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

Completed · Not applicable

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID: NCT01090739
Run by: ASTORA Women's Health
People needed: 207
Starts: 2010-04-01
Expected to finish: 2016-04-01
Last updated by the study team: 2016-08-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Subject is/has:
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.

You may not qualify if…

Subject is/has
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.
Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation.
Planning pelvic surgery within 12 months (365 days) post implant
Current Grade III or IV hemorrhoids.
Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor.
Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease).
Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence.
Severe chronic constipation, including obstructive defecatory disorder.
External full thickness rectal prolapse.
A history of laxative abuse within the past 5 years.
Had previous rectal resection.
Active pelvic infection, perianal or recto-vaginal fistula.
Congenital anorectal malformations or chronic 4th degree lacerations and cloacae.
History of therapeutic radiation for cancers of the pelvis.
Currently implanted with a sacral nerve stimulator.
Contraindicated for surgery or having any condition that would compromise wound healing.

Where it is running

University of California SF - Mt Zion Medical Center — San Francisco, California, United States
University of South Florida — Tampa, Florida, United States
Cleveland Clinic Foundation - Florida — Weston, Florida, United States
Raybon OB-GYN — Toccoa, Georgia, United States
University of Michigan — Ann Arbor, Michigan, United States
Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
Atlantic Health System — Morristown, New Jersey, United States
University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
The Christ Hospital — Cincinnati, Ohio, United States
Cleveland Clinic Foundation - Ohio — Cleveland, Ohio, United States
University of Oklahoma — Oklahoma City, Oklahoma, United States
St. Luke's Hospital — Allentown, Pennsylvania, United States
Womens Hospital of Texas — Houston, Texas, United States
Sacred Heart Medical Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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