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Enrolling by invitationNCT04815226Updated May 6, 2023

The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection

An interventional study of Peristeen Transanal Irrigation in Neurogenic Bladder, Neurogenic Bowel and Spina Bifida, sponsored by Seoul National University Hospital. Enrolling by invitation at 1 site in Korea, Republic of. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
5 Years to 18 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Neurogenic Bladder
  • Neurogenic Bowel
  • Spina Bifida
  • Fecal Incontinence
  • Fecal Impaction
  • Urinary Incontinence
03

In context

Urinary Bladder, Neurogenic

189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

This study's planned enrollment of 20 is below the median of 39 across 125 interventional studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Anorectal malformation
    2. Colorectal cancer
    3. Endoscopic polyp removal surgery in 3 months
    4. Ischemic colitis
    5. Acute inflammatory bowel disease
    6. Acute intestinal diverticulum.
    7. Radiotherapy to the colon
    8. Long-term usage
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Using Peristeen Transanal Irrigation

    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.

    Device: Peristeen Transanal Irrigation

Interventions

  • DevicePeristeen Transanal Irrigation

    Using Peristeen Transanal Irrigation twice per week for 12 weeks

06

What researchers measure

Primary outcomes

  1. Change in nitrite and leukocyte esterase

    Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis

    Time frame: Baseline

  2. Change in nitrite and leukocyte esterase

    Either complete or partial reduction of nitrite and leukocyte esterase on the

    Time frame: 4 weeks

  3. Change in nitrite and leukocyte esterase

    Either complete or partial reduction of nitrite and leukocyte esterase on the

    Time frame: 8 weeks

  4. Change in nitrite and leukocyte esterase

    Either complete or partial reduction of nitrite and leukocyte esterase on the

    Time frame: 12 weeks

Secondary outcomes

  1. Seoul Fecal Scoring

    Measuring the amount of feces in the abdomen using the images obtained from KUB (Kidney, Ureter, Bladder) x-ray.

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  2. 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

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

  3. Safety efficacy of Peristeen Transanal Irrigation

    Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire

    Time frame: 4 weeks, 8 weeks, 12 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2021 (actual). Primary completion is estimated for Dec 2023, 32 months after the start.

Of 47 non-industry interventional studies with no phase under Urinary Bladder, Neurogenic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 32 months is below that.

Counting every sponsor, half of 51 studies reached it within 33 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2021
First posted
Mar 24, 2021
StartActual
Apr 14, 2021
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
May 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04815226
Lead sponsor
Seoul National University Hospital
Collaborators
Coloplast A/S
Responsible party
Kwanjin Park (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 24, 2021
Start date
Apr 14, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 6, 2023

Study contacts

Kwanjin Park, M.D. Ph.D
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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