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Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

NCT02163187 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-02-05

Study results available
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Summary

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.

Conditions

  • Rectal Cancer
  • for Bowel Dysfunction Following Surgery for Rectal Cancers

Interventions

DEVICE

Implantation of the InterStimTM

BEHAVIORAL

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

Sponsors & Collaborators

Principal Investigators

  • Larissa Temple, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-10
Primary Completion
2016-12-19
Completion
2016-12-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02163187 on ClinicalTrials.gov