NCT04256876

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

January 15, 2020

Last Update Submit

January 2, 2023

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mean voided volume per void

    Difference in mean voided volume per void in percentage

    12 weeks

Secondary Outcomes (5)

  • Maximum voided volume (ml)

    12 weeks

  • Number of urgency incontinence episodes / 24 h.

    12 weeks

  • Daytime voiding frequency

    12 weeks

  • Satisfaction on urinary symptoms reported by parents

    12 weeks

  • Time to recurrence

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

Study Arms (2)

Active TTNS

ACTIVE COMPARATOR

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.

Device: TTNS

TTNS sham intervention

SHAM COMPARATOR

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.

Device: TTNS Sham

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.

Also known as: Transcutaneous tibial nerve stimulation
Active TTNS
TTNS ShamDEVICE

See section 'arms'

Also known as: Sham therapy
TTNS sham intervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 25979217BACKGROUND

  • 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.

    PMID: 26279104RESULT

  • 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.

    PMID: 33810804DERIVED

Study Officials

  • Anne-Françoise Spinoit, Professor

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized-controlled superiority trial: TTNS(Active treatment) vs. Sham TTNS (placebo)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

February 5, 2020

Study Start

November 7, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)