A Study of a Neuromodulation Device for Patients with Bowel Dysfunction after Rectal Cancer Surgery

Full Title

Randomized Crossover Study of the Efficacy of Sacral Neuromodulation (SNM) with InterstimTM for Bowel Dysfunction Following Surgery for Low Rectal Cancers with Sphincter Preservation

Purpose

After rectal surgery, some patients experience problems controlling their bowel movements (fecal incontinence) or have other bowel symptoms such as urgency, the feeling of incomplete bowel emptying, or frequent bowel movements. The purpose of this study is to see if a device called Interstim, a form of “sacral neuromodulation,” can help improve bowel function in these patients. The device is implanted in the lower back, near the base of the spine, and electrically stimulates the nerve involved in bowel function — much like a pacemaker.

Patients will be randomly assigned to one of two groups. One group will have four weeks of the device being turned on and then two weeks off, while the other group will have the device off for the first six weeks. During the next four weeks of the study, those in the first group will have the device turned off and those in the second group will have the device turned on, to see if any “placebo effect” is influencing how patients are doing. Then all patients will have the device turned on at the end of the study to a setting that works for them.

Eligibility

This study is for patients (age 18 and older) who had sphincter-preserving surgery for rectal cancer and who are now experiencing problems with their bowel function such as urgency, leakage, incomplete emptying, or frequent bowel movements.

For more information about this study, please contact Dr. Larissa Temple at 212-639-6081.

Protocol

14-100

Phase

II/III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Locations