30 Participants NeededMy employer runs this trial

Bowel Program Interventions for Spinal Cord Injury

MN
Overseen ByMegan Narintarangkool
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Casa Colina Hospital and Centers for Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

ER

Emily Rosario, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Are You a Good Fit for This Trial?

This trial is for people admitted to an inpatient rehab unit with a spinal cord injury who have bowel problems that require regular use of suppositories and digital stimulation. Participants must need help managing their bowels due to nerve damage.

Inclusion Criteria

I have been admitted to an inpatient rehabilitation unit.
I have been diagnosed with a spinal cord injury.
I need a bowel program with suppositories and digital stimulation for my neurogenic bowel.

What Are the Treatments Tested in This Trial?

Interventions

  • Enemeez
  • Peristeen
  • Suppository

Trial Overview

The study compares three methods—suppository, mini enema (Enemeez), and transanal irrigation device (Peristeen)—to see which helps people with spinal cord injuries complete their bowel care faster and more effectively.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: SuppositoryActive Control1 Intervention
Group II: EnemeezActive Control1 Intervention
Group III: PeristeenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Casa Colina Hospital and Centers for Healthcare

Lead Sponsor

Trials
11
Recruited
350+