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

Primary Purpose

Neurogenic Bladder, Neurogenic Bowel, Spina Bifida

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Peristeen Transanal Irrigation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bladder

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Using Peristeen Transanal Irrigation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Seoul Fecal Scoring
Measuring the amount of feces in the abdomen using the images obtained from KUB (Kidney, Ureter, Bladder) x-ray.
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
Safety efficacy of Peristeen Transanal Irrigation
Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire

Full Information

First Posted
March 16, 2021
Last Updated
May 3, 2023
Sponsor
Seoul National University Hospital
Collaborators
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04815226
Brief Title
The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Neurogenic Bowel, Spina Bifida, Fecal Incontinence, Fecal Impaction, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Using Peristeen Transanal Irrigation
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Peristeen Transanal Irrigation
Intervention Description
Using Peristeen Transanal Irrigation twice per week for 12 weeks
Primary Outcome Measure Information:
Title
Change in nitrite and leukocyte esterase
Description
Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis
Time Frame
Baseline
Title
Change in nitrite and leukocyte esterase
Description
Either complete or partial reduction of nitrite and leukocyte esterase on the
Time Frame
4 weeks
Title
Change in nitrite and leukocyte esterase
Description
Either complete or partial reduction of nitrite and leukocyte esterase on the
Time Frame
8 weeks
Title
Change in nitrite and leukocyte esterase
Description
Either complete or partial reduction of nitrite and leukocyte esterase on the
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Seoul Fecal Scoring
Description
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
Title
Korean Neurogenic Bowel Dysfunction Score
Description
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
Title
Safety efficacy of Peristeen Transanal Irrigation
Description
Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire
Time Frame
4 weeks, 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwanjin Park, M.D. Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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