Fecal IncontinenceNCT00200057
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
A study testing InterStim Sacral Nerve Stimulation Therapy in people with Fecal Incontinence, run by MedtronicNeuro at 13 sites in 2 countries.
Trial summary
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- InterStim Sacral Nerve Stimulation Therapy
- Type of treatment
- Medical device
- How many people
- 285 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2002to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent.
- 18 years of age or older.
- Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (>12 months post-vaginal childbirth) and defined as > 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.
- Failed or are not candidates for more conservative treatments.
- Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.
Who cannot join
- Congenital anorectal malformations.
- Active participation in another bowel disorder investigational study.
- Present rectal prolapse.
- Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done < 12 months prior to study enrollment (24 months for cancer).
- Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).
- Grade III hemorrhoids.
Show all 18Show fewer
- Known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).
- Chronic watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. (Incontinent episodes with a Bristol stool consistency of > 6 for > 4 days during the baseline diary period will be exclusionary, unless the investigator determines that the diary is not indicative of chronic watery diarrhea.)
- Pregnancy or planned pregnancy.
- Patients for whom patient materials are not available in a language understood by the patient.
- Life expectancy of less than one year.
- Patient characteristics indicating a poor understanding of the study or poor compliance with the study protocol (i.e., patients unable to adequately operate equipment, patients unwilling or unable to return for scheduled follow-up visits).
- Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.
- Patients with active anal abscesses or fistulas.
- Patients with anatomical limitations that would prevent the successful placement of an electrode.
- Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.
- Patients with other implantable neurostimulators, pacemakers or defibrillators.
- Defect of external anal sphincter of >60 degrees or amenable to surgical repair.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Contact Medtronic for specific site information
Burlington, Massachusetts
Contact Medtronic for specific site information
Chicago, Illinois
Contact Medtronic for specific site information
Cleveland, Ohio
Contact Medtronic for specific site information
Fort Worth, Texas
Contact Medtronic for specific site information
Kansas City, Kansas
Contact Medtronic for specific site information
Los Angeles, California
Contact Medtronic for specific site information
Minneapolis, Minnesota
Contact Medtronic for specific site information
New Orleans, Louisiana
Contact Medtronic for specific site information
Oklahoma City, Oklahoma
Contact Medtronic for specific site information
San Francisco, California
Contact Medtronic for specific site information
Washington D.C., District of Columbia
Contact Medtronic for specific site information
Weston, Florida
Canada1 site
Contact Medtronic for specific site information
Fleurimont, Quebec
About this study
Official title: Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating.
If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.
- Conditions
- Fecal Incontinence
- Being tested
- InterStim Sacral Nerve Stimulation Therapy
- Keywords
- Fecal Incontinence, InterStim
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim Sacral Nerve Stimulation TherapyDevice
Open label study. All subjects that qualify for the study will be implanted.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."
The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.
Measured: Baseline and 12 months
Secondary outcomes (6)
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered "successes."
The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months.
Measured: Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Measured: Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Measured: Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Measured: Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
Measured: Baseline and 12 Months
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes."
The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionAug 2007
- Study completionSep 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 (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sudha Iyer, PhD, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200057
- Sponsor's protocol ID
- G010206
- Status last verified
- Jan 2013
- First submitted
- 12 Sep 2005
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.
PubMed 20160636Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010 Jul;14(7):1081-9. doi: 10.1007/s11605-010-1177-z. Epub 2010 Mar 31.
PubMed 20354809
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
- ClinicalTrials.gov ID
- NCT00200057
- Acronym / sponsor ID
- G010206
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence, InterStim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 30 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating.
If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent.
- 18 years of age or older.
- Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (>12 months post-vaginal childbirth) and defined as > 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.
- Failed or are not candidates for more conservative treatments.
- Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.
Key exclusion criteria (18 listed)
- Congenital anorectal malformations.
- Active participation in another bowel disorder investigational study.
- Present rectal prolapse.
- Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done < 12 months prior to study enrollment (24 months for cancer).
- Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).
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 |
|---|---|---|
| InterStim Sacral Nerve Stimulation TherapyOpen label study. All subjects that qualify for the study will be implanted. | Device | – |
Primary outcome
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
Time frame: Baseline and 12 months
The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes." The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.
6 secondary outcomes
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
Time frame: Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
Time frame: Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
Time frame: Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
Time frame: Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
Time frame: Baseline and 12 Months
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20160636Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.
- Results publication: PubMed 20354809Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010 Jul;14(7):1081-9. doi: 10.1007/s11605-010-1177-z. Epub 2010 Mar 31.
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
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.
Sudha Iyer, PhD study director
Medtronic
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterStim Sacral Nerve Stimulation Therapy in people with Fecal Incontinence, run by MedtronicNeuro at 13 sites in 2 countries.
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 18 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 30 Aug 2011). 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?
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week (time frame: Baseline and 12 months). 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 NCT00200057, which also lists 2 linked publications.
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 24 Jan 2013.