Fecal Impaction, Fecal Incontinence, Neurogenic Bladder, Neurogenic Bowel, Spina Bifida, Urinary Incontinence
Conditions
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).
Interventions
DEVICEPeristeen Transanal Irrigation
Using Peristeen Transanal Irrigation twice per week for 12 weeks
Sponsors
Coloplast A/S
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nitrite and leukocyte esterase | Baseline | Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seoul Fecal Scoring | 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. |
| Korean Neurogenic Bowel Dysfunction Score | 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 |
| Safety efficacy of Peristeen Transanal Irrigation | 4 weeks, 8 weeks, 12 weeks | Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire |
Countries
South Korea
Outcome results
None listed