Overactive Bladder SyndromeTaPaSNCT04256876
TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I)
A study testing TTNS in people with Overactive Bladder Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- TTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Nov 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- 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
- Overactive Bladder Syndrome
- Being tested
- TTNS, TTNS Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTNSDevice
Also called Transcutaneous tibial nerve stimulation
See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
TTNS ShamDevice
Also called Sham therapy
See section 'arms'
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: TTNS Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean voided volume per void
Difference in mean voided volume per void in percentage
Measured: 12 weeks
Secondary outcomes (5)
Maximum voided volume (ml)
Maximal voided volume per void ( ml) .
Measured: 12 weeks
Number of urgency incontinence episodes / 24 h.
Reduction in number of incontinence episodes per 24 hour
Measured: 12 weeks
Daytime voiding frequency
Mean voiding frequency per day
Measured: 12 weeks
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?
Measured: 12 weeks
Time to recurrence
Time to complete or partial relapse to baseline symptoms after 12 weeks of treatment during the observational period of 6 weeks.
Measured: At 12 weeks of treatment + at 6 weeks of observational period without treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized-controlled superiority trial: TTNS(Active treatment) vs. Sham TTNS (placebo)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Françoise Spinoit, Professor, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256876
- Sponsor's protocol ID
- EC/2018/1267
- Acronym
- TaPaS
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25979217Patidar 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.
PubMed 26279104Ghijselings 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.
PubMed 33810804
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04256876
- Acronym / sponsor ID
- TaPaS / EC/2018/1267
- Conditions
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized-controlled superiority trial: TTNS(Active treatment) vs. Sham TTNS (placebo)
| Arm | Type | Receives |
|---|---|---|
| Active TTNS | Active comparator | Device: TTNSChildren 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. |
| TTNS sham intervention | Sham comparator | Device: TTNS ShamChildren 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTNSAlso: Transcutaneous tibial nerve stimulationSee section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes. | Device | Active TTNS |
| TTNS ShamAlso: Sham therapySee section 'arms' | Device | TTNS sham intervention |
Primary outcome
Mean voided volume per void
Time frame: 12 weeks
Difference in mean voided volume per void in percentage
5 secondary outcomes
Maximum voided volume (ml)
Time frame: 12 weeks
Number of urgency incontinence episodes / 24 h.
Time frame: 12 weeks
Daytime voiding frequency
Time frame: 12 weeks
Satisfaction on urinary symptoms reported by parents
Time frame: 12 weeks
Time to recurrence
Time frame: At 12 weeks of treatment + at 6 weeks of observational period without treatment.
Results and safety
The study was stopped early (reason given: due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 25979217Boudaoud 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.
- Results publication: PubMed 26279104Patidar 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.
- Derived from this study: PubMed 33810804Ghijselings 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Françoise Spinoit, Professor principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTNS in people with Overactive Bladder Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to the corona pandemic, live patient contact was no longer possible. As a result, the study had to be stopped early.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean voided volume per void (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.