A Phase 4 interventional study of retropubic mid-urethral sling (TVT) and transobturator mid-urethral sling (TVT-O and the Monarc) in Urinary Incontinence, sponsored by Carelon Research. Completed at 11 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-14.
Sponsored by Carelon Research · Phase 4, Interventional, and Treatment
The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 597 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
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Exclusion Criteria:
retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
Procedure: retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc) Two transobturator slings were used: the Tension-free Vaginal Tape Obturator (Gynecare), which is placed starting inside the vagina and coming out through the obturator foramen ("in-to-out") or the Monarc (American Medical System), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina ("out-to-in").
Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)
This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.
This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.
Objective Treatment Success at 12 Months
Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is \<15g/24 hrs.
Time frame: 12 months
Subjective Treatment Success at 12 Months
Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.
Time frame: 12 months
Patient Satisfaction at 12 Months
Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".
Time frame: Follow-Up
Change in Quality of Life From Baseline to 12 Months
Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).
Time frame: Baseline - 12 months
Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)
Time frame: 12 months
Recruitment took place between April 2006 and June 2008. Patients were recruited from nine clinical sites. TOMUS (Trial Of Mid-Urethral Slings) was conducted by the Urinary Incontinence Treatment Network (UITN), a cooperative network consisting of urologists and urogynecologists at 9 clinical centers and a biostatistical coordinating center.
| Milestone | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Started | 298 | 299 |
| Completed | 280 | 285 |
| Not completed | 18 | 14 |
| Withdrew: Lost to follow-up | 18 | 14 |
Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is \<15g/24 hrs.
| percentage of participants | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Objective Treatment Success at 12 Months | 80.8 | 77.7 |
Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".
| percentage of participants analyzed | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Patient Satisfaction at 12 Months | 85.9 | 90.0 |
Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.
| percentage of participants | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Subjective Treatment Success at 12 Months | 62.2 | 55.8 |
Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).
| units on a scale | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Change in Quality of Life From Baseline to 12 Months | 126.8 ± 94.5 | 132.9 ± 97.8 |
Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)
| units on a scale | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months | 106.7 ± 48.0 | 110.3 ± 51.2 |
Collected over Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Retropubic (RMUS) | — | 41/298 (13.8%) | 110/298 (36.9%) |
| Transobturator (TMUS) | — | 19/299 (6.4%) | 89/299 (29.8%) |
| Event | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| Bladder perforationSurgical and medical procedures | 15/298 | 0/299 |
| Vaginal epithelial perforationSurgical and medical procedures | 6/298 | 13/299 |
| Mesh exposureSurgical and medical procedures | 9/298 | 5/299 |
| Voiding dysfunction requiring surgery, use of catheter or bothRenal and urinary disorders | 8/298 | 0/299 |
| Surgical site infectionSurgical and medical procedures | 0/298 | 2/299 |
| Mesh erosionSurgical and medical procedures | 1/298 | 1/299 |
| Urethral perforationRenal and urinary disorders | 1/298 | 0/299 |
| Recurrent cystitis, leading to diagnostic cystoscopyRenal and urinary disorders | 1/298 | 0/299 |
| Postoperative bleedingBlood and lymphatic system disorders | 1/298 | 0/299 |
| Neurologic symptomsNervous system disorders | 1/298 | 0/299 |
| Event | Retropubic (RMUS) | Transobturator (TMUS) |
|---|---|---|
| GenitourinaryRenal and urinary disorders | 40/298 | 24/299 |
| Persistent urge incontinenceRenal and urinary disorders | 36/298 | 30/299 |
| Neurologic symptom of weaknessNervous system disorders | 7/298 | 21/299 |
| Vascular or hematologicVascular disorders | 18/298 | 7/299 |
| Voiding dysfunctionRenal and urinary disorders | 10/298 | 4/299 |
| Self-reported pain 6 or more weeks after procedureGeneral disorders | 7/298 | 6/299 |
| Neurologic symptom of numbnessNervous system disorders | 6/298 | 7/299 |
| Mesh exposureSurgical and medical procedures | 4/298 | 3/299 |
| Surgical site infectionSurgical and medical procedures | 2/298 | 2/299 |
| Granulation tissueSurgical and medical procedures | 2/298 | 2/299 |
| Age, Continuous(Yrs) | Retropubic (RMUS) | Transobturator (TMUS) | Total |
|---|---|---|---|
| Mean | 52.7 ± 10.5 | 53.1 ± 11.5 | 52.9 ± 11.0 |
| Sex: Female, Male(Participants) | Retropubic (RMUS) | Transobturator (TMUS) | Total |
|---|---|---|---|
| Female | 298 | 299 | 597 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Retropubic (RMUS) | Transobturator (TMUS) | Total |
|---|---|---|---|
| United States | 298 | 299 | 597 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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