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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04815226

Collaborator

Coloplast A/S (Industry)

Enrollment

Location

Arm

21.3

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Neurogenic Bowel Spina Bifida Fecal Incontinence Fecal Impaction Urinary Incontinence	Device: Peristeen Transanal Irrigation	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 14, 2021

Anticipated Primary Completion Date :

Jan 22, 2023

Anticipated Study Completion Date :

Jan 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 Using Peristeen Transanal Irrigation twice per week for 12 weeks

Arm

Intervention/Treatment

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

Using Peristeen Transanal Irrigation twice per week for 12 weeks

Outcome Measures

Primary Outcome Measures

Change in nitrite and leukocyte esterase [Baseline]
Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis
Change in nitrite and leukocyte esterase [4 weeks]
Either complete or partial reduction of nitrite and leukocyte esterase on the
Change in nitrite and leukocyte esterase [8 weeks]
Either complete or partial reduction of nitrite and leukocyte esterase on the
Change in nitrite and leukocyte esterase [12 weeks]
Either complete or partial reduction of nitrite and leukocyte esterase on the

Secondary Outcome Measures

Seoul Fecal Scoring [Baseline, 4 weeks, 8 weeks, 12 weeks]
Measuring the amount of feces in the abdomen using the images obtained from KUB (Kidney, Ureter, Bladder) x-ray.
Korean Neurogenic Bowel Dysfunction Score [Baseline, 4 weeks, 8 weeks, 12 weeks]
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
Safety efficacy of Peristeen Transanal Irrigation [4 weeks, 8 weeks, 12 weeks]
Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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: