TerminatedNot Applicable

TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)

Stopped: due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.

Belgium6 participantsStarted 2018-11-07

Plain-language summary

Part I of the TaPaS trial forms part of a twofold clinical RCT: Part 1) A prospective RCT comparing the efficacy of transcutaneous tibial nerve stimulation (TTNS) with TTNS sham therapy for children with idiopathic overactive bladder on clinical and patient reported outcomes (PROMS). Part 2) A prospective RCT comparing TTNS versus Percutaneous tibial nerve stimulation (PTNS) on clinical outcomes and PROMS.

Who can participate

Age range5 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children between 5 and 12 years old, clinically diagnosed with the idiopathic overactive bladder syndrome with urinary incontinence (daytime and/or nighttime) * Untreated, except from urotherapy. Exclusion Criteria: * Enuresis nocturna due to nocturnal polyuria * Dysfunctional voiding * Neurogenic bladder * Psychiatric disorders, behavioural disturbances or mental disabilities * Treated before with pharmacotherapy or invasive therapies for OAB * Children with parents unable to record reliably micturition diaries.

What they're measuring

Mean voided volume per void

Timeframe: 12 weeks

Trial details

NCT IDNCT04256876

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Overactive Bladder Syndrome trials