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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare) |
|
| 2 | Active Comparator | 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"). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retropubic mid-urethral sling (TVT) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Gormley, M.D. | Dartmouth-Hitchcock Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22378483 | Background | Chai TC, Huang L, Kenton K, Richter HE, Baker J, Kraus S, Litman H; Urinary Incontinence Treatment Network (UITN). Association of baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery. Neurourol Urodyn. 2012 Apr;31(4):496-501. doi: 10.1002/nau.21198. Epub 2012 Feb 29. | |
| 21560012 |
| Label | URL |
|---|---|
| Urinary Incontinence Treatment Network Public Website | View source |
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3521 women were screened for eligibility. 1513 did not meet inclusion criteria; 1259 were eligible for inclusion in the study but were excluded (1001 declined to participate, 258 excluded for administrative reasons). 749 women provided written consent; of these 152 were excluded (63 ineligible, 66 withdrew consent, 23 administrative reasons).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retropubic (RMUS) | retropubic mid-urethral sling (TVT) |
| FG001 | Transobturator (TMUS) | transobturator mid-urethral sling (TVT-O and the Monarc) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retropubic (RMUS) | retropubic mid-urethral sling (TVT) |
| BG001 | Transobturator (TMUS) | transobturator mid-urethral sling (TVT-O and the Monarc) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively). | Posted | Number | percentage of participants | 12 months |
|
Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retropubic (RMUS) | retropubic mid-urethral sling (TVT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesh exposure | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesh exposure | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Litman, PhD | New England Research Institutes, Inc. | 617 972 3297 | hlitman@neriscience.com |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| transobturator mid-urethral sling (TVT-O and the Monarc) | Procedure | 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. |
|
| 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). | 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) | 12 months |
| San Diego |
| California |
| 92103 |
| United States |
| Kaiser Permanente | San Diego | California | 92110 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Oakwood Hospital/Cancer Center | Dearborn | Michigan | 48123 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48123 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Texas Health Sciences Center | San Antonio | Texas | 78229-3900 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Background |
| Nygaard I, Brubaker L, Chai TC, Markland AD, Menefee SA, Sirls L, Sutkin G, Zimmern P, Arisco A, Huang L, Tennstedt S, Stoddard A. Risk factors for urinary tract infection following incontinence surgery. Int Urogynecol J. 2011 Oct;22(10):1255-65. doi: 10.1007/s00192-011-1429-9. Epub 2011 May 11. |
| 21422865 | Background | Richter HE, Litman HJ, Lukacz ES, Sirls LT, Rickey L, Norton P, Lemack GE, Kraus S, Moalli P, Fitzgerald MP, Dandreo KJ, Huang L, Kusek JW; Urinary Incontinence Treatment Network. Demographic and clinical predictors of treatment failure one year after midurethral sling surgery. Obstet Gynecol. 2011 Apr;117(4):913-921. doi: 10.1097/AOG.0b013e31820f3892. |
| 22542356 | Background | Chai TC, Kenton K, Xu Y, Sirls L, Zyczynski H, Wilson TS, Rahn DD, Whitcomb EL, Hsu Y, Gormley EA. Effects of concomitant surgeries during midurethral slings (MUS) on postoperative complications, voiding dysfunction, continence outcomes, and urodynamic variables. Urology. 2012 Jun;79(6):1256-61. doi: 10.1016/j.urology.2012.02.048. Epub 2012 Apr 25. |
| 21925636 | Background | Brubaker L, Norton PA, Albo ME, Chai TC, Dandreo KJ, Lloyd KL, Lowder JL, Sirls LT, Lemack GE, Arisco AM, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. 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 Nov;205(5):498.e1-6. doi: 10.1016/j.ajog.2011.07.011. Epub 2011 Jul 20. |
| 21683412 | Background | Nager CW, Sirls L, Litman HJ, Richter H, Nygaard I, Chai T, Kraus S, Zyczynski H, Kenton K, Huang L, Kusek J, Lemack G; Urinary Incontinence Treatment Network. Baseline urodynamic predictors of treatment failure 1 year after mid urethral sling surgery. J Urol. 2011 Aug;186(2):597-603. doi: 10.1016/j.juro.2011.03.105. Epub 2011 Jun 16. |
| 24772006 | Result | Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1. |
| 20093904 | Result | Brubaker L, Rickey L, Xu Y, Markland A, Lemack G, Ghetti C, Kahn MA, Nagaraju P, Norton P, Chang TD, Stoddard A; Urinary Incontinence Treatment Network. Symptoms of combined prolapse and urinary incontinence in large surgical cohorts. Obstet Gynecol. 2010 Feb;115(2 Pt 1):310-316. doi: 10.1097/AOG.0b013e3181cb86b2. |
| 20127832 | Result | Nager CW, Kraus SR, Kenton K, Sirls L, Chai TC, Wai C, Sutkin G, Leng W, Litman H, Huang L, Tennstedt S, Richter HE; Urinary Incontinence Treatment Network. Urodynamics, the supine empty bladder stress test, and incontinence severity. Neurourol Urodyn. 2010 Sep;29(7):1306-11. doi: 10.1002/nau.20836. |
