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NCT Number: NCT07030803

Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Posterior Tibial Nerve Stimulation Signs and Symptoms Transcutaneous Neurostimulation Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, France

Location status: Recruiting

Location contact

Elodie Haraux, Pr

CONTACT

[email protected]

33+322836787

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Oxybutynin

Other

oxybutynin

medical device Urostim

Device

medical device used to deliver posterior tibial nerve stimulation (PTNS)

Primary outcomes

  1. 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.

Secondary outcomes

  1. variation of treatment duration between both groups

    Time frame: at 6 months

  2. variation of time to treatment efficacy between both groups

    Time frame: at 6 months

  3. variation of tolerance between both groups

    Time frame: at 3 months

  4. variation of tolerance between both groups

    Time frame: at 6 months

  5. variation of compliance between both groups

    Time frame: at 3 months

    variation of compliance between both groups

  6. variation of compliance between both groups

    Time frame: at 6 months

    variation of compliance between both groups

  7. variation of long-term efficacy between both groups

    Time frame: at 12 months

  8. variation of long-term efficacy between both groups

    Time frame: at 18 months

  9. variation of long-term efficacy of AOB frequency between both groups

    Time frame: at 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie Haraux, Pr

CONTACT

[email protected]

33+322836787

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • University Hospital, Rouen

Registry information

Acronym: HAV-O-TENS

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 22, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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