Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Pat… (NCT04066894) | Clinical Trial Compass
TerminatedPhase 2
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
Stopped: Due to Issues Enrolling Patients
United States3 participantsStarted 2019-04-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: Patient…