Thrice Weekly Bowel Care

• Status: Recruiting
• Trial end date: 2021-01-14
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Glycopyrrolate; Neostigmine

Criteria

1. Inclusion Criteria:

• Spinal Cord Injury:

• Level of injury C1 to S4

• Duration of injury over 1 year

• Excess time for bowel evacuation (over 60 minutes per bowel training session).

2. Exclusion Criteria:

• Previous Adverse Reaction or Hypersensitivity to Electrical Stimulation

• Do not require additional bowel care or have "normal bowel function"

• Known sensitivity to Neostigmine and Glycopyrrolate

• Blockage in Bowel or Bladder

• Myocardial Infarction in the past 6months

• Blood Pressure over 160 over 100 mg Hg with being on 3 or more different classes of antihypertensive medications

• Organ Damage (heart and kidney) and/or TIA, CVA as a result of hypertension

• Known past history of coronary artery disease, chronic heart failure, bradyarrythmia

• Slow Heart Rate (under 45 bpm)

• Active respiratory diseases

• Known history of asthma during lifetime

• Recent (within 3 months) respiratory infections

• Adrenal Insufficiency

• Pregnancy or potential for pregnancy

• Lactating/nursing females

• Use of any antibiotics in past 7 days

• Use of medications known to affect respiratory system

• Concurrent participation in other clinical trials (within 30 days)