Overactive Bladder Syndrome (OAB) Overactive bladder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 6 to 16 years with a diagnosed OABWillingness to complete the entire follow-up period
Exclusion criteria
Exclusion criteria: Neurological conditionsCongenital urinary tract abnormalitiesPrevious neuromodulation within the past 3 monthsPrevious medication treatment within the past 2 weeksActive pelvic floor physiotherapy treatmentPost void residu > 35% of voided volumeMore than 2 proven UTI’s in the last 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the change in voiding frequency, as documented in a two-day voiding diary, before and after six weeks of peroneal eTNM, and after 12 weeks of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| One of the secondary objectives is to evaluate the change in voiding frequency, as recorded in a two-day voiding diary, after the 12-week follow-up period in comparison to baseline and post-intervention (week 6). The other secondary objectives are to evaluate treatment-related side effects and patient satisfaction, Vancouver Symptom Score for Dysfunctional Elimination Syndrome (VSSDES scores), changes in Pediatric Urinary Incontinence Quality of Life (PinQ) scores, Bristol Stool Chart (BSC) and alterations in the frequency of urgency episodes, urinary incontinence episodes, and nocturnal incontinence. | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam