Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury

Part of paid clinical trials in Pomona, California.

Sponsor
Casa Colina Hospital and Centers for Healthcare
Study ID
NCT07817199
Status
Recruiting
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Conditions

  • Neurogenic Bowel
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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

Key Dates

First listed
Sep 14, 2026
Start date
Oct 1, 2026
Status verified
Oct 2026
Primary completion
Jul 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Suppository
    Bowel Program managed via Suppository (current standard of care at Casa Colina Hospital)
  • Active Comparator: Enemeez
    Bowel Program via use of the Enemeez mini enema device
  • Active Comparator: Peristeen
    Bowel Program via the Peristeen Transanal Irrigation tool

Primary Outcome Measure

Time required to complete bowel program [ Time Frame: Every morning for approximately two hours, from enrollment and lasting 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Casa Colina Hospital and Centers for HealthcarePomonaCalifornia91767-1923
Emily Rosario, PhD
[email protected]
909-596-7733

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By research site
Casa Colina Hospital and Centers for Healthcare· Pomona, CA

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