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

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ClinicalTrials.gov Identifier: NCT04256876
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Urologie, University Hospital, Ghent

Study Description
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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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Device: TTNS Device: TTNS Sham Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective randomized-controlled superiority trial:

TTNS(Active treatment) vs. Sham TTNS (placebo)
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.
Primary Purpose: Treatment
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
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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.
Other Name: Transcutaneous tibial nerve stimulation
Sham Comparator: 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.

 Device: TTNS Sham
See section 'arms'
Other Name: Sham therapy


Outcome Measures
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Primary Outcome Measures :
  1. Mean voided volume per void [ Time Frame: 12 weeks ]
    Difference in mean voided volume per void in percentage


Secondary Outcome Measures :
  1. Maximum voided volume (ml) [ Time Frame: 12 weeks ]
    Maximal voided volume per void ( ml) .

  2. Number of urgency incontinence episodes / 24 h. [ Time Frame: 12 weeks ]
    Reduction in number of incontinence episodes per 24 hour

  3. Daytime voiding frequency [ Time Frame: 12 weeks ]
    Mean voiding frequency per day

  4. Satisfaction on urinary symptoms reported by parents [ Time Frame: 12 weeks ]
    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?

  5. Time to recurrence [ Time Frame: At 12 weeks of treatment + at 6 weeks of observational period without treatment. ]
    Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256876


Contacts
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Contact: Lynn Ghijselings, MD +3293321353 lynn.ghijselings@uzgent.be
Contact: Anne-Françoise Spinoit, Professor +3293326495 annefrançoise.spinoit@uzgent.be

Locations
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Belgium
University Hospital Ghent Recruiting
Gent, East-Flanders, Belgium, 9000
Contact: Lynn Ghijselings, MD    +3293321353    lynn.ghijselings@ugent.be   
Contact: Anne-Françoise Spinoit, MD, PhD    +3293326495    annefrançoise.spinoit@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Anne-Françoise Spinoit, Professor University Hospital, Ghent
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Urologie, Professor Dr. Anne-Françoise Spinoit, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04256876    
Other Study ID Numbers: EC/2018/1267
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Disease
Pathologic Processes
 Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations