N/A
N=120
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00200057 ↗Enrolled (actual)
120
Serious AEs
34.2%
Results posted
Aug 2011
Primary outcome: Primary: Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week — 0.73 proportion of subjects — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- InterStim Sacral Nerve Stimulation Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week |
0.73 | <0.0001 sig |
| SECONDARY Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week |
0.73 | <0.0001 sig |
| SECONDARY Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle |
0.92 | <0.0001 sig |
| SECONDARY Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior |
1.12 | <0.0001 sig |
| SECONDARY Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception |
0.86 | <0.0001 sig |
| SECONDARY Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment |
1.06 | <0.0001 sig |
| SECONDARY Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week |
0.71 | <0.0001 sig |
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 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.
Data sourced from ClinicalTrials.gov (NCT00200057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.