TOMUS-Trial Of Mid-Urethral Slings

PHASE4CompletedINTERVENTIONAL
Enrollment

597

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2013

Conditions
Urinary Incontinence
Interventions
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.

Trial Locations (11)

15213

University of Pittsburgh, Pittsburgh

21201

University of Maryland, Baltimore

35294

University of Alabama, Birmingham

48123

Oakwood Hospital/Cancer Center, Dearborn

William Beaumont Hospital, Royal Oak

60153

Loyola University Medical Center, Maywood

75390

University of Texas Southwestern, Dallas

84132

University of Utah, Salt Lake City

92103

University of California, San Diego

92110

Kaiser Permanente, San Diego

78229-3900

University of Texas Health Sciences Center, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Carelon Research

OTHER

NCT00325039 - TOMUS-Trial Of Mid-Urethral Slings | Biotech Hunter | Biotech Hunter