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

University Hospital, Ghent6 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Overactive Bladder Syndrome

Interventions

TTNSDEVICE

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

TTNS ShamDEVICE

See section 'arms'

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Ghent

Ghent, East-Flanders, Belgium

Outcomes

Primary Outcomes

Mean voided volume per void

Difference in mean voided volume per void in percentage

Time frame: 12 weeks

Secondary Outcomes

Maximum voided volume (ml)

Maximal voided volume per void ( ml) .

Time frame: 12 weeks

Number of urgency incontinence episodes / 24 h.

Reduction in number of incontinence episodes per 24 hour

Time frame: 12 weeks

Daytime voiding frequency

Mean voiding frequency per day

Time frame: 12 weeks

Satisfaction on urinary symptoms reported by parents

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 frame: 12 weeks

Time to recurrence

Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks.

Time frame: At 12 weeks of treatment + at 6 weeks of observational period without treatment.

Data from ClinicalTrials.gov

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