Recruiting

Bowel Program Tools

Sponsor:

Casa Colina Hospital and Centers for Healthcare

Code:

NCT07817199

Conditions

Spinal Cord Injury

Neurogenic Bowel

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Suppository

Enemeez

Peristeen

Study Details

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

Spinal Cord Injury

Neurogenic Bowel

Study ID

NCT07817199

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Suppository

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

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

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.

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 and Locations

Central contacts

Megan Narintarangkool

(909)596-7733mnarintarangkool@casacolina.org

Locations

Casa Colina Hospital and Centers for Healthcare

Recruiting

Pomona, California, United States, 91767-1923

Contacts

Emily Rosario, PhD

909-596-7733erosario@casacolina.org

More Information

Sponsor

Casa Colina Hospital and Centers for Healthcare

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Casa Colina Hospital and Centers for Healthcare on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.