Clinical trial NCT04815226: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neurogenic Bladder
Neurogenic Bowel
Spina Bifida
Fecal Incontinence
Fecal Impaction
Urinary Incontinence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2021-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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:

  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

Primary outcomes:
measure: Change in nitrite and leukocyte esterase
timeFrame: Baseline
measure: Change in nitrite and leukocyte esterase
timeFrame: 4 weeks
measure: Change in nitrite and leukocyte esterase
timeFrame: 8 weeks
measure: Change in nitrite and leukocyte esterase
timeFrame: 12 weeks
Secondary outcomes:
measure: Seoul Fecal Scoring
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Korean Neurogenic Bowel Dysfunction Score
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Safety efficacy of Peristeen Transanal Irrigation
timeFrame: 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kwanjin Park, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: