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

Renew Medical

Status: Completed

Conditions: Bowel Incontinence

Treatments: Device: Renew Insert

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475474

Renew Medical - 210CLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)