Neurogenic BladderNCT04815226
The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection
A study testing Peristeen Transanal Irrigation in people with Neurogenic Bladder and Neurogenic Bowel, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Bladder, Neurogenic Bowel, Spina Bifida
- What is being tested?
- Peristeen Transanal Irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Apr 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages, 5 to 18, and are diagnosed with neurogenic bladder.
- Use CIC (CIC: Clean Intermittent Catheterization) daily to empty the bladder.
- A recent history of fecal incontinence within the last 3 months
- More than two episodes of urinary tract infection and/ or pyuria within the last 6 months
Who cannot join
- An anatomical abnormality of the bladder neck.
- Known intractable origin of bacteriuria such as urolithiasis (kidney stone) or nonfunctional renal segment.
- Received bladder augmentation surgery
- Patient without completion of toilet training
- Either received following treatment diagnosed according to Peristeen® product safety guideline:
- Anorectal malformation
Show all 13Show fewer
- Colorectal cancer
- Endoscopic polyp removal surgery in 3 months
- Ischemic colitis
- Acute inflammatory bowel disease
- Acute intestinal diverticulum.
- Radiotherapy to the colon
- Long-term corticosteroid usage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection in Patients With Neurogenic Bladder: a Prospective, Explorative Pilot Study
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.
Read the detailed description
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients diagnosed with neurogenic bladder. It is a prospective exploratory pilot study, and the participants will be asked to perform transanal irrigation twice weekly for 12 weeks (three months). At each visit, including baseline, the study endpoints will be assessed by basic urinalysis, KUB imaging, Seoul Fecal Scoring, and a survey (Korean Neurogenic Bowel Score).
- Conditions
- Neurogenic Bladder, Neurogenic Bowel, Spina Bifida, Fecal Incontinence, Fecal Impaction, Urinary Incontinence
- Being tested
- Peristeen Transanal Irrigation
- Medical subject headings
- Urinary Bladder, Neurogenic, Neurogenic Bowel, Spinal Dysraphism, Fecal Incontinence, Fecal Impaction, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peristeen Transanal IrrigationDevice
Using Peristeen Transanal Irrigation twice per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Using Peristeen Transanal Irrigation | Other | All participants in the trial will use Peristeen Transanal Irrigation. Eligible volunteers will be those patients who have failed conventional supportive bowel care, have neurogenic bladder, and use CIC (ClC: Clean Intermittent Catheterization) daily. Receives: Device: Peristeen Transanal Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nitrite and leukocyte esterase
Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis
Measured: Baseline
Change in nitrite and leukocyte esterase
Either complete or partial reduction of nitrite and leukocyte esterase on the
Measured: 4 weeks
Change in nitrite and leukocyte esterase
Either complete or partial reduction of nitrite and leukocyte esterase on the
Measured: 8 weeks
Change in nitrite and leukocyte esterase
Either complete or partial reduction of nitrite and leukocyte esterase on the
Measured: 12 weeks
Secondary outcomes (3)
Seoul Fecal Scoring
Measuring the amount of feces in the abdomen using the images obtained from KUB (Kidney, Ureter, Bladder) x-ray.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Korean Neurogenic Bowel Dysfunction Score
Quality of life and bowel symptom changes after using Peristeen Transanal Irrigation. 0 being having excellent quality of life and least bowel symptom changes, and 47 being the highest with extremely low QoL
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Safety efficacy of Peristeen Transanal Irrigation
Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start14 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Responsible party
- Principal investigator, Kwanjin Park, Seoul National University Hospital
- Investigators
- Kwanjin Park, M.D. Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815226
- Sponsor's protocol ID
- 2102-095-1198
- Status last verified
- May 2023
- First submitted
- 16 Mar 2021
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection in Patients With Neurogenic Bladder: a Prospective, Explorative Pilot Study
- ClinicalTrials.gov ID
- NCT04815226
- Acronym / sponsor ID
- 2102-095-1198
- Conditions
- Neurogenic Bladder, Neurogenic Bowel, Spina Bifida, Fecal Incontinence, Fecal Impaction, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Mar 2021 (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.
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.
Detailed description
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients diagnosed with neurogenic bladder. It is a prospective exploratory pilot study, and the participants will be asked to perform transanal irrigation twice weekly for 12 weeks (three months). At each visit, including baseline, the study endpoints will be assessed by basic urinalysis, KUB imaging, Seoul Fecal Scoring, and a survey (Korean Neurogenic Bowel Score).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using Peristeen Transanal Irrigation | Other | Device: Peristeen Transanal IrrigationAll participants in the trial will use Peristeen Transanal Irrigation. Eligible volunteers will be those patients who have failed conventional supportive bowel care, have neurogenic bladder, and use CIC (ClC: Clean Intermittent Catheterization) daily. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between the ages, 5 to 18, and are diagnosed with neurogenic bladder.
- Use CIC (CIC: Clean Intermittent Catheterization) daily to empty the bladder.
- A recent history of fecal incontinence within the last 3 months
- More than two episodes of urinary tract infection and/ or pyuria within the last 6 months
Key exclusion criteria (13 listed)
- An anatomical abnormality of the bladder neck.
- Known intractable origin of bacteriuria such as urolithiasis (kidney stone) or nonfunctional renal segment.
- Received bladder augmentation surgery
- Patient without completion of toilet training
- Either received following treatment diagnosed according to Peristeen® product safety guideline:
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 |
|---|---|---|
| Peristeen Transanal IrrigationUsing Peristeen Transanal Irrigation twice per week for 12 weeks | Device | Using Peristeen Transanal Irrigation |
Primary outcome
Change in nitrite and leukocyte esterase
Time frame: Baseline
Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis
Change in nitrite and leukocyte esterase
Time frame: 4 weeks
Either complete or partial reduction of nitrite and leukocyte esterase on the
Change in nitrite and leukocyte esterase
Time frame: 8 weeks
Either complete or partial reduction of nitrite and leukocyte esterase on the
Change in nitrite and leukocyte esterase
Time frame: 12 weeks
Either complete or partial reduction of nitrite and leukocyte esterase on the
3 secondary outcomes
Seoul Fecal Scoring
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Korean Neurogenic Bowel Dysfunction Score
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Safety efficacy of Peristeen Transanal Irrigation
Time frame: 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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. This study is not recruiting at the moment.
Kwanjin Park, M.D. Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peristeen Transanal Irrigation in people with Neurogenic Bladder and Neurogenic Bowel, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nitrite and leukocyte esterase (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.