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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Urinary Incontinence; Neurogenic Bowel; Fecal Incontinence; Neurogenic Bladder; Spina Bifida; Fecal Impaction
• Intervention / Treatment: Device: Peristeen Transanal Irrigation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Infections; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Congenital Abnormalities; Gastrointestinal Diseases; Urination Disorders; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nervous System Malformations; Intestinal Obstruction; Neural Tube Defects; Urinary Incontinence; Urinary Tract Infections; Urinary Bladder, Neurogenic; Neurogenic Bowel; Fecal Incontinence; Spinal Dysraphism; Fecal Impaction
• Other Study ID Numbers: 2102-095-1198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No