TOMUS-Trial Of Mid-Urethral Slings

Urinary Incontinence Clinical Trial

— TOMUS  

Official title:

TOMUS-Trial Of Mid-Urethral Slings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325039
• Other study ID #: DK58229
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2006
• Last updated: December 12, 2013
• Start date: April 2006
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: June 2013
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Procedure:
• retropubic mid-urethral sling (TVT)
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.
• transobturator mid-urethral sling (TVT-O and the Monarc)
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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Texas Southwestern	Dallas	Texas
United States	Oakwood Hospital/Cancer Center	Dearborn	Michigan
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	Kaiser Permanente	San Diego	California
United States	University of California	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
New England Research Institutes

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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 — View 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. — View 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. — View 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. 20 — View 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. — View 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. — View 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, — View 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):62 — View 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):913-21. doi: 10.1097/AOG.0b013e31820f3892. — View 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.2010.08.0 — View Citation

Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1). pii: AlboVol8No1. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months	No
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.	12 months	No
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".	Follow-Up	No
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).	Baseline - 12 months	No
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)	12 months	No