CompletedNot Applicable

Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence

United States207 participantsStarted 2010-04

Plain-language summary

The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. An adult (\>/= 18 years) female.
✓. FI symptoms for a minimum of 6 months.
✓. Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training.
✓. \<50 years old OR if \>/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines).
✓. FI episodes ≥ 4 in 14 day period.

Exclusion criteria

✕. Unable or unwilling to sign Informed Consent Form or comply with study requirements.
✕. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS.
✕. Allergic to polypropylene.
✕. Pregnant or planning a future pregnancy.
✕. Less than 12 months (365 days) postpartum.
✕. Pelvic prolapse \>/=1 cm beyond the hymen (Stage III \& IV)
✕. Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation.
✕. Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation.

What they're measuring

Percentage of Responders

Timeframe: 12 Months

Trial details

NCT IDNCT01090739

SponsorASTORA Women's Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2016-04-19

View on ClinicalTrials.gov More Fecal Incontinence trials