Clinical trial NCT01475474: A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Incontinence
Keywords: incontinence
bowel
movement
fecal
anal
diarrhea
stool
rectal
feces
uncontrolled
loose
leakage
rectum
BM
watery
urgent
flatulence
gas
Lead sponsor: Renew Medical
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).
measure: 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.
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).
Secondary outcomes:
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Dr. Segall
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Steven D Wexner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego, CA
name: Emily Lukacz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The medical office of Mark Segall MD
name: Mark Segall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Florida
name: Eric G Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lukacz ES, Segall MM, Wexner SD. Evaluation of an Anal Insert Device for the Conservative Management of Fecal Incontinence. Dis Colon Rectum. 2015 Sep;58(9):892-8. doi: 10.1097/DCR.0000000000000427.