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

• Sponsor: Renew Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01475474
• Collaborator: (none)
• Enrollment: 97
• Locations: 3
• Duration (Months): 24
• Patients Per Site: 32.3
• Patients Per Site Per Month: 1.3

Study Details

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	N/A

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
• 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: Dec 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

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. [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. [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Dr. Segall	Los Gatos	California	United States	95032
2	UCSD Medical Center	San Diego	California	United States	92103-8897
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renew Medical
• ClinicalTrials.gov Identifier: NCT01475474
• Other Study ID Numbers: Renew Medical - 210CLD
• First Posted: Nov 21, 2011
• Last Update Posted: Nov 28, 2013
• Last Verified: Sep 1, 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

Study Results

Participant Flow

Recruitment Details	Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period. The study started in December 2009 and completed in December 2011.
Pre-assignment Detail	Renew Medical conducted a multi-center, prospective, open label, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to severe bowel incontinence (defined as having a Wexner score greater than 12).

Arm/Group Title	Renew Insert for Management of Accidental Bowel Leakage
Arm/Group Description	The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user.
Period Title: Baseline Period - 4 Weeks
STARTED	97
COMPLETED	91
NOT COMPLETED	6
Period Title: Baseline Period - 4 Weeks
STARTED	91
COMPLETED	73
NOT COMPLETED	18
Period Title: Baseline Period - 4 Weeks
STARTED	73
COMPLETED	71
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Renew Insert for Management of Accidental Bowel Leakage
Arm/Group Description
Overall Participants	97
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	34 35.1%
>=65 years	63 64.9%
Sex: Female, Male (Count of Participants)
Female	88 90.7%
Male	9 9.3%
Region of Enrollment (participants) [Number]
United States	97 100%

Outcome Measures

1. Primary Outcome

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).

Outcome Measure Data

Analysis Population Description

Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.

Arm/Group Title	Modified Intent-To-Treat Cohort
Arm/Group Description	Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
Measure Participants	85
Median (Inter-Quartile Range) [percentage change]	-81.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Modified Intent-To-Treat Cohort
	Comments	Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon Signed-Rank Test
	Comments

2. Primary Outcome

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).

Outcome Measure Data

Analysis Population Description

Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.

Arm/Group Title	Modified Intent to Treat Cohort (MITT)
Arm/Group Description	Modified Intent-to-Treat cohort included all subjects who completed at least one week of Insert use during the 12 Week Treatment Period.
Measure Participants	77
Median (Inter-Quartile Range) [Percentage change]	-29.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Modified Intent-To-Treat Cohort
	Comments	Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon Signed-Rank Test
	Comments

Adverse Events

Time Frame	Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Arm/Group Title	Intent-to-treat (ITT) Cohort
Arm/Group Description	Subjects who used the Renew Insert.
All Cause Mortality
	Intent-to-treat (ITT) Cohort
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intent-to-treat (ITT) Cohort
	Affected / at Risk (%)	# Events
Total	0/91 (0%)
Other (Not Including Serious) Adverse Events
	Intent-to-treat (ITT) Cohort
	Affected / at Risk (%)	# Events
Total	91/91 (100%)
Gastrointestinal disorders
Abdominal Pain	5/91 (5.5%)
Accidental Bowel Leakage	5/91 (5.5%)
Anorectal Bleeding	8/91 (8.8%)
Anorectal Irritation	14/91 (15.4%)
Anorectal Pain	6/91 (6.6%)
Anorectal Soreness	12/91 (13.2%)
Anorectal Urge	24/91 (26.4%)
Diarrhea	11/91 (12.1%)
Discomfort	5/91 (5.5%)
Gas	5/91 (5.5%)
General disorders
Device Displacement	21/91 (23.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.