^[1]

Adverse events

At the primary report's 12-month assessment, bladder perforation during trocar passage occurred in 15/298 (5.0%) retropubic assignments and 0/299 transobturator assignments; detected perforations were managed by trocar replacement. Voiding dysfunction requiring surgery occurred in 8/298 (2.7%) and 0/299. Neurologic symptoms assessed through the 6-week visit, including leg weakness or groin numbness, occurred in 12/298 (4.0%) and 28/299 (9.4%).^[1]

The dedicated 24-month adverse-event report counted at least one serious event in 46/298 (15.4%) retropubic and 26/299 (8.7%) transobturator assignments. Its modified Dindo system classified intraoperative perforation requiring trocar replacement as serious. Voiding dysfunction requiring surgery, catheter use, or both reached 9/298 (3.0%) versus 0/299; vaginal mesh exposure affected 13/298 (4.4%) versus 8/299 (2.7%), and neurologic adverse events 16/298 (5.4%) versus 29/299 (9.7%). Four neurologic symptoms remained unresolved at 24 months across both groups. The retropubic group also had more postoperative urinary tract infections.^[4]

The five-year extension identified seven new mesh complications, three after retropubic and four after transobturator placement.^[3]

Limitations

Patients and surgeons were not masked to the operation after surgery, which matters particularly for the symptom and satisfaction endpoints. The two transobturator devices and passage directions were selected by surgeons, so their post hoc comparison was not randomized. The five-year extension enrolled 68% of the original randomized women, excluded women surgically retreated before invitation, and changed the success definition; its longer-term estimates are sensitive to loss to follow-up.^[1][3]

In conversation

Same setting SIMS (2022)

Guidelines and approvals

AUA/SUFU, 2023. For index patients who select midurethral sling surgery, clinicians may offer a retropubic, transobturator, or single-incision sling .^[5]

Report history

TOMUS report history

Published	Report	Cutoff	Headline results	Citation
2010-05-17	12-month primary report · primary	—	12-month objective composite; retropubic minus transobturator risk difference, percentage points: 80.8% vs 77.7%; difference 3; CI -3.6–9.6 Met 12-month subjective composite; retropubic minus transobturator risk difference, percentage points: 62.2% vs 55.8%; difference 6.4; CI -1.6–14.3 Not met	Richter HE, Albo ME, Zyczynski HM, et al. "Retropubic versus Transobturator Midurethral Slings for Stress Incontinence." *N Engl J Med.* 2010;362(22):2066-2076. doi:10.1056/NEJMoa0912658 DOI
2011	Two-year adverse events · secondary	—	—	Brubaker L, Norton PA, Albo ME, et al. "Adverse Events over Two Years after Retropubic or Transobturator Midurethral Sling Surgery: Findings from the Trial of Midurethral Slings (TOMUS) Study." *Am J Obstet Gynecol.* 2011;205(5):498.e1-498.e6. doi:10.1016/j.ajog.2011.07.011 DOI
2012-10-22	24-month efficacy · updated	—	24-month objective composite; retropubic minus transobturator risk difference, percentage points: 77.3% vs 72.3%; difference 5.1; CI -2–12.1 Not met 24-month subjective composite; retropubic minus transobturator risk difference, percentage points: 55.7% vs 48.3%; difference 7.4; CI -0.7–15.5 Not met	Albo ME, Litman HJ, Richter HE, et al. "Treatment Success of Retropubic and Transobturator Mid Urethral Slings at 24 Months." *J Urol.* 2012;188(6):2281-2287. doi:10.1016/j.juro.2012.07.103 DOI
2014-08-23	Five-year observational follow-up · secondary	—	Five-year cohort success without SUI symptoms or retreatment; retropubic minus transobturator risk difference, percentage points: 51.3% vs 43.4%; difference 7.9; CI -1.4–17.2 Not met Five-year patient satisfaction: 79% vs 85%; P 0.15	Kenton K, Stoddard AM, Zyczynski H, et al. "5-Year Longitudinal Followup after Retropubic and Transobturator Mid Urethral Slings." *J Urol.* 2015;193(1):203-210. doi:10.1016/j.juro.2014.08.089 DOI

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References

1. Richter HE, Albo ME, Zyczynski HM, et al. "Retropubic versus Transobturator Midurethral Slings for Stress Incontinence." N Engl J Med. 2010;362(22):2066-2076. doi:10.1056/NEJMoa0912658

2. Albo ME, Litman HJ, Richter HE, et al. "Treatment Success of Retropubic and Transobturator Mid Urethral Slings at 24 Months." J Urol. 2012;188(6):2281-2287. doi:10.1016/j.juro.2012.07.103

3. Kenton K, Stoddard AM, Zyczynski H, et al. "5-Year Longitudinal Followup after Retropubic and Transobturator Mid Urethral Slings." J Urol. 2015;193(1):203-210. doi:10.1016/j.juro.2014.08.089

4. Brubaker L, Norton PA, Albo ME, et al. "Adverse Events over Two Years after Retropubic or Transobturator Midurethral Sling Surgery: Findings from the Trial of Midurethral Slings (TOMUS) Study." Am J Obstet Gynecol. 2011;205(5):498.e1-498.e6. doi:10.1016/j.ajog.2011.07.011

5. American Urological Association and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. Amendment 2023. Statement 13.