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

Renew Medical97 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bowel Incontinence

Interventions

Renew InsertDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Dr. Segall

Los Gatos, California, United States

UCSD Medical Center

San Diego, California, United States

Cleveland Clinic Florida

Weston, Florida, United States

Outcomes

Primary Outcomes

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)

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

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).

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).

Data from ClinicalTrials.gov

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