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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2020-07-01

Brief Summary

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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.

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Detailed Description

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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

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized-controlled superiority trial:

TTNS(Active treatment) vs. Sham TTNS (placebo)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

TTNS

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

TTNS Sham

Intervention Type DEVICE

See section 'arms'

Interventions

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TTNS

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

Intervention Type DEVICE

TTNS Sham

See section 'arms'

Intervention Type DEVICE

Other Intervention Names

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Transcutaneous tibial nerve stimulation Sham therapy

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No