NCT00762047

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 30, 2013

Status Verified

January 1, 2012

Enrollment Period

4.2 years

First QC Date

September 29, 2008

Last Update Submit

July 29, 2013

Conditions

Fecal Incontinence

Keywords

Fecal Incontinence

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Durasphere

EXPERIMENTAL
Device: Durasphere FI

Sham

SHAM COMPARATOR
Device: Sham

Interventions

Durasphere FIDEVICE

Durasphere Injection

Durasphere
ShamDEVICE

Sham injection with anesthesia

Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of fecal incontinence;
  • Incontinence episodes over a 14-day period;
  • Eighteen years of age or older;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

June 1, 2004

Primary Completion

August 1, 2008

Study Completion

June 1, 2009

Last Updated

July 30, 2013

Record last verified: 2012-01