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

• ClinicalTrials.gov Identifier: NCT01475474
• Recruitment Status: Completed
• First Posted: November 21, 2011
• Results First Posted: November 28, 2013
• Last Update Posted: November 28, 2013
• Sponsor: Renew Medical
• Information provided by (Responsible Party): Renew Medical

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Bowel Incontinence	Device: Renew Insert	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: December 2009
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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). ]
   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)
2. 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). ]

   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lukacz ES, Segall MM, Wexner SD. Evaluation of an Anal Insert Device for the Conservative Management of Fecal Incontinence. Dis Colon Rectum. 2015 Sep;58(9):892-8. doi: 10.1097/DCR.0000000000000427.

• Responsible Party: Renew Medical
• ClinicalTrials.gov Identifier: NCT01475474
• Other Study ID Numbers: Renew Medical - 210CLD
• First Posted: November 21, 2011
• Results First Posted: November 28, 2013
• Last Update Posted: November 28, 2013
• Last Verified: September 2013

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