Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200057
First received: September 12, 2005
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Fecal Incontinence
Device: InterStim Sacral Nerve Stimulation Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    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.


  • Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    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.

  • Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    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.

  • Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
    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.

  • Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 285
Study Start Date: January 2002
Study Completion Date: September 2011
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: InterStim Sacral Nerve Stimulation Therapy
    Open label study. All subjects that qualify for the study will be implanted.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200057

Locations
United States, California
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Los Angeles, California, United States
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San Francisco, California, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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Weston, Florida, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Kansas
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Kansas City, Kansas, United States
United States, Louisiana
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New Orleans, Louisiana, United States
United States, Massachusetts
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Burlington, Massachusetts, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
United States, Ohio
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Cleveland, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Texas
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Fort Worth, Texas, United States
Canada, Quebec
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Fleurimont, Quebec, Canada
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Director: Sudha Iyer, PhD Medtronic
  More Information

Publications:
Responsible Party: Sudha Iyer, Clinical Research Manager, Medtronic
ClinicalTrials.gov Identifier: NCT00200057     History of Changes
Other Study ID Numbers: G010206
Study First Received: September 12, 2005
Results First Received: April 13, 2011
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
Fecal Incontinence
InterStim

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014