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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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