CompletedNot Applicable

A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage

United States97 participantsStarted 2009-12

Plain-language summary

The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed Informed Consent * Minimum Wexner Bowel incontinence score of 12 AND at least weekly (score of 3 or higher) leakage of solid and/or liquid type stool, with no greater than 50% of subjects with daily (score 4) of uncontrolled gas. * Patients colon surveillance must be in compliance with American Cancer Society colon screening guidelines. If patient is out of compliance, they may be scheduled for Colonoscopy. * Patient comprehends study meaning \& is capable of carrying out study duties * Fluent in English Exclusion Criteria: * American Society of Anesthesiologist (ASA) score of 4 or higher * Spinal cord injury or other major neurological diagnosis * Known immune deficiency state * Significant cardiac arrhythmia * Pregnant or Breastfeeding * Inflammatory bowel disease * Requirement of medication delivered by suppository * Active perianal abscess or fistula * Present rectal prolapse * Third degree hemorrhoids * Anal stricture * History or rectal spasm * Rectal surgery in past 6 months * Unresolved Anismus * Fecal impaction with overflow diarrhea * Ileo-anal pouch * Rectocele requiring surgery * Allergy to silicone or one of its components * Significant medical condition which interferes with study participation

What they're measuring

Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.

Timeframe: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).

Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores.

Timeframe: Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16).

Trial details

NCT IDNCT01475474

SponsorRenew Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

Results submitted2013-07-02

View on ClinicalTrials.gov More Bowel Incontinence trials