Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Public ClinicalTrials.gov record NCT00200057. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00200057
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 285 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2001
- Primary completion
- Jul 31, 2007
- Completion
- Aug 31, 2011
- Last update posted
- Jan 23, 2013
2002 – 2011
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Contact Medtronic for specific site information | Los Angeles | California | — | — |
| 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 | — | — |
| Contact Medtronic for specific site information | Chicago | Illinois | — | — |
| Contact Medtronic for specific site information | Kansas City | Kansas | — | — |
| Contact Medtronic for specific site information | New Orleans | Louisiana | — | — |
| Contact Medtronic for specific site information | Burlington | Massachusetts | — | — |
| Contact Medtronic for specific site information | Minneapolis | Minnesota | — | — |
| Contact Medtronic for specific site information | Cleveland | Ohio | — | — |
| Contact Medtronic for specific site information | Oklahoma City | Oklahoma | — | — |
| Contact Medtronic for specific site information | Fort Worth | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00200057, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 23, 2013 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00200057 live on ClinicalTrials.gov.