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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2023-12-31

Brief Summary

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This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Peristeen Transanal Irrigation

Intervention Type DEVICE

Using Peristeen Transanal Irrigation twice per week for 12 weeks

Interventions

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Peristeen Transanal Irrigation

Using Peristeen Transanal Irrigation twice per week for 12 weeks

Intervention Type DEVICE

Eligibility Criteria

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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

* 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 corticosteroid usage

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes