TerminatedPhase 2

A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

90 participantsStarted 2004-06

Plain-language summary

The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions. The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.

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: * History of fecal incontinence; * Incontinence episodes over a 14-day period; * Eighteen years of age or older; Exclusion Criteria: * Abnormalities of the external sphincter greater than 10 mm; * Fibrosis of the tissue at the likely injection sites; * Has a condition that could lead to significant postoperative complications * Rectal varices; * Cancer of the rectum or colon, undergoing active treatment; * Crohn's disease or ulcerative colitis; * Chronic diarrhea unmanageable by drugs and/or diet; * Rectal bleeding; * Pregnant or within one year postpartum.

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

The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score

Timeframe: 6 month

Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.

Timeframe: Throughout study

The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score

Timeframe: 12 month

Trial details

NCT IDNCT00762047

SponsorCarbon Medical Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08

View on ClinicalTrials.gov More Fecal Incontinence trials