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

Not Applicable

• Conditions: Neurogenic Bowel; Spina Bifida; Fecal Incontinence; Fecal Impaction; Urinary Incontinence; Neurogenic Bladder
• Interventions: Device: Peristeen Transanal Irrigation

• Registration Number: NCT04815226
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-24
• Study Start: 2021-04-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Using Peristeen Transanal Irrigation	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.

Primary Outcome Measures

Name	Time	Method
Change in nitrite and leukocyte esterase	12 weeks	Either complete or partial reduction of nitrite and leukocyte esterase on the

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of