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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

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.

Study details
    Overactive Bladder Syndrome

NCT04256876

University Hospital, Ghent

19 February 2024

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