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A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage (REST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renew Medical
ClinicalTrials.gov Identifier:
NCT01475474
First received: November 10, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Bowel Incontinence
 Device: Renew Insert

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Non-Randomized Study of the Renew Insert Efficacy, Safety and Tolerability For the Management of Accidental Bowel Leakage Due to Bowel Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Renew Medical:

Primary Outcome Measures:
  • Co-primary efficacy endpoint: A reduction in episodes of accidental bowel leakage through the treatment period as measured objectively by diary recordings. [ Time Frame: Daily diary of accidental bowel leakage from Baseline (Weeks 1-4) through Treatment phase (Weeks 5-16) and Return to Baseline phase (Weeks 17-20). ] [ Designated as safety issue: No ]
  • Co-primary efficacy endpoint: A reduction in Wexner score (or bowel incontinence) severity. [ Time Frame: Wexner score will be calculated in the Baseline phase (Weeks 1-4) and Return to Baseline phase (Weeks 17-20). ] [ Designated as safety issue: No ]
  • The primary safety endpoint is absence of any device related serious adverse events. [ Time Frame: Serious Adverse Events will be assessed from the signing of the informed consent document through the end of Return to Baseline Phase (Week 20). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absence of serious irritation of the anal canal or lower rectal mucosa. [ Time Frame: Digital rectal exams and anoscopies will be performed in Enrollment phase (Week 0) and Week 12 of Treatment phase. ] [ Designated as safety issue: Yes ]

Enrollment: 97
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Renew Insert
    The Renew Insert is a single use anal insert designed to seal and prevent the involuntary passage of stool from the rectum.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Spinal cord injury or other major neurological diagnosis
  • Known immune deficiency state
  • Significant cardiac arrhythmia
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475474

Locations
United States, California
Dr. Segall
Los Gatos, California, United States, 95032
UCSD Medical Center
San Diego, California, United States, 92103-8897
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Renew Medical
Investigators
Principal Investigator: Steven D Wexner, MD Cleveland Clinic Florida
  More Information

No publications provided

Responsible Party: Renew Medical
ClinicalTrials.gov Identifier: NCT01475474     History of Changes
Other Study ID Numbers: Renew Medical - 210CLD
Study First Received: November 10, 2011
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Renew Medical:
incontinence
bowel
movement
fecal
anal
diarrhea
stool
rectal
feces
 uncontrolled
loose
leakage
rectum
BM
watery
urgent
flatulence
gas

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013