NCT04256876

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

A Randomized-controlled Trial Comparing Transcutaneous Tibial Nerve Stimulation (TTNS) Versus Sham Therapy on Short Term Continence Outcomes in Children With the Idiopathic Overactive Bladder Syndrome: the TaPaS Trial Part I

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DEVICE	TTNS	See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
DEVICE	TTNS Sham	See section 'arms'

Timeline

• Start date: 2018-11-07
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2020-02-05
• Last updated: 2023-01-04

Locations

1 site across 1 country: Belgium