Use of Prokinetics During Inpatient Bowel Care for SCI Patients

NCT02370433 | Unknown Phase 1

• 1 other identifier: KOR-12-035
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Neurogenic Bowel

Keywords

Spinal Cord Injury; Neurogenic Bowel; Bowel Evacuation

Outcome Measures

Primary Outcomes (1)

• 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)

  We aim to evaluate the effect of treatment with NG through Iontophoresis during routine bowel care (BC) during inpatient visits. Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed

  24months

Secondary Outcomes (2)

• Effect of Medication on Impaction (changes in fecal impaction and constipation by documenting weekly weight and pre to post treatment plain abdominal x-ray)

  24months

• Subjective Feedback from Inpatients (Treatment Satisfaction Questionnaire for Medication (TSQM)

  24months

Study Arms (3)

Bowel Evacuation via IV

EXPERIMENTAL

The study design will consist of an intravenous (IV) screening visit to determine each individual's response to neostigmine and glycopyrrolate (NG).

Drug: Intravenous Neostigmine and Glycopyrrolate

Bowel Evacuation Titration

EXPERIMENTAL

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.

Drug: Transdermal Neostigmine and Glycopyrrolate

Bowel Evacuation Iontophoresis

EXPERIMENTAL

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.

Drug: Transdermal Neostigmine and Glycopyrrolate

Interventions

Intravenous Neostigmine and Glycopyrrolate DRUG

Bowel Evacuation via IV

Transdermal Neostigmine and Glycopyrrolate DRUG

Bowel Evacuation Iontophoresis; Bowel Evacuation Titration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years
• Spinal Cord Injury (SCI):
• greater than 1 year duration
• excess time for bowel evacuation (\> 60minutes per session)

You may not qualify if:

• 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 and/or Bladder
• Myocardial Infarction in the past 6months
• Blood Pressure ≥160/100 mmHg with/without being on 3 or more different classes of antihypertensive medications
• Organ Damage (heart \& kidney) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) as a result of hypertension
• Known past history of coronary artery disease, chronic heart failure, bradyarrythmia
• Slow Heart Rate (\<45bpm)
• Active respiratory diseases
• Known history of asthma during lifetime
• Recent (within 3months) respiratory infections
• Adrenal Insufficiency
• Pregnancy or potential for pregnancy
• Lactating/nursing females

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mark A Korsten, MD

CONTACT

718-584-9000; mark.korsten@va.gov

Tradd Cummings, MS

CONTACT

718-584-9000; tradd.cummings@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroneterology

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: December 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

US (1)