Bowel IncontinenceRESTNCT01475474

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

A study testing Renew Insert in people with Bowel Incontinence, run by Renew Medical at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bowel Incontinence
What is being tested?: Renew Insert
Type of treatment: Medical device
How many people: 97 participants
Where: 3 sitesUnited States
Study dates: Dec 2009to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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 locations and contacts

3 sites in 1 country.

United States3 sites

Dr. Segall
Los Gatos, California, 95032
UCSD Medical Center
San Diego, California, 92103-8897
Cleveland Clinic Florida
Weston, Florida, 33331

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Bowel Incontinence
Being tested: Renew Insert
Keywords: incontinence, bowel, movement, fecal, anal, diarrhea, stool, rectal, feces, uncontrolled, loose, leakage, rectum, BM, watery, urgent, flatulence, gas
Medical subject headings: Fecal Incontinence, Diarrhea, Flatulence, Mucopolysaccharidosis IV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Renew InsertDevice
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).
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).
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Dec 2011

First posted21 Nov 2011 (estimated)
Study startDec 2009
Primary completionNov 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bowel IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01475474
Sponsor's protocol ID: Renew Medical - 210CLD
Acronym: REST
Status last verified: Sep 2013
First submitted: 10 Nov 2011
Last updated: 28 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26252852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)

All Bowel Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01475474
Acronym / sponsor ID: REST / Renew Medical - 210CLD
Conditions: Bowel Incontinence
Keywords: incontinence, bowel, movement, fecal, anal, diarrhea, stool, rectal
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Renew MedicalIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Nov 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 21 Nov 2011 (estimated)
Results: Posted 28 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Renew InsertThe 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.	Device	–

Primary outcome

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.
Time frame: 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.
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).
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).

Results and safety

Results posted to the registry on 28 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Renew Insert for Management of Accidental Bowel Leakage	97	91

Primary outcome: 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.

Time frame: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).. Median (Inter-Quartile Range). Unit: percentage change

Measure	Modified Intent-To-Treat Cohort n = 85
Value	-81.8 (-91.7 to -60.3)

Modified Intent-To-Treat Cohort: p <0.001, Wilcoxon Signed-Rank Test

Population analysed: 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.

Primary outcome: 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.

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).. Median (Inter-Quartile Range). Unit: Percentage change

Measure	Modified Intent to Treat Cohort (MITT) n = 77
Value	-29.4 (-46.2 to 13.3)

Modified Intent to Treat Cohort (MITT): p <0.001, Wilcoxon Signed-Rank Test

Adverse events

Time frame: Adverse events were collected on all subjects who used a Renew Insert through the end of study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intent-to-treat (ITT) Cohort	0 of 91 (0%)	91 of 91 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26252852Lukacz 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.

Related trials for Bowel Incontinence

Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Active, not recruiting
F15 Recharge Free Axonics SNM System Clinical Study
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
RecruitingObservational study
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Fecal Incontinence
Recruiting
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven D Wexner, MD principal investigator

Cleveland Clinic Florida

Emily Lukacz, MD principal investigator

University of California, San Diego, CA

Mark Segall, MD principal investigator

The medical office of Mark Segall MD

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Renew Insert in people with Bowel Incontinence, run by Renew Medical at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01475474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.