Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury

NCT07817199 | Not Yet Recruiting

• 1 other identifier: BowelManagement
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are:

• Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs?
• Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation?
• Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided. Participants in this study will:
• Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital
• Will receive the same tool for their bowel program for the majority or entirety of their stay
• Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed
• Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home

Conditions

Neurogenic Bowel; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Time required to complete bowel program

  During the bowel program nursing staff will document time suppository or Enemeez is given. In the case of Pertisteen, the nurse will document the time out of bed instead. This will be done manually via a paper chart that is placed in the patient's room. The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours.

  Every morning for approximately two hours, from enrollment and lasting 21 days

Secondary Outcomes (1)

• Effectiveness of treatment intervention

  Assessed every morning via chart review from enrollment and lasting 21 days

Other Outcomes (1)

• Patient satisfaction and anticipated feasibility for home use

  Upon enrollment and again at 3 weeks

Study Arms (3)

Suppository

ACTIVE COMPARATOR

Bowel Program managed via Suppository (current standard of care at Casa Colina Hospital)

Device: Suppository

Enemeez

ACTIVE COMPARATOR

Bowel Program via use of the Enemeez mini enema device

Device: Enemeez

Peristeen

ACTIVE COMPARATOR

Bowel Program via the Peristeen Transanal Irrigation tool

Device: Peristeen

Interventions

Suppository DEVICE

The patient will receive a suppository 15-20 minutes prior to being transferred to toilet. Then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.

Suppository

Enemeez DEVICE

The patient will receive the 5mL enema then be transferred onto the toilet. If no evacuation occurs within 15 minutes, then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.

Enemeez

Peristeen DEVICE

The Peristeen device will be prepared prior to sitting the participant on the toilet. The lubricated rectal catheter will be inserted, and the retention balloon will be gently inflated to ensure a rectal seal. The irrigation pump will then pump water into the rectum. The balloon will be deflated and the catheter removed to allow for emptying of the water and stool. The catheter will be discarded.

Peristeen

Eligibility Criteria

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

You may qualify if:

• admission to acute rehab inpatient unit
• diagnosis of spinal cord injury
• reflexive type neurogenic bowel requiring bowel program with suppository and digital stimulation

You may not qualify if:

• anal or rectal stenosis
• active inflammatory bowel disease
• acute diverticulitis
• colorectal cancer
• ischemic colitis
• rectal surgery within the last 3 months
• endoscopic polypectomy within the last 4 weeks
• areflexic bowel
• severe autonomic dysreflexia

Sponsors & Collaborators

• Casa Colina Hospital and Centers for Healthcare: lead

Related Publications (5)

• Wincentak J, Xu Y, Rudden L, Kassam-Lallani D, Mullin A, Truong C, Krog K, Kingsnorth S. Current State of Knowledge on Digital Rectal Stimulation in Individuals With Traumatic and Nontraumatic Spinal Cord Injury: A Scoping Review. Arch Phys Med Rehabil. 2021 Sep;102(9):1816-1825. doi: 10.1016/j.apmr.2020.12.023. Epub 2021 Jan 30.

  PMID: 33529613 BACKGROUND

• Johns J, Krogh K, Rodriguez GM, Eng J, Haller E, Heinen M, Laredo R, Longo W, Montero-Colon W, Wilson C, Korsten M. Management of Neurogenic Bowel Dysfunction in Adults after Spinal Cord Injury: Clinical Practice Guideline for Health Care Providers. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):75-151. doi: 10.46292/sci2702-75. Epub 2021 May 24. No abstract available.

  PMID: 34108835 BACKGROUND

• House JG, Stiens SA. Pharmacologically initiated defecation for persons with spinal cord injury: effectiveness of three agents. Arch Phys Med Rehabil. 1997 Oct;78(10):1062-5. doi: 10.1016/s0003-9993(97)90128-3.

  PMID: 9339153 BACKGROUND

• Dunn KL, Galka ML. A comparison of the effectiveness of Therevac SB and bisacodyl suppositories in SCI patients' bowel programs. Rehabil Nurs. 1994 Nov-Dec;19(6):334-8. doi: 10.1002/j.2048-7940.1994.tb01336.x.

  PMID: 7531868 BACKGROUND

• Christensen P, Bazzocchi G, Coggrave M, Abel R, Hultling C, Krogh K, Media S, Laurberg S. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006 Sep;131(3):738-47. doi: 10.1053/j.gastro.2006.06.004.

  PMID: 16952543 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel

Interventions

Pessaries

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)

Surgical Equipment; Equipment and Supplies

Study Officials

• Emily Rosario, PhD

  Casa Colina Hospital and Centers for Healthcare

  STUDY DIRECTOR

Central Study Contacts

Megan Narintarangkool

CONTACT

(909)596-7733; mnarintarangkool@casacolina.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be placed in a cohort based on the date of bowel program initiation. Each month will be assigned a different intervention type, and all participants with bowel program initiated during that month will be using the assigned intervention. During the bowel program nursing staff will document time suppository or Enemeez is given. In the case of Pertisteen, the nurse will document the time out of bed instead. The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours. If a participant is on a program at the time of cohort transition, that participant will remain on their established program.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 14, 2026
• Study Start: September 4, 2026
• Primary Completion (Estimated): July 4, 2027
• Study Completion (Estimated): August 4, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share