TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I) (TaPaS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04256876|
Recruitment Status : Terminated (due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.)
First Posted : February 5, 2020
Last Update Posted : January 4, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Device: TTNS Device: TTNS Sham||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Prospective randomized-controlled superiority trial:
TTNS(Active treatment) vs. Sham TTNS (placebo)
|Masking:||Double (Participant, Outcomes Assessor)|
Participants are blinded for the given treatment ( Active TTNS vs. Sham TTNS) by the care provider ( Physiotherapist).
The outcomes assessor (the pediatric urologist) isn't aware of the treatment neither.
|Official Title:||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|
|Actual Study Start Date :||November 7, 2018|
|Actual Primary Completion Date :||July 1, 2020|
|Actual Study Completion Date :||July 1, 2020|
Active Comparator: Active TTNS
Children treated by transcutaneous tibial nerve stimulation. TENS device connected to adhesive electrodes. Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
Other Name: Transcutaneous tibial nerve stimulation
Sham Comparator: TTNS sham intervention
Children treated by TTNS with same positioning as the active TTNS treatment. Stimulation settings: 200 µS, 20 Hz, 0-1 V. Patients and parents will be told that electric currence is given, but that no sensation will be feld.
Home therapy: Daily stimulation during 60 minutes.
Device: TTNS Sham
See section 'arms'
Other Name: Sham therapy
- Mean voided volume per void [ Time Frame: 12 weeks ]Difference in mean voided volume per void in percentage
- Maximum voided volume (ml) [ Time Frame: 12 weeks ]Maximal voided volume per void ( ml) .
- Number of urgency incontinence episodes / 24 h. [ Time Frame: 12 weeks ]Reduction in number of incontinence episodes per 24 hour
- Daytime voiding frequency [ Time Frame: 12 weeks ]Mean voiding frequency per day
- Satisfaction on urinary symptoms reported by parents [ Time Frame: 12 weeks ]Subjective satisfaction reported by the parents - on a 7 point likert scale- "How satisfied of dissatisfied would you be if the bladder symptoms of your child would persist like this?
- Time to recurrence [ Time Frame: At 12 weeks of treatment + at 6 weeks of observational period without treatment. ]Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256876
|University Hospital Ghent|
|Gent, East-Flanders, Belgium, 9000|
|Principal Investigator:||Anne-Françoise Spinoit, Professor||University Hospital, Ghent|