Status:
COMPLETED
Use of a Prokinetic Agent as an Adjunct to Thrice Weekly Bowel Care After SCI
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Spinal Cord Injuries
Constipation
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 determin...
Detailed Description
Part 1: IV Screening Twenty subjects with chronic SCI (\>1 year) and difficulty with evacuation (DWE) managed by a regular, thrice weekly bowel care (BC) routines will be recruited for study participa...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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)
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04671030
Start Date
January 15 2018
End Date
June 3 2021
Last Update
December 30 2021
Active Locations (1)
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1
James J Peters VA Medical Center
The Bronx, New York, United States, 10468