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

Bowel Incontinence Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Incontinence
• Fecal Incontinence

• NCT number: NCT01475474
• Study type: Interventional
• Source: Renew Medical
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Completion date: December 2011