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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Durasphere

Group Type EXPERIMENTAL

Durasphere FI

Intervention Type DEVICE

Durasphere Injection

Sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Sham injection with anesthesia

Interventions

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Durasphere FI

Durasphere Injection

Intervention Type DEVICE

Sham

Sham injection with anesthesia

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes