TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)
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- STATUS
- Recruiting
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- participants needed
- 24
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- sponsor
- University Hospital, Ghent
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.
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.
- 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.
Details
| Condition | Overactive Bladder Syndrome |
|---|---|
| Age | 5years - 12years |
| Treatment | TTNS, TTNS Sham |
| Clinical Study Identifier | NCT04256876 |
| Sponsor | University Hospital, Ghent |
| Last Modified on | 19 February 2024 |
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