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

Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00762047

Enrollment

Registered

2008-09-30

Start date

2004-06-30

Completion date

2009-06-30

Last updated

2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

Keywords

Fecal Incontinence

Brief 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.

Interventions

DEVICEDurasphere FI

Durasphere Injection

DEVICESham

Sham injection with anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score	6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.	Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score	12 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026