N/A
Completed N=97
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
Bowel Incontinence
Source: ClinicalTrials.gov NCT01475474 ↗
Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: 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 — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | <0.001 sig |
| PRIMARY 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 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01475474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.