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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-10

Study Completion Date

2016-12-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer for Bowel Dysfunction Following Surgery for Rectal Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Implantation of the InterStimTM

Intervention Type DEVICE

MSK BFI questionnaires

Intervention Type BEHAVIORAL

The Low Anterior Resection Score (LARS) questionnaires

Intervention Type BEHAVIORAL

The EuroQOL5D questionnaires

Intervention Type BEHAVIORAL

The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Implantation of the InterStimTM

Intervention Type DEVICE

MSK BFI questionnaires

Intervention Type BEHAVIORAL

The Low Anterior Resection Score (LARS) questionnaires

Intervention Type BEHAVIORAL

The EuroQOL5D questionnaires

Intervention Type BEHAVIORAL

The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires

Intervention Type BEHAVIORAL

Interventions

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Implantation of the InterStimTM

Intervention Type DEVICE

MSK BFI questionnaires

Intervention Type BEHAVIORAL

The Low Anterior Resection Score (LARS) questionnaires

Intervention Type BEHAVIORAL

The EuroQOL5D questionnaires

Intervention Type BEHAVIORAL

The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No