Status:
UNKNOWN
The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Coloplast A/S
Conditions:
Neurogenic Bladder
Neurogenic Bowel
Eligibility:
All Genders
5-18 years
Phase:
NA
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 explor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04815226
Start Date
April 14 2021
End Date
December 31 2023
Last Update
May 6 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea