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: September 27, 2013
Last verified: September 2013
  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:


Further study details as provided by Renew Medical:

Primary Outcome Measures:
  • Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings. [ Time Frame: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16). ] [ Designated as safety issue: No ]
    This co-primary effectiveness endpoint was calculated as a relative percentage of the baseline Accidental Bowel Leakage (ABL) using the following equation: % reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline period ABL)

  • Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores. [ Time Frame: Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16). ] [ Designated as safety issue: No ]

    The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20.

    This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner).



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 indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.
Detailed Description:

Prospective, open label, single-arm, non-randomized, multi-center study designed to evaluate the efficacy, safety and tolerability of the Renew Insert in moderate-to-severe bowel incontinence patients: Minimum Wexner score of 12 AND at least weekly (score 3 or higher) leakage of solid and or liquid type stool.

  Eligibility

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

Inclusion Criteria:

  • Signed Informed Consent
  • 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.
  • Patient comprehends study meaning & is capable of carrying out study duties
  • Fluent in English

Exclusion Criteria:

  • American Society of Anesthesiologist (ASA) score of 4 or higher
  • Spinal cord injury or other major neurological diagnosis
  • Known immune deficiency state
  • Significant cardiac arrhythmia
  • Pregnant or Breastfeeding
  • 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
  • Significant medical condition which interferes with study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Principal Investigator: Emily Lukacz, MD University of California, San Diego, CA
Principal Investigator: Mark Segall, MD The medical office of Mark Segall MD
Principal Investigator: Eric G Weiss, 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
Results First Received: July 2, 2013
Last Updated: September 27, 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 July 23, 2014