Overactive Bladder (OAB)HAV-O-TENSNCT07030803
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
A study testing Oxybutynin and medical device Urostim in people with Overactive Bladder (OAB) and Transcutaneous Neurostimulation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Overactive Bladder (OAB), Transcutaneous Neurostimulation, Posterior Tibial Nerve Stimulation
- What is being tested?
- Oxybutynin and medical device Urostim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6 to 16 years
- Showing signs of OAB (pollakiuria (> 8 micturitions/d and/or urgenturia(>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)
- No treatment for more than 3 months
- Urotherapy rules followed for at least 1 month
- Beneficiary of a social security plan
- Signature of consent by parents/legal guardian(s) and child's agreement
Who cannot join
- Neurological cause of bladder dysfunction,
- History of pelvic surgery,
- Significant post-micturition residual (> 10% of micturition),
- Recurrent urinary tract infections (> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.
- Pregnant or breast-feeding adolescents
- Severe constipation resistant to treatment (Rome IV),
- Contraindication to oxybutynin
- Contraindication to the use of TENS (Urostim)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens
Elodie Haraux, Pr, 33+322836787, Haraux.elodie@chu-amiens.fr
About this study
The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment.
Before inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.
- Conditions
- Overactive Bladder (OAB), Transcutaneous Neurostimulation, Posterior Tibial Nerve Stimulation
- Being tested
- Oxybutynin, medical device Urostim
- Keywords
- Overactive Bladder, transcutaneous neurostimulation, posterior tibial nerve stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninOther
oxybutynin
medical device UrostimDevice
medical device used to deliver posterior tibial nerve stimulation (PTNS)
| Study group | Role | What they receive |
|---|---|---|
| oxybutynin | Active comparator | Not described Receives: Other: Oxybutynin |
| TENS | Experimental | Not described Receives: Device: medical device Urostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of DVISS score between PTNS treatment group and oxybutynin group
DVISS score is : Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire.
The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format.
The DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD.
Measured: at 3 months
Secondary outcomes (9)
variation of treatment duration between both groups
Measured: at 6 months
variation of time to treatment efficacy between both groups
Measured: at 6 months
variation of tolerance between both groups
Measured: at 3 months
variation of tolerance between both groups
Measured: at 6 months
variation of compliance between both groups
variation of compliance between both groups
Measured: at 3 months
variation of compliance between both groups
variation of compliance between both groups
Measured: at 6 months
variation of long-term efficacy between both groups
Measured: at 12 months
variation of long-term efficacy between both groups
Measured: at 18 months
variation of long-term efficacy of AOB frequency between both groups
Long term efficacy of OAB frequency is measured with DVISS score. The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format.
The DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start5 Nov 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030803
- Sponsor's protocol ID
- PI2023_843_0176
- Acronym
- HAV-O-TENS
- Status last verified
- Nov 2025
- First submitted
- 29 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
- ClinicalTrials.gov ID
- NCT07030803
- Acronym / sponsor ID
- HAV-O-TENS / PI2023_843_0176
- Conditions
- Overactive Bladder (OAB), Transcutaneous Neurostimulation, Posterior Tibial Nerve Stimulation
- Keywords
- Overactive Bladder, transcutaneous neurostimulation, posterior tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 Jun 2025 (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.
The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment.
Before inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxybutynin | Active comparator | Other: Oxybutynin |
| TENS | Experimental | Device: medical device Urostim |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients aged 6 to 16 years
- Showing signs of OAB (pollakiuria (> 8 micturitions/d and/or urgenturia(>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)
- No treatment for more than 3 months
- Urotherapy rules followed for at least 1 month
- Beneficiary of a social security plan
Key exclusion criteria (8 listed)
- Neurological cause of bladder dysfunction,
- History of pelvic surgery,
- Significant post-micturition residual (> 10% of micturition),
- Recurrent urinary tract infections (> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.
- Pregnant or breast-feeding adolescents
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 |
|---|---|---|
| Oxybutyninoxybutynin | Other | oxybutynin |
| medical device Urostimmedical device used to deliver posterior tibial nerve stimulation (PTNS) | Device | TENS |
Primary outcome
Variation of DVISS score between PTNS treatment group and oxybutynin group
Time frame: at 3 months
DVISS score is : Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire. The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format. The DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD.
9 secondary outcomes
variation of treatment duration between both groups
Time frame: at 6 months
variation of time to treatment efficacy between both groups
Time frame: at 6 months
variation of tolerance between both groups
Time frame: at 3 months
variation of tolerance between both groups
Time frame: at 6 months
variation of compliance between both groups
Time frame: at 3 months
variation of compliance between both groups
Time frame: at 6 months
variation of long-term efficacy between both groups
Time frame: at 12 months
variation of long-term efficacy between both groups
Time frame: at 18 months
variation of long-term efficacy of AOB frequency between both groups
Time frame: at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxybutynin and medical device Urostim in people with Overactive Bladder (OAB) and Transcutaneous Neurostimulation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 France. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie Haraux, Pr (33+322836787, Haraux.elodie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of DVISS score between PTNS treatment group and oxybutynin group (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.