NCT04066894 · REGISTRY CONDITION SEARCH

Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2023-08-14

This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Sacral Nerve Stimulation (SNS) Success

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outcome · POSTED

Fecal Incontinence Severity Index Questionnaire Summary

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outcome · POSTED

Fecal Incontinence Quality of Life Questionnaire Summary

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outcome · POSTED

Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)

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outcome · POSTED

International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms

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outcome · POSTED

Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)

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outcome · POSTED

Low Anterior Resection Syndrome Score BFQ

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outcome · POSTED

Cleveland Clinic Incontinence Score

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outcome · POSTED

Impact of SNS on Bowel Dysfunction

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outcome · POSTED

Impact of SNS on Urinary Incontinence

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outcome · POSTED

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer * Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation * Cohort 1: Patients treated with restorative surgical resection without radiation * Cohort 1: Patients with any T-stage or N-stage rectal cancer that underwent treatment with radiation and restorative surgery * Cohort 1: Patients with self-reported FI or LARS * Cohort 1: Patients must be at least 18 years old and be able to speak and understand English * Cohort 1: Patients must be willing to and able to sign an approved informed consent document * Cohort 1: Patients must be \>= 24 months post-resection of rectal cancer * Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion * Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery * Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function * Cohort 1: Patients who have an average resting tone \< 40 mmHg (normal \> 40 mmHg) and maximal tolerance \< 200 milliliters (normal 200-300 milliliters) as measured by ARM * Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary) * Cohort 2: Patients treated with standard of care radiation therapies without surgical resection * Cohort 2: Patients with self-reported FI or other defecatory dysfunction * Cohort 2: Patients must be at least 18 years old and be able to speak and understand English * Cohort 2: Patients must be willing to and able to sign an approved informed consent document * Cohort 2: Patients must be \>= 18 months post-pelvic chemoradiation * Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction * Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study * Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function * Cohort 2: Patients who have an average resting tone \< 40 mmHg (normal \> 40 mmHg) and maximal tolerance \< 200 milliliters (normal 200-300 milliliters) as measured by ARM Exclusion Criteria: * Cohort 1: Patients with co-morbid illnesses or concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Cohort 1: Any diverting bowel ostomy at the time of consent to this study * Cohort 1: Patients with an absolute neutrophil count (ANC) \< 1.7 within 30 days of consent * Cohort 1: Patients with an international normalized rate (INR) \> 1.3 within 30 days of consent * Cohort 1: Patients with a platelet count \< 50 K within 30 days of consent * Cohort 1: Patients currently being treated with chemotherapy or within preceding 30 days at the time consent * Cohort 1: Patients previously treated with a SNS for urinary or FI * Cohort 1: Patients who were documented to have an anastomotic leak following their restorative surgical resection * Cohort 1: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status \> 2 at the time of consent * Cohort 1: Patients with an active infection requiring systemic therapy at the time of consent * Cohort 1: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure * Cohort 2: Co-morbid illnesses or other concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Cohort 2: Patients with an ANC \< 1.7 within 30 days of consent * Cohort 2: Patients with an INR \> 1.3 within 30 days of consent * Cohort 2: Patients with a platelet count \< 50 K, within 30 days of consent * Cohort 2: Patients currently being treated with chemotherapy or within the preceding 30 days at the time of consent * Cohort 2: Patients previously treated with a sacral nerve stimulator for urinary or fecal incontinence * Cohort 2: Patients with an ECOG performance status \> 2 at the time of consent * Cohort 2: Patients with an active infection requiring systemic therapy at the time of consent * Cohort 2: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure * Cohort 2: Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
intervention Names
Procedure: Explantation
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Device: Sacral Nerve Stimulator
Device: Sacral Nerve Stimulator Battery
Procedure: Therapeutic Conventional Surgery
label
Supportive Care (sacral nerve stimulator)
type
EXPERIMENTAL

interventions

arm Group Labels
Supportive Care (sacral nerve stimulator)
description
Undergo lead removal
name
Explantation
type
PROCEDURE
arm Group Labels
Supportive Care (sacral nerve stimulator)
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER
arm Group Labels
Supportive Care (sacral nerve stimulator)
description
Ancillary studies
name
Questionnaire Administration
type
OTHER
arm Group Labels
Supportive Care (sacral nerve stimulator)
description
Undergo sacral nerve stimulator implantation
name
Sacral Nerve Stimulator
other Names
Sacral Neuromodulator
type
DEVICE
arm Group Labels
Supportive Care (sacral nerve stimulator)
description
Undergo sacral nerve stimulator battery implantation
name
Sacral Nerve Stimulator Battery
other Names
Sacral Neuromodulator Battery
type
DEVICE
arm Group Labels
Supportive Care (sacral nerve stimulator)
description
Undergo sacral nerve stimulator implantation
name
Therapeutic Conventional Surgery
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)
measure
Sacral Nerve Stimulation (SNS) Success
time Frame
Up to visit 3

secondary Outcomes

description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
Fecal Incontinence Severity Index Questionnaire Summary
time Frame
Up to 3 years
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
Fecal Incontinence Quality of Life Questionnaire Summary
time Frame
Up to 3 years
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)
time Frame
Up to 3 years
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms
time Frame
Up to 3 years
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)
time Frame
Up to 3 years
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
Low Anterior Resection Syndrome Score BFQ
time Frame
Up to 3 years
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
Cleveland Clinic Incontinence Score
time Frame
Up to 3 years
description
Will be measured using bowel diaries.
measure
Impact of SNS on Bowel Dysfunction
time Frame
Up to 30 days (visit 2)
description
Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.
measure
Impact of SNS on Urinary Incontinence
time Frame
Up to 30 days (visit 2)
description
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
measure
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29
time Frame
Up to 3 years

Full study description

brief Summary: This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.
detailed Description: PRIMARY OBJECTIVES: I. To investigate the efficacy of sacral nerve stimulator placement in patients with fecal incontinence (FI) or low anterior resection syndrome (LARS) who have previously undergone chemoradiation treatment (XRT) and/or a restorative partial or complete proctectomy with colorectal or coloanal anastomosis for cancer treatment as per standard of care (restorative surgery cohort). II. To evaluate the feasibility of sacral nerve stimulator placement in patients with fecal incontinence (FI) or other defecatory dysfunction who have received pelvic radiation treatment without undergoing rectal or other pelvic surgery as per standard of cancer care (radiation only cohort). SECONDARY OBJECTIVES: I. To evaluate the effectiveness of sacral nerve stimulation (SNS) as measured by validated questionnaires in patients with FI or LARS within both patient cohorts. II. To evaluate pelvic floor and sphincter physiology using anorectal manometry (ARM) before and after SNS in patients with FI or LARS within both patient cohorts. III. To assess potential impact of SNS on urinary incontinence measuring a post-void urinary bladder residual and validated urinary symptom questionnaires in both patient cohorts. IV. To assess efficacy of SNS on long-term bowel dysfunction at 1 and 3 years post battery implantation as measured by validated questionnaires for both patient cohorts. OUTLINE: Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads. After completion of study, patients are followed up at 1 month, 1 year, and 3 years.

Source references