Back to resultsTOMUS-Trial Of Mid-Urethral Slings (TOMUS)
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc)
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Stress, Surgery
Eligibility Criteria
Inclusion Criteria: Female Stress urinary incontinence (SUI) as evidenced by all of the following: Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score) Observation of leakage by provocative stress test at a bladder volume ≤ 300ml Bladder capacity ≥ 200ml by stress test Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed Eligible for both retropubic and transobturator procedures No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer American Society of Anesthesiologists (ASA) class I, II, or III No current intermittent catheterization Available for 24-months of follow-up and able to complete study assessments, per clinician judgment Signed consent form Exclusion Criteria: Age <21 years Non-ambulatory (ambulatory with assistive devices does not exclude the patient) Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant Current chemotherapy or current or history of pelvic radiation therapy Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma) Urethral diverticulum, current or previous (i.e. repaired) Prior augmentation cystoplasty or artificial sphincter Implanted nerve stimulators for urinary symptoms History of synthetic sling for stress urinary incontinence <12 months post-partum Laparoscopic or open pelvic surgery <3 months* Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome) Participation in another treatment intervention trial that might influence the results of this trial Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI
Sites / Locations
- University of Alabama
- University of California
- Kaiser Permanente
- Loyola University Medical Center
- University of Maryland
- Oakwood Hospital/Cancer Center
- William Beaumont Hospital
- University of Pittsburgh
- University of Texas Southwestern
- University of Texas Health Sciences Center
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
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").
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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".
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).
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00325039
Brief Title
TOMUS-Trial Of Mid-Urethral Slings
Acronym
TOMUS
Official Title
TOMUS-Trial Of Mid-Urethral Slings
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Stress, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
597 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
Arm Title
2
Arm Type
Active Comparator
Arm Description
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").
Intervention Type
Procedure
Intervention Name(s)
retropubic mid-urethral sling (TVT)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
transobturator mid-urethral sling (TVT-O and the Monarc)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Treatment Success at 12 Months
Description
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
Title
Subjective Treatment Success at 12 Months
Description
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
Secondary Outcome Measure Information:
Title
Patient Satisfaction at 12 Months
Description
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
Title
Change in Quality of Life From Baseline to 12 Months
Description
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
Title
Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Stress urinary incontinence (SUI) as evidenced by all of the following:
Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months
Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
Observation of leakage by provocative stress test at a bladder volume ≤ 300ml
Bladder capacity ≥ 200ml by stress test
Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower. If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed
Eligible for both retropubic and transobturator procedures
No medical contraindications, e.g., current urinary tract infection (UTI), history of pelvic irradiation, history of lower urinary tract cancer
American Society of Anesthesiologists (ASA) class I, II, or III
No current intermittent catheterization
Available for 24-months of follow-up and able to complete study assessments, per clinician judgment
Signed consent form
Exclusion Criteria:
Age <21 years
Non-ambulatory (ambulatory with assistive devices does not exclude the patient)
Pregnancy by self-report or positive pregnancy test, or self-reported intention to ever become pregnant
Current chemotherapy or current or history of pelvic radiation therapy
Systemic disease known to affect bladder function (i.e., Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma)
Urethral diverticulum, current or previous (i.e. repaired)
Prior augmentation cystoplasty or artificial sphincter
Implanted nerve stimulators for urinary symptoms
History of synthetic sling for stress urinary incontinence
<12 months post-partum
Laparoscopic or open pelvic surgery <3 months*
Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)
Participation in another treatment intervention trial that might influence the results of this trial
Need for concomitant surgery requiring an abdominal incision, use of graft material in the anterior compartment, or any use of synthetic graft material
Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or BE-DRI/E-BE-DRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Gormley, M.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oakwood Hospital/Cancer Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48123
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22378483
Citation
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.
Results Reference
background
PubMed Identifier
21560012
Citation
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.
Results Reference
background
PubMed Identifier
21422865
Citation
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.
Results Reference
background
PubMed Identifier
22542356
Citation
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.
Results Reference
background
PubMed Identifier
21925636
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
background
PubMed Identifier
24772006
Citation
Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.
Results Reference
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PubMed Identifier
20093904
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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.
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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.
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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.
Results Reference
derived
Links:
URL
http://www.uitn.net/
Description
Urinary Incontinence Treatment Network Public Website
Learn more about this trial
TOMUS-Trial Of Mid-Urethral Slings
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