| 20479459 | Result | Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. doi: 10.1056/NEJMoa0912658. Epub 2010 May 17. |
| 20018326 | Result | Richter HE, Kenton K, Huang L, Nygaard I, Kraus S, Whitcomb E, Chai TC, Lemack G, Sirls L, Dandreo KJ, Stoddard A. The impact of obesity on urinary incontinence symptoms, severity, urodynamic characteristics and quality of life. J Urol. 2010 Feb;183(2):622-8. doi: 10.1016/j.juro.2009.09.083. Epub 2009 Dec 16. |
| 20952014 | Result | Sirls LT, Tennstedt S, Albo M, Chai T, Kenton K, Huang L, Stoddard AM, Arisco A, Gormley EA. Factors associated with quality of life in women undergoing surgery for stress urinary incontinence. J Urol. 2010 Dec;184(6):2411-5. doi: 10.1016/j.juro.2010.08.019. Epub 2010 Oct 16. |
| 25800900 | Derived | Brubaker L, Litman HJ, Kim HY, Zimmern P, Dyer K, Kusek JW, Richter HE, Stoddard A; Urinary Incontinence Treatment Network. Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women. Int Urogynecol J. 2015 Aug;26(8):1155-9. doi: 10.1007/s00192-015-2661-5. Epub 2015 Mar 24. |
| 23635737 | Derived | Wai CY, Curto TM, Zyczynski HM, Stoddard AM, Burgio KL, Brubaker L, Rickey LM, Menefee SA; Urinary Incontinence Treatment Network*. Patient satisfaction after midurethral sling surgery for stress urinary incontinence. Obstet Gynecol. 2013 May;121(5):1009-1016. doi: 10.1097/AOG.0b013e31828ca49e. |
| BG002 | Total | Total of all reporting groups |
| Yrs |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
retropubic mid-urethral sling (TVT)
| OG001 | Transobturator (TMUS) | transobturator mid-urethral sling (TVT-O and the Monarc) |
|
|
|
| Secondary | 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". | This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm) | Posted | Number | percentage of participants analyzed | Follow-Up |
|
|
|
|
| Primary | 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. | Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm). | Posted | Number | percentage of participants | 12 months |
|
|
|
|
| Secondary | 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). | These are the number of patients with available quality of life data at the 12 month visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 months |
|
|
|
|
| Secondary | 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) | This is the number of participants who had complete UDI information at the 12 month visit. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| 41 |
| 298 |
| 110 |
| 298 |
| EG001 | Transobturator (TMUS) | transobturator mid-urethral sling (TVT-O and the Monarc) | 19 | 299 | 89 | 299 |
| Mesh erosion | Surgical and medical procedures | Non-systematic Assessment |
|
| Surgical site infection | Surgical and medical procedures | Non-systematic Assessment |
|
| Granulation tissue | Surgical and medical procedures | Non-systematic Assessment |
|
| Urethral perforation | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder perforation | Surgical and medical procedures | Non-systematic Assessment |
|
| Vaginal epithelial perforation | Surgical and medical procedures | Non-systematic Assessment |
|
| Recurrent cystitis, leading to diagnostic cystoscopy | Renal and urinary disorders | Non-systematic Assessment |
|
| Pulmonary embolus | Vascular disorders | Non-systematic Assessment |
|
| Postoperative bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neurologic symptoms | Nervous system disorders | Non-systematic Assessment |
|
| Voiding dysfunction requiring surgery, use of catheter or both | Renal and urinary disorders | Non-systematic Assessment |
|
| Urothelial abrasion | Surgical and medical procedures | Non-systematic Assessment |
|
| Surgical site infection | Surgical and medical procedures | Non-systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Non-systematic Assessment |
|
| Vascular or hematologic | Vascular disorders | Non-systematic Assessment |
|
| Neurologic symptom of numbness | Nervous system disorders | Non-systematic Assessment |
|
| Neurologic symptom of weakness | Nervous system disorders | Non-systematic Assessment |
|
| Voiding dysfunction | Renal and urinary disorders | Non-systematic Assessment |
|
| Self-reported pain 6 or more weeks after procedure | General disorders | Non-systematic Assessment |
|
| New urge incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Persistent urge incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Granulation tissue | Surgical and medical procedures | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Thrush | General disorders | Non-systematic Assessment |
|
| Wound edge separation | Surgical and medical procedures | Non-systematic Assessment |
|
| Minor wound | Surgical and medical procedures | Non-systematic Assessment |
|
| Medication reaction | General disorders | Non-systematic Assessment |
|
| Skin irritation | General disorders | Non-systematic Assessment |
|
| Sac in pelvis (seroma) | Renal and urinary disorders | Non-systematic Assessment |
|
| Bilateral leg pain | General disorders | Non-systematic Assessment |
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| Decreased bladder sensation | General disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.