Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
Public ClinicalTrials.gov record NCT02163187. 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
Randomized Crossover Study of the Efficacy of Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation. InterStimTM is FDA approved to help people who have a hard time controlling their bowl movements. This is called fecal incontinence.The device is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is initially tested to make sure it will work using a temporary wire and then, if successful, the device is permanently implanted.
Study identification
- NCT ID
- NCT02163187
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 4 participants
Conditions and interventions
Interventions
- Implantation of the InterStimTM Device
- MSK BFI questionnaires Behavioral
- The Low Anterior Resection Score (LARS) questionnaires Behavioral
- The EuroQOL5D questionnaires Behavioral
- The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires Behavioral
Device · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2014
- Primary completion
- Dec 18, 2016
- Completion
- Dec 18, 2016
- Last update posted
- Feb 4, 2018
2014 – 2016
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Weill Medical College of Cornell University | New York | New York | 10065 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02163187, 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 Feb 4, 2018 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02163187 live on ClinicalTrials.gov.