NCT00325039

TOMUS-Trial Of Mid-Urethral Slings

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 597 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-06-01
• Completion: 2013-06-01
• First posted: 2006-05-11
• Last updated: 2014-01-14
• Results posted: 2012-09-27

Locations

11 sites across 1 country: United States