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

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Overactive Bladder Syndrome

Treatments: Device: TTNS Sham; Device: TTNS

Study type: Interventional

Funder types: Other

Identifiers

NCT04256876

EC/2018/1267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

6 participants in 2 patient groups

Active TTNS

Active Comparator group

Description:

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.

Treatment:

Device: TTNS

TTNS sham intervention

Sham Comparator group

Description:

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.

Treatment:

Device: TTNS Sham