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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
Undergo lead removal
Ancillary studies
Ancillary studies
Undergo sacral nerve stimulator implantation
Undergo sacral nerve stimulator battery implantation
Undergo sacral nerve stimulator implantation
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Sacral Nerve Stimulation (SNS) Success
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)
Time frame: Up to visit 3
Fecal Incontinence Severity Index Questionnaire Summary
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
Fecal Incontinence Quality of Life Questionnaire Summary
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
Low Anterior Resection Syndrome Score BFQ
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
Cleveland Clinic Incontinence Score
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
Impact of SNS on Bowel Dysfunction
Will be measured using bowel diaries.
Time frame: Up to 30 days (visit 2)
Impact of SNS on Urinary Incontinence
Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.
Time frame: Up to 30 days (visit 2)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.