Transform

Clinical Study to Investigate the Effectiveness of the TOPAS Sling System to Treat Fecal Incontinence (TRANSFORM)

Transform [NCT01090739]

Description: Clinical Study to Investigate the Effectiveness of the TOPAS Sling System to Treat Fecal Incontinence (TRANSFORM)

Device: TOPAS sling system

 

Primary Investigator: Karram

Drug/Device Information
Women with fecal Incontinence
TOPAS sling system
Non-randomized
American Medical Systems
Major Inclusion and Exclusion
Women with fecal incontinence for a minimum of 6 months
Must have failed two conservative therapies such as; diet, medication, or muscle training
Must have had ≥ 4 episodes of fecal incontinence in a 14 day period
No inflammatory bowel disease such as; ulcerative colitis or Crohn's disease