Fecal IncontinenceNCT01044589
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
A study testing Biodesign Tissue Repair Graft and Overlapping Sphincter Repair in people with Fecal Incontinence and Anal Incontinence, run by Massarat Zutshi at 1 site in United States.
Trial summary
The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence, Anal Incontinence
- What is being tested?
- Biodesign Tissue Repair Graft and Overlapping Sphincter Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18 years or older
- fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
- Fecal incontinence severity score of 10 or more
- Fecal incontinence episodes of 4 or more over a 2 week period
Who cannot join
- History of diabetes
- History of allergy to porcine derivatives
- History of infection in the anal area (abscess, fistula)
- History of inflammatory bowel disease
- History of hidradenitis suppurativa
- History of immunosuppression
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- History of HIV positivity
- History of radiation to the study site within the last 12 months
- Patients who cannot travel to keep follow up appointments
- Patients who are prisoners
- Patients who are mentally handicapped
- Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
- Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
- Patients with a FIQL baseline score of ≤ 4
- Patients participating in another clinical trial for the same indication
- Patients unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.
- Conditions
- Fecal Incontinence, Anal Incontinence
- Being tested
- Biodesign Tissue Repair Graft, Overlapping Sphincter Repair
- Medical subject headings
- Fecal Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodesign Tissue Repair GraftDevice
Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter RepairOther
Overlapping Sphincter Repair Alone
| Study group | Role | What they receive |
|---|---|---|
| Biodesign Tissue Repair Graft | Experimental | Biodesign Tissue Repair Graft Receives: Device: Biodesign Tissue Repair Graft; Other: Overlapping Sphincter Repair |
| Overlapping Sphincter Repair | Active comparator | Control Receives: Other: Overlapping Sphincter Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Measured: 12 months
Secondary outcomes (1)
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: The study was stopped due to low enrollment
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.
- Other trials for Fecal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massarat Zutshi
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Group Incorporated
- Responsible party
- Sponsor-investigator, Massarat Zutshi, The Cleveland Clinic
- Investigators
- Massarat Zutshi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044589
- Sponsor's protocol ID
- 09-008
- Status last verified
- Jul 2017
- First submitted
- 7 Jan 2010
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
- ClinicalTrials.gov ID
- NCT01044589
- Acronym / sponsor ID
- 09-008
- Conditions
- Fecal Incontinence, Anal Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to low enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massarat ZutshiUniversity, hospital or other
- Collaborators
- Cook Group Incorporated
- Study start
- May 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodesign Tissue Repair Graft | Experimental | Device: Biodesign Tissue Repair Graft, Other: Overlapping Sphincter RepairBiodesign Tissue Repair Graft |
| Overlapping Sphincter Repair | Active comparator | Other: Overlapping Sphincter RepairControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Age 18 years or older
- fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
- Fecal incontinence severity score of 10 or more
- Fecal incontinence episodes of 4 or more over a 2 week period
Key exclusion criteria (16 listed)
- History of diabetes
- History of allergy to porcine derivatives
- History of infection in the anal area (abscess, fistula)
- History of inflammatory bowel disease
- History of hidradenitis suppurativa
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 |
|---|---|---|
| Biodesign Tissue Repair GraftBiodesign Tissue Repair Graft reinforcement | Device | Biodesign Tissue Repair Graft |
| Overlapping Sphincter RepairOverlapping Sphincter Repair Alone | Other | Biodesign Tissue Repair Graft, Overlapping Sphincter Repair |
Primary outcome
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time frame: 12 months
1 secondary outcome
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Massarat Zutshi, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodesign Tissue Repair Graft and Overlapping Sphincter Repair in people with Fecal Incontinence and Anal Incontinence, run by Massarat Zutshi at 1 site 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 16 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: stopped early, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 Aug 2017). 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?
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2017.