Clinical trial NCT04256876: TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder Syndrome
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized-controlled superiority trial:

TTNS(Active treatment) vs. Sham TTNS (placebo)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Children between 5 and 12 years old, clinically diagnosed with the idiopathic overactive bladder syndrome with urinary incontinence (daytime and/or nighttime)
* Untreated, except from urotherapy.

Exclusion Criteria:

* Enuresis nocturna due to nocturnal polyuria
* Dysfunctional voiding
* Neurogenic bladder
* Psychiatric disorders, behavioural disturbances or mental disabilities
* Treated before with pharmacotherapy or invasive therapies for OAB
* Children with parents unable to record reliably micturition diaries.

Primary outcomes:
measure: Mean voided volume per void
timeFrame: 12 weeks
Secondary outcomes:
measure: Maximum voided volume (ml)
timeFrame: 12 weeks
measure: Number of urgency incontinence episodes / 24 h.
timeFrame: 12 weeks
measure: Daytime voiding frequency
timeFrame: 12 weeks
measure: Satisfaction on urinary symptoms reported by parents
timeFrame: 12 weeks
measure: Time to recurrence
timeFrame: At 12 weeks of treatment + at 6 weeks of observational period without treatment.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Anne-Françoise Spinoit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boudaoud N, Binet A, Line A, Chaouadi D, Jolly C, Fiquet CF, Ripert T, Merol ML. Management of refractory overactive bladder in children by transcutaneous posterior tibial nerve stimulation: A controlled study. J Pediatr Urol. 2015 Jun;11(3):138.e1-10. doi: 10.1016/j.jpurol.2014.09.013. Epub 2015 Mar 31.
citation: Patidar N, Mittal V, Kumar M, Sureka SK, Arora S, Ansari MS. Transcutaneous posterior tibial nerve stimulation in pediatric overactive bladder: A preliminary report. J Pediatr Urol. 2015 Dec;11(6):351.e1-6. doi: 10.1016/j.jpurol.2015.04.040. Epub 2015 Jul 29.
citation: Ghijselings L, Renson C, Van de Walle J, Everaert K, Spinoit AF. 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 twofold double-blinded randomized controlled TaPaS trial. Trials. 2021 Apr 2;22(1):247. doi: 10.1186/s13063-021-05117-8.