Clinical trial NCT00200057: Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Official title: Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal Incontinence
InterStim
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
timeFrame: Baseline and 12 months
measure: Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
timeFrame: Baseline and 12 months
measure: Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
timeFrame: Baseline and 12 Months
measure: Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
timeFrame: Baseline and 12 Months
measure: Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
timeFrame: Baseline and 12 Months
measure: Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Contact Medtronic for specific site information
state: California
city: San Francisco
country: United States
facility: Contact Medtronic for specific site information
state: California
city: Washington
country: United States
facility: Contact Medtronic for specific site information
state: District of Columbia
city: Weston
country: United States
facility: Contact Medtronic for specific site information
state: Florida
city: Chicago
country: United States
facility: Contact Medtronic for specific site information
state: Illinois
city: Kansas City
country: United States
facility: Contact Medtronic for specific site information
state: Kansas
city: New Orleans
country: United States
facility: Contact Medtronic for specific site information
state: Louisiana
city: Burlington
country: United States
facility: Contact Medtronic for specific site information
state: Massachusetts
city: Minneapolis
country: United States
facility: Contact Medtronic for specific site information
state: Minnesota
city: Cleveland
country: United States
facility: Contact Medtronic for specific site information
state: Ohio
city: Oklahoma City
country: United States
facility: Contact Medtronic for specific site information
state: Oklahoma
city: Fort Worth
country: United States
facility: Contact Medtronic for specific site information
state: Texas
city: Fleurimont
country: Canada
facility: Contact Medtronic for specific site information
state: Quebec
Study officials:
affiliation: Medtronic
name: Sudha Iyer, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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 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.