Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200057
• Other study ID #: G010206
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 17, 2013
• Start date: January 2002
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: September 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• InterStim Sacral Nerve Stimulation Therapy
Open label study. All subjects that qualify for the study will be implanted.

Locations

Country	Name	City	State
Canada	Contact Medtronic for specific site information	Fleurimont	Quebec
United States	Contact Medtronic for specific site information	Burlington	Massachusetts
United States	Contact Medtronic for specific site information	Chicago	Illinois
United States	Contact Medtronic for specific site information	Cleveland	Ohio
United States	Contact Medtronic for specific site information	Fort Worth	Texas
United States	Contact Medtronic for specific site information	Kansas City	Kansas
United States	Contact Medtronic for specific site information	Los Angeles	California
United States	Contact Medtronic for specific site information	Minneapolis	Minnesota
United States	Contact Medtronic for specific site information	New Orleans	Louisiana
United States	Contact Medtronic for specific site information	Oklahoma City	Oklahoma
United States	Contact Medtronic for specific site information	San Francisco	California
United States	Contact Medtronic for specific site information	Washington	District of Columbia
United States	Contact Medtronic for specific site information	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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 — View Citation

Wexner 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 tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 12 months	No
Secondary	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.	Baseline and 12 months	No
Secondary	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.	Baseline and 12 months	No
Secondary	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.	Baseline and 12 Months	No
Secondary	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.	Baseline and 12 Months	No
Secondary	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.	Baseline and 12 Months	No
Secondary	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.	Baseline and 12 months	No