NCT04256876: TaPaS

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

Terminated NA Last updated 4 January 2023

What this trial tests

NA trial testing TTNS in Overactive Bladder Syndrome in 6 participants. Terminated before completion.

Timeline

7 November 2018

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	7 November 2018
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across Belgium

Drugs / interventions tested

• TTNS
• TTNS Sham

Conditions studied

• Overactive Bladder Syndrome — all drugs for Overactive Bladder Syndrome →

Sponsor

University Hospital, Ghent

Who can join

Adults 5 to 12, any sex, with Overactive Bladder Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofol
   Ghijselings L, Renson C, Van de Walle J, Everaert K, et al · · 2021 · cited 5× · PMID 33810804 · DOI 10.1186/s13063-021-05117-8
2. Clinical efficacy of Transcutaneous Tibial Nerve Stimulation (TTNS) versus Sham therapy (Part I) and TTNS versus Percutaneous Tibial Nerve Stimulation (PTNS) (Part II) on the short term in children with the idiopathic overactive bladder syndrome: Protocol for Part I of the two-fo
   Ghijselings L, Renson C, Walle JV, Everaert K, et al · · 2021 · DOI 10.21203/rs.3.rs-35470/v2