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Use of Prokinetics During Inpatient Bowel Care for SCI Patients

Phase 1
Waitlist Available
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24months
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this study, we would like to test the applicability of this medication to bowel care routines. The investigators believe that the addition of this medication to the beginning of regular bowel regiments will significantly decrease the time and effort needed to complete BC, thus improving patient perception of their BC routines and quality of life. SCI individuals followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient undergo BC routines assisted by the inpatient care team. BC routines are typically performed every other day, or thrice weekly (Monday, Wednesday, Friday) in "Blue Rooms" located on the inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use of assistive medications or devices, and completeness of bowel care are documented in the patients' electronic medical chart (CPRS) by care providers. The investigators propose to perform the described protocol in individuals who have been admitted to the hospital for routine care and are otherwise healthy. In doing so, the investigators can ensure that patients are vigilantly monitored during each BC session, and that any changes in BC pattern are accurately observed and documented. Furthermore, by performing these procedures on an inpatient basis, study investigators can ensure the consistency of care and daily routine, allowing for better control of study conditions.

Eligible Conditions
  • Bowel Incontinence
  • Neurogenic Bowel
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biological Response to Study Medication (Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed)
Secondary study objectives
Effect of Medication on Impaction (changes in fecal impaction and constipation by documenting weekly weight and pre to post treatment plain abdominal x-ray)
Subjective Feedback from Inpatients (Treatment Satisfaction Questionnaire for Medication (TSQM)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Bowel Evacuation via IVExperimental Treatment1 Intervention
The study design will consist of an intravenous (IV) screening visit to determine each individual's response to neostigmine and glycopyrrolate (NG).
Group II: Bowel Evacuation TitrationExperimental Treatment1 Intervention
This design will consist of a dose titration for those subjects who respond positively to IV. These subjects will receive either a low dose and/or a high dose of NG via iontophoresis to determine their responsiveness.
Group III: Bowel Evacuation IontophoresisExperimental Treatment1 Intervention
This design will consist of the incorporation of iontophoresis administration into clinical bowel care. The subject will receive the exact dose they responded to during the titration 3x per week for 2weeks.

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,860 Total Patients Enrolled
~2 spots leftby Dec 2025