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Clinical Trial
. 2018 Mar;56(3):212-217.
doi: 10.1038/s41393-017-0018-2. Epub 2017 Nov 8.

Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury

Mark A Korsten  1   2   3 , Brian L Lyons  4 , Miroslav Radulovic  4   5 , Tradd M Cummings  4 , Gautam Sikka  5   6 , Kamaldeep Singh  4   5 , Joshua C Hobson  4 , Anton Sabiev  4 , Ann M Spungen  4   6   7 , William A Bauman  4   5   6   7
Affiliations
Clinical Trial

Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury

Mark A Korsten et al. Spinal Cord. 2018 Mar.

Abstract

Study design: Phase I Clinical Trial.

Objectives: In this proof-of-principle study, the effectiveness and safety of transdermal administration of neostigmine/glycopyrrolate to elicit a bowel movement was compared to intravenous administration in patients with spinal cord injury.

Setting: James J. Peters Veterans Affairs Medical Center (Bronx, NY).

Methods: Individuals were screened for responsiveness (Physical Response) to intravenous neostigmine (0.03 mg/kg)/glycopyrrolate (0.006 mg/kg). Intravenous neostigmine/glycopyrrolate responders (Therapeutic Response) were administered low-dose transdermal neostigmine/glycopyrrolate [(0.05 mg/kg)/(0.01 mg/kg)] by iontophoresis. Non-responders to low-dose transdermal neostigmine/glycopyrrolate were administered high-dose transdermal neostigmine/glycopyrrolate [(0.07 mg/kg)/(0.014 mg/kg)] by iontophoresis. Bowel movement, bowel evacuation time, and cholinergic side effects were recorded. Visits were separated by 2 to 14 days.

Results: Eighteen of 25 individuals (72.0%) had a bowel movement (20 ± 22 min) after intravenous neostigmine/glycopyrrolate. Of these 18 individuals, 5 individuals experienced a bowel movement with low-dose transdermal neostigmine/glycopyrrolate. Another five individuals had a bowel movement after high-dose transdermal neostigmine/glycopyrrolate administration. Fewer side effects were observed in individuals who received neostigmine/glycopyrrolate transdermally compared to those who were administered intravenous neostigmine/glycopyrrolate.

Conclusions: Transdermal administration of neostigmine/glycopyrrolate by iontophoresis appears to be a practical, safe, and effective approach to induce bowel evacuation in individuals with spinal cord injury.

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Conflict of interest statement

Conflicts of Interest:

Drs. Mark Korsten and William Bauman are co-inventors of this bowel intervention and have processed a patent (patent number: 7.635,709) and a provisional patent (62/2984,874) for the administration of neostigmine and glycopyrrolate via iontophoresis through the Office of Technology Transfer Program, Department of Veterans Affairs.

Figures

Figure 1
Figure 1. Study Flow Diagram
Depiction of subject response and study progression. IV = Intravenous; NEO = Neostigmine; GLY = Glycopyrrolate; BM = Bowel Movement
See this image and copyright information in PMC

References

    1. Fajardo NR, Pasiliao RV, Modeste-Duncan R, Creasey G, Bauman WA, Korsten MA. Decreased colonic motility in persons with chronic spinal cord injury. Am J Gastroenterol. 2003;98(1):128–34. - PubMed
    1. Altaf MA, Sood MR. The nervous system and gastrointestinal function. Dev Disabil Res Rev. 2008;14(2):87–95. - PubMed
    1. Korsten MA, Rosman AS, Ng A, Cavusoglu E, Spungen AM, Radulovic M, et al. Infusion of neostigmine-glycopyrrolate for bowel evacuation in persons with spinal cord injury. Am J Gastroenterol. 2005;100(7):1560–5. - PubMed
    1. Rosman AS, Chaparala G, Monga A, Spungen AM, Bauman WA, Korsten MA. Intramuscular neostigmine and glycopyrrolate safely accelerated bowel evacuation in patients with spinal cord injury and defecatory disorders. Dig Dis Sci. 2008;53(10):2710–3. - PubMed
    1. Korsten MA, Spungen AM, Radulovic M, Rosman AS, Hunt K, Galea MD, et al. Neostigmine Administered With MoviPrep Improves Bowel Preparation for Elective Colonoscopy in Patients With Spinal Cord Injury: A Randomized Study. J Clin Gastroenterol. 2015;49(9):751–6. - PubMed

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