Intranasal Administration of a Prokinetic for Bowel Evacuation in Persons With SCI
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
DWE (difficulty with evacuation) is a common and an important quality of life issue after
spinal cord injury. Not only is the management DWE time-consuming and unpleasant, but the
results are often suboptimal in terms of complications such as incontinence and impaction.
Bowel care regimens after spinal cord injury have not changed in any significant fashion in
many years. The usual strategies for attaining bowel evacuation involve dietary manipulation
(e.g., high fiber diets and hydration), thrice weekly laxative administration (senna and
cascara) and thrice weekly anorectal instillation of cathartics (enemas and suppositories).
Bowel care can be quite time consuming (greater than 2 hours in many instances) and may also
require extensive nursing care. Finally, incomplete evacuation could contribute to fecal
incontinence that has significant morbidity in these patients.
In preliminary studies performed at the JJPVAMC, IV, IM, and subcutaneous injection of
neostigmine combined with glycopyrrolate were demonstrated to be highly effective to promote
bowel evacuation in the SCI population. In an effort to provide a more realistic
administration of this procedure, we propose to test the intranasal spray injection of
neostigmine and glycopyrrolate for safety and efficacy.
Phase:
Phase 2
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development