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

Study Overview
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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.

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).

Official Title
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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

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

Intervention / Treatment
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* Device: Peristeen Transanal Irrigation


Participation Criteria
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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: Anorectal malformation 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Using Peristeen Transanal Irrigation<br>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<br>* Using Peristeen Transanal Irrigation twice per week for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis | Baseline | 
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the | 4 weeks | 
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the | 8 weeks | 
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seoul Fecal Scoring | Measuring the amount of feces in the abdomen using the images obtained from KUB (Kidney, Ureter, Bladder) x-ray. | 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 | 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 | 4 weeks, 8 weeks, 12 weeks |