Trial Outcomes & Findings for Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation (NCT NCT02163187)

Last Updated: 2018-02-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

4 participants

Primary outcome timeframe

3 years

Results posted on

2018-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	InterStimTM the Device on, Then InterStimTM Device Off 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. Implantation of the InterStimTM MSK BFI questionnaires The Low Anterior Resection Score (LARS) questionnaires The EuroQOL5D questionnaires The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires	InterStimTM the Device Off, Then InterStimTM Device on 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. Implantation of the InterStimTM MSK BFI questionnaires The Low Anterior Resection Score (LARS) questionnaires The EuroQOL5D questionnaires The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires
Overall Study STARTED	4	0
Overall Study Treatment	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	InterStimTM the Device on, Then InterStimTM Device Off 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. Implantation of the InterStimTM MSK BFI questionnaires The Low Anterior Resection Score (LARS) questionnaires The EuroQOL5D questionnaires The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires	InterStimTM the Device Off, Then InterStimTM Device on 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. Implantation of the InterStimTM MSK BFI questionnaires The Low Anterior Resection Score (LARS) questionnaires The EuroQOL5D questionnaires The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires
Overall Study Device removed	1	0
Overall Study Progressive disease	1	0

Baseline Characteristics

2 participants were evaluable. 2 participants were non-evaluable.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InterStimTM the Device on, Then InterStim TM the Device Off n=4 Participants 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.	InterStimTM the Device Off, Then InterStim the Device on 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. No participants were accrued to this arm before the study was closed.	Total n=4 Participants Total of all reporting groups
Age, Continuous	53 years n=93 Participants	—	53 years n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants • 2 participants were evaluable. 2 participants were non-evaluable.	—	3 Participants n=27 Participants • 2 participants were evaluable. 2 participants were non-evaluable.
Sex: Female, Male Male	1 Participants n=93 Participants • 2 participants were evaluable. 2 participants were non-evaluable.	—	1 Participants n=27 Participants • 2 participants were evaluable. 2 participants were non-evaluable.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants	—	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	—	4 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Region of Enrollment United States	4 Participants n=93 Participants	—	4 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Study terminated early due to low accrual. Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: Study terminated early due to low accrual. Data were not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

InterStimTM the Device on

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

InterStimTM the Device Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martin Weister, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-6698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place