Clinical trial NCT00325039: TOMUS-Trial Of Mid-Urethral Slings
Official title: TOMUS-Trial Of Mid-Urethral Slings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence, Stress
Surgery
Lead sponsor: Carelon Research
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 597
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Objective Treatment Success at 12 Months
timeFrame: 12 months
measure: Subjective Treatment Success at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Patient Satisfaction at 12 Months
timeFrame: Follow-Up
measure: Change in Quality of Life From Baseline to 12 Months
timeFrame: Baseline - 12 months
measure: Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital/Cancer Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ann Gormley, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
citation: Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.