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

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ClinicalTrials.gov Identifier: NCT04815226
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Coloplast A/S
Information provided by (Responsible Party):
Kwanjin Park, 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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Neurogenic Bowel Spina Bifida Fecal Incontinence Fecal Impaction Urinary Incontinence Device: Peristeen Transanal Irrigation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 14, 2021
Estimated Primary Completion Date : January 22, 2022
Estimated Study Completion Date : January 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in nitrite and leukocyte esterase [ Time Frame: Baseline ]
    Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis

  2. Change in nitrite and leukocyte esterase [ Time Frame: 4 weeks ]
    Either complete or partial reduction of nitrite and leukocyte esterase on the

  3. Change in nitrite and leukocyte esterase [ Time Frame: 8 weeks ]
    Either complete or partial reduction of nitrite and leukocyte esterase on the

  4. Change in nitrite and leukocyte esterase [ Time Frame: 12 weeks ]
    Either complete or partial reduction of nitrite and leukocyte esterase on the


Secondary Outcome Measures :
  1. Seoul Fecal Scoring [ Time Frame: 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.

  2. Korean Neurogenic Bowel Dysfunction Score [ Time Frame: 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

  3. Safety efficacy of Peristeen Transanal Irrigation [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
    Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815226


Contacts
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Contact: Kwanjin Park, M.D. Ph.D +82-2-2072-0695 urodori@naver.com
Contact: Louis Kim, B.S. +82-10-4201-0636 kim.hyunkyu11@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Louis Kim, B.S.    +82-10-4201-0636    kim.hyunkyu11@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Coloplast A/S
Investigators
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Principal Investigator: Kwanjin Park, M.D. Ph.D Seoul National University Hospital
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Responsible Party: Kwanjin Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04815226    
Other Study ID Numbers: 2102-095-1198
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Fecal Incontinence
Neurogenic Bowel
Fecal Impaction
Urinary Bladder, Neurogenic
Spinal Dysraphism
Urinary Incontinence
Infection
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Colonic Diseases, Functional
Colonic Diseases
Intestinal Obstruction