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

Overactive Bladder Syndrome Clinical Trial

— TaPaS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04256876
• Other study ID #: EC/2018/1267
• Status: Terminated
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• TTNS
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
See section 'arms'

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Gent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean voided volume per void	Difference in mean voided volume per void in percentage	12 weeks
Secondary	Maximum voided volume (ml)	Maximal voided volume per void ( ml) .	12 weeks
Secondary	Number of urgency incontinence episodes / 24 h.	Reduction in number of incontinence episodes per 24 hour	12 weeks
Secondary	Daytime voiding frequency	Mean voiding frequency per day	12 weeks
Secondary	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?	12 weeks
Secondary	Time to recurrence	Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks.	At 12 weeks of treatment + at 6 weeks of observational period without treatment.