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

January 10, 2018 updated by: Memorial Sloan Kettering Cancer Center

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a single-blind randomized crossover study. After providing written informed consent, eligible patients will undergo an initial stimulation procedure with a temporary lead (Step 1 Wire Stimulation). The simulation is performed to determine efficacy of the device before a permanent implant is placed. This stimulation takes place over a period of 7-14 days (+/-3 days). Because this procedure is done in the OR, this window of time allows for optimization of the device and coordination of operating room schedules. This is the time period that has been used in prior trials. Typically bowel improvement has been seen relatively quickly, so the range should not affect our assessment of BFI.

After the Wire Implantation has occurred, patients will be evaluated over the next 7-14 days (+/- 3 days) and will complete the BFI questionnaire. If BFI improvement is < than or = to 4 points the wire will be removed in the operating room, the patient will be offered standard of care, and the patient will no longer be part of the study. Based on our prior data, we would like to give as many patients as possible the opportunity for enrollment and as a result we have chosen a 4 point BFI change as minimum criteria for response. Our group has seen that a change in the BFI around 5-6 is clinically significant, but we will lower this threshold slightly. If a patient's BFI improves by ≥ 4 points, the patient will proceed to the randomized phase (Step 2-Implantation) of the study.

Patients who proceed to Step 2- Implantation, they will return to the operating room for the implantation of the permanent device. While in the operating room they will be randomly assigned to either having the device stimulation on (Group A) or device stimulation off (Group B) for first 4 weeks (+/-3 days). Patients will return to clinic 2 weeks later to cross over to the other arm (Step 3-Crossover) and the device stimulation will be set to on or off. Patients will come back to clinic within 7 days (+/- 7 days) after Crossover for device check and optimization.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: InterStimTM the device on
The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.
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
Experimental: InterStimTM the device off
The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bowel Function
Time Frame: 3 years
Bowel function will be assessed by using the MSK BFI. We have chosen the BFI because it is widely endorsed to assess the clinical problem that these patients have. The BFI is a 19 item instrument to which a patient responds using a 5-point Likert scale, ranging from Always to Never.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 3 years
QOL and urinary continence will be assessed at the start of the study (Baseline), after initial stimulation (Step 1-Wire Stimulation), and at each point in the crossover trial (Step 2-Implantation and Step 3-Crossover). Graphical displays will be used to explore data distributions of all secondary outcome measures over time. We assume no period effect and will evaluate the treatment effect using the paired t-test (and a repeated measures ANOVA to include other covariates in the model) for each of our main outcome measures, EuroQOL5, FIQOL, LARS and Bladder function. We will test for period effect to confirm this.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Larissa Temple, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 10, 2014

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

December 19, 2016

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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