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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    60
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 23 January 2021
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Summary

This 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.

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 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.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Rectal disorder, Rectal Disorders, Uterine Cancer, Uterine Cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, Ovarian Cancer, Ovarian Cancer, Recurrent Ovarian Cancer, Malignant neoplasm of vulva, Fecal Incontinence, Fecal Incontinence, Vaginal Cancer, Vaginal Cancer, Prostate Cancer, Early, Recurrent, Rectal Disorders, Rectal Adenocarcinoma, Urothelial Cancer, Recurrent Ovarian Cancer, Adenocarcinoma of Rectum, Low Anterior Resection Syndrome, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8, Prostate Cancer, Pelvic Cancer, Bladder Carcinoma, Stage IV Rectal Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8, Stage IVC Rectal Cancer AJCC v8, Malignant Pelvic Neoplasm, bowel incontinence, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, vulva cancer, prostate cancers, Malignant Anal Neoplasm, Malignant Cervical Neoplasm
Treatment questionnaire administration, quality-of-life assessment, therapeutic conventional surgery, Explantation, Sacral Nerve Stimulator, Sacral Nerve Stimulator Battery
Clinical Study IdentifierNCT04066894
SponsorM.D. Anderson Cancer Center
Last Modified on23 January 2021

Eligibility

 Yes No Not Sure

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 with T1 and T2 pathologic stage patients treated with restorative surgical resection without radiation
Cohort 1: Patients with locally advanced rectal adenocarcinoma (T3 and T4 or lymph node positive) treated with radiation and restorative surgery
Cohort 1: Patients with self-reported FI or LARS
Cohort 1: Patients must 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 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
Cohort 2: Patients who are human immunodeficiency virus (HIV) positive (+) or have hepatitis B or C remain eligible, however, HIV+ patients must have a CD4 T cell count > 200 cells per microliter
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