Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage (NCT NCT01475474)

Last Updated: 2013-11-28

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

97 participants

Primary outcome timeframe

Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).

Results posted on

2013-11-28

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Renew Insert for Management of Accidental Bowel Leakage 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.
Baseline Period - 4 Weeks STARTED	97
Baseline Period - 4 Weeks COMPLETED	91
Baseline Period - 4 Weeks NOT COMPLETED	6
Treatment Period - 12 Weeks STARTED	91
Treatment Period - 12 Weeks COMPLETED	73
Treatment Period - 12 Weeks NOT COMPLETED	18
Return to Baseline Period - 4 Weeks STARTED	73
Return to Baseline Period - 4 Weeks COMPLETED	71
Return to Baseline Period - 4 Weeks NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Renew Insert for Management of Accidental Bowel Leakage 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.
Baseline Period - 4 Weeks Did not meet eligibility for treatment	4
Baseline Period - 4 Weeks Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renew Insert for Management of Accidental Bowel Leakage n=97 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	63 Participants n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants

PRIMARY outcome

Timeframe: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).

Population: 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.

Outcome measures

Outcome measures
Measure	Modified Intent-To-Treat Cohort n=85 Participants Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
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.	-81.8 percentage change Interval -91.7 to -60.3

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Modified Intent-To-Treat Cohort n=77 Participants Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
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.	-29.4 Percentage change Interval -46.2 to 13.3

Adverse Events

Intent-to-treat (ITT) Cohort

Serious events: 0 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intent-to-treat (ITT) Cohort n=91 participants at risk Subjects who used the Renew Insert.
Gastrointestinal disorders Abdominal Pain	5.5% 5/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Accidental Bowel Leakage	5.5% 5/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Anorectal Bleeding	8.8% 8/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Anorectal Irritation	15.4% 14/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Anorectal Pain	6.6% 6/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Anorectal Soreness	13.2% 12/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Anorectal Urge	26.4% 24/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Diarrhea	12.1% 11/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Discomfort	5.5% 5/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
Gastrointestinal disorders Gas	5.5% 5/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.
General disorders Device Displacement	23.1% 21/91 • Adverse events were collected on all subjects who used a Renew Insert through the end of study.

Additional Information

Victoria Mackinnon, Vice President, Regulatory, Clinical & Quality

Renew Medical, Inc.

Phone: 1-888-987-2929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER