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Neurotransmitter Agents

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.

Explantation

Quality-of-Life Assessment

Questionnaire Administration

Undergo sacral nerve stimulator implantation

Sacral Nerve Stimulator

Undergo sacral nerve stimulator battery implantation

Sacral Nerve Stimulator Battery

Therapeutic Conventional Surgery

Craig A Messick, MD

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.

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.

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

A Phase II Study of Sacral Nerve Stimulation for Low Anterior Resection Syndrome or Fecal Incontinence in Patients Following a Low Anterior Resection or Proctectomy With Coloanal Anastomosis or in Patients After Pelvic Chemoradiation (RESTORE)

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)

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Experimental: Sacral Nerve Stimulation (SNS)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Craig Messick

Sacral Nerve Stimulation (SNS) Success

Fecal Incontinence Severity Index Questionnaire Summary

Fecal Incontinence Quality of Life Questionnaire Summary

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

International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms

Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)

Low Anterior Resection Syndrome Score BFQ

Cleveland Clinic Incontinence Score

Impact of SNS on Bowel Dysfunction

Impact of SNS on Urinary Incontinence

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

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT04066894	Low Anterior Re... Malignant Anal ... Malignant Bladd... Malignant Cervi... Malignant Ovari... Malignant Pelvi... Malignant Prost... Malignant Uteri... Malignant Vagin... Malignant Vulva... Rectal Carcinom...	Explantation Quality-of-Life... Questionnaire A... Sacral Nerve St... Sacral Nerve St... Therapeutic Con...	18 Years -	M.D. Anderson Cancer Center
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	NCT04066894	Low Anterior Re... Malignant Anal ... Malignant Bladd... Malignant Cervi... Malignant Ovari... Malignant Pelvi... Malignant Prost... Malignant Uteri... Malignant Vagin... Malignant Vulva... Rectal Carcinom...	Explantation Quality-of-Life... Questionnaire A... Sacral Nerve St... Sacral Nerve St... Therapeutic Con...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for malignant vulvar neoplasm