Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
Stopped early · Phase 2/Phase 3
Conditions studied: Rectal Cancer, for Bowel Dysfunction Following Surgery for Rectal Cancers
In brief
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.
Key facts
- Study ID
- NCT02163187
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 4
- Starts
- 2014-06-10
- Expected to finish
- 2016-12-19
- Last updated by the study team
- 2018-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of rectal cancer or neoplastic polyp (i.e. intramucosal carcinoma, carcinoma in situ)
- BFI score must meet at least one of the below criteria:
- Total BFI < 50
- Dietary subscale < 11
- Frequency subscale < 19
- Urgency subscale < 12
- English speaking
- Patients ≥18 years old. age
- Sphincter-preserving surgery and ≥ 12 months after restoration of bowel continuity
You may not qualify if…
- Locally recurrent or metastatic disease
- Immune suppressive medication
- Seizure disorder
- Prior sacral/lower spinal surgery
- Congenital Spinal defect/Paraplegia
- Rectal prolapse
- IBD/Crohn's
- Pregnancy
- Active anal/rectal abscess
- Pacemaker or other electronic implanted device
- Immediate need for MRI
- At the time of the wire stimulation procedure, patients will be excluded if the surgeon is unable to place the temporary stimulating lead
- Inability to commit to local follow up for device management.
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Weill Medical College of Cornell University — New York, New York, United States
Full record on ClinicalTrials.gov
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