Bowel Incontinence
Conditions
Keywords
incontinence, bowel, movement, fecal, anal, diarrhea, stool, rectal, feces, uncontrolled, loose, leakage, rectum, BM, watery, urgent, flatulence, gas
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.
Interventions
DEVICERenew Insert
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.
Sponsors
Renew Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16). | 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) |
| 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. | 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). | 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). |
Countries
United States
Participant flow
Recruitment details
Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period. The study started in December 2009 and completed in December 2011.
Pre-assignment details
Renew Medical conducted a multi-center, prospective, open label, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to severe bowel incontinence (defined as having a Wexner score greater than 12).
Participants by arm
| Arm | Count |
|---|---|
| Renew Insert for Management of Accidental Bowel Leakage | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline Period - 4 Weeks | Did not meet eligibility for treatment | 4 |
| Baseline Period - 4 Weeks | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Renew Insert for Management of Accidental Bowel Leakage |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 63 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 91 / 91 |
| serious Total, serious adverse events | 0 / 91 |
Outcome results
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.
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).
Population: Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Modified Intent-To-Treat Cohort | 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 |
Comparison: Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zerop-value: <0.001Wilcoxon Signed-Rank Test
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.
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).
Population: Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Modified Intent-To-Treat Cohort | 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 Percentage change |
Comparison: Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner scorep-value: <0.001Wilcoxon Signed-Rank Test