Back to resultsA Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage (REST)
Primary Purpose
Bowel Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renew Insert
Sponsored by
About this trial
This is an interventional treatment trial for Bowel Incontinence focused on measuring incontinence, bowel, movement, fecal, anal, diarrhea, stool, rectal, feces, uncontrolled, loose, leakage, rectum, BM, watery, urgent, flatulence, gas
Eligibility 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
Sites / Locations
- Dr. Segall
- UCSD Medical Center
- Cleveland Clinic Florida
Outcomes
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.
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01475474
Brief Title
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
Acronym
REST
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renew Medical
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Incontinence
Keywords
incontinence, bowel, movement, fecal, anal, diarrhea, stool, rectal, feces, uncontrolled, loose, leakage, rectum, BM, watery, urgent, flatulence, gas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Renew Insert
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).
Title
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.
Description
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).
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Wexner, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily Lukacz, MD
Organizational Affiliation
University of California, San Diego, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Segall, MD
Organizational Affiliation
The medical office of Mark Segall MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric G Weiss, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Segall
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8897
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26252852
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
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