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

Seoul National University Hospital20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Peristeen Transanal IrrigationDEVICE

Using Peristeen Transanal Irrigation twice per week for 12 weeks

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change in nitrite and leukocyte esterase

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

Time frame: Baseline

Change in nitrite and leukocyte esterase

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

Time frame: 4 weeks

Change in nitrite and leukocyte esterase

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

Time frame: 8 weeks

Change in nitrite and leukocyte esterase

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

Time frame: 12 weeks

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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