Spinal Cord InjuryNCT07817199
Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury
A study testing Suppository, Enemeez and Peristeen in people with Spinal Cord Injury and Neurogenic Bowel, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Bowel
- What is being tested?
- Suppository, Enemeez and Peristeen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to acute rehab inpatient unit
- diagnosis of spinal cord injury
- reflexive type neurogenic bowel requiring bowel program with suppository and digital stimulation
Who cannot join
- anal or rectal stenosis
- active inflammatory bowel disease
- acute diverticulitis
- colorectal cancer
- ischemic colitis
- rectal surgery within the last 3 months
Show all 9Show fewer
- endoscopic polypectomy within the last 4 weeks
- areflexic bowel
- severe autonomic dysreflexia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767-1923
Emily Rosario, PhD, 909-596-7733 ext. 3036, erosario@casacolina.org
About this study
Official title: Time Comparison of Bisacodyl Suppository, Enemeez and Peristeen on Bowel Programs in Patients With Diagnosis of Spinal Cord Injury and Neurogenic Bowel
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.
Read more
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
Read the detailed description
The aim of the study is to guide clinical practice with the goal of reducing burden of care and improving patient experience with bowel program. The study specifically aims to determine the difference in time spent on bowel programs with either Suppository, Enemeez or Peristeen. This study aims to advance the process of bowel programs, which currently is a large time cost for our staff. By making bowel programs more efficient, we will allow our nursing staff to devote more time to other aspects of care while improving both patient and staff satisfaction. Ultimately, determining the most efficient bowel management for patients with diagnosis of spinal cord injury and neurogenic bowel will improve the continuum of care.
All patients admitted to inpatient rehab unit will be reviewed for diagnosis of spinal cord injury with reflexic neurogenic bowel. From this population we will exclude according to our exclusion criteria. Participants will then be recruited from these patients.
The primary goal of this study is to determine which intervention produces the most time effective bowel program: suppository, Enemeez or Peristeen. The study will consist of 3 cohorts of participants. 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.
Our secondary outcome is effectiveness of treatment which will be assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
The tertiary outcome of the study is to assess patient satisfaction and anticipated feasibility for home use. This will be assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research. Questionnaires will be distributed upon enrollment and after the intervention period, which may differ to discharge or several days prior to discharge depending on the bowel program chosen.
Following participation in treatment, patients will be transitioned to a bowel program that is accessible at home as prescribed by their physician.
- Conditions
- Spinal Cord Injury, Neurogenic Bowel
- Being tested
- Suppository, Enemeez, Peristeen
- Medical subject headings
- Spinal Cord Injuries, Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuppositoryDevice
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.
EnemeezDevice
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.
PeristeenDevice
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 group | Role | What they receive |
|---|---|---|
| Suppository | Active comparator | Bowel Program managed via Suppository (current standard of care at Casa Colina Hospital) Receives: Device: Suppository |
| Enemeez | Active comparator | Bowel Program via use of the Enemeez mini enema device Receives: Device: Enemeez |
| Peristeen | Active comparator | Bowel Program via the Peristeen Transanal Irrigation tool Receives: Device: Peristeen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every morning for approximately two hours, from enrollment and lasting 21 days
Secondary outcomes (1)
Effectiveness of treatment intervention
Assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
Measured: Assessed every morning via chart review from enrollment and lasting 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Rosario, PhD, Study director, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817199
- Sponsor's protocol ID
- BowelManagement
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34108835Wincentak 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.
PubMed 33529613House 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.
PubMed 9339153Dunn 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.
PubMed 7531868Christensen 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.
PubMed 16952543
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Comparison of Bisacodyl Suppository, Enemeez and Peristeen on Bowel Programs in Patients With Diagnosis of Spinal Cord Injury and Neurogenic Bowel
- ClinicalTrials.gov ID
- NCT07817199
- Acronym / sponsor ID
- BowelManagement
- Conditions
- Spinal Cord Injury, Neurogenic Bowel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The aim of the study is to guide clinical practice with the goal of reducing burden of care and improving patient experience with bowel program. The study specifically aims to determine the difference in time spent on bowel programs with either Suppository, Enemeez or Peristeen. This study aims to advance the process of bowel programs, which currently is a large time cost for our staff. By making bowel programs more efficient, we will allow our nursing staff to devote more time to other aspects of care while improving both patient and staff satisfaction. Ultimately, determining the most efficient bowel management for patients with diagnosis of spinal cord injury and neurogenic bowel will improve the continuum of care.
All patients admitted to inpatient rehab unit will be reviewed for diagnosis of spinal cord injury with reflexic neurogenic bowel. From this population we will exclude according to our exclusion criteria. Participants will then be recruited from these patients.
The primary goal of this study is to determine which intervention produces the most time effective bowel program: suppository, Enemeez or Peristeen. The study will consist of 3 cohorts of participants. 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.
Our secondary outcome is effectiveness of treatment which will be assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
The tertiary outcome of the study is to assess patient satisfaction and anticipated feasibility for home use. This will be assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research. Questionnaires will be distributed upon enrollment and after the intervention period, which may differ to discharge or several days prior to discharge depending on the bowel program chosen.
Following participation in treatment, patients will be transitioned to a bowel program that is accessible at home as prescribed by their physician.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suppository | Active comparator | Device: SuppositoryBowel Program managed via Suppository (current standard of care at Casa Colina Hospital) |
| Enemeez | Active comparator | Device: EnemeezBowel Program via use of the Enemeez mini enema device |
| Peristeen | Active comparator | Device: PeristeenBowel Program via the Peristeen Transanal Irrigation tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admission to acute rehab inpatient unit
- diagnosis of spinal cord injury
- reflexive type neurogenic bowel requiring bowel program with suppository and digital stimulation
Key exclusion criteria (9 listed)
- anal or rectal stenosis
- active inflammatory bowel disease
- acute diverticulitis
- colorectal cancer
- ischemic colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuppositoryThe 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. | Device | Suppository |
| EnemeezThe 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. | Device | Enemeez |
| PeristeenThe 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. | Device | Peristeen |
Primary outcome
Time required to complete bowel program
Time frame: Every morning for approximately two hours, from enrollment and lasting 21 days
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.
1 secondary outcome
Effectiveness of treatment intervention
Time frame: Assessed every morning via chart review from enrollment and lasting 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 34108835Johns 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.
- Background: PubMed 33529613Wincentak 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.
- Background: PubMed 9339153House 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.
- Background: PubMed 7531868Dunn 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.
- Background: PubMed 16952543Christensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Rosario, PhD study director
Casa Colina Hospital and Centers for Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suppository, Enemeez and Peristeen in people with Spinal Cord Injury and Neurogenic Bowel, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Narintarangkool ((909)596-7733 ext. 5233, mnarintarangkool@casacolina.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to complete bowel program (time frame: Every morning for approximately two hours, from enrollment and lasting 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07817199, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.