Overview

Thrice Weekly Bowel Care

Status:
Recruiting
Trial end date:
2021-01-14
Target enrollment:
Participant gender:
Summary
c. To measure a baseline for each subject, an abdominal x-ray (KUB) was performed, the SCI Bowel Survey and Treatment Satisfaction Questionnaire (TSQM) were administered and the subject's weight determined. After all the baseline measurements were acquired, the subjects underwent transdermal screening with hair epilation to test their response to transdermal administration of NEO (0.07mg/kg) and GLY (0.014mg/kg). All subjects had a positive response (bowel movement within 60 minutes of drug administration) and received five more cycles of bowel care for two weeks. All subjects reported bowel evacuation during each session and some reported side effects like slight dry mouth, eye twitching, and cramping. These side effects lasted approximately 20-30 minutes in duration and there were no clinically significant changes in cardiopulmonary vital signs. Six subjects after completing two weeks of bowel care had an abdominal x-ray (KUB) done. Also, they were weighted and reassessed using the TSQM and bowel survey.
Phase:
Phase 1
Details
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Treatments:
Glycopyrrolate
Neostigmine