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

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

Recruiting
5-12 years
All
Phase N/A

Overview

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.

Description

Non invasive neuromodulation therapy for children with the overactive bladder syndrome is a highly under investigated topic in medical literature.

Only 2 studies ( Patidar et al. and Boudaouid et al.) investigated the use of tibial nerve stimulation with adhesive electrodes.

  1. In the first trial the superiority of TTNS vs.Sham therapy for the therapeutic management of children with OAB naive to any pharmacological treatment will be examined.

Clinical outcomes will be assessed by the use of daytime and nighttime bladder diaries.

Assessment of outcomes at baseline, after 6 weeks and 12 weeks of treatment, and investigation of mean time to partial or complete relapse following 6 weeks observation.

After a wash-out period of 6 weeks, patients from the part I Sham group will be able to be included for TaPaS part II.

Eligibility

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.

Study details
    Overactive Bladder Syndrome

NCT04256876

University Hospital, Ghent

16 February 2024

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