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

NCT07030803 | Recruiting

• 1 other identifier: PI2023_843_0176
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Overactive Bladder; transcutaneous neurostimulation; posterior tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  at 3 months

Secondary Outcomes (9)

• variation of treatment duration between both groups

  at 6 months

• variation of time to treatment efficacy between both groups

  at 6 months

• variation of tolerance between both groups

  at 3 months

• variation of tolerance between both groups

  at 6 months

• variation of compliance between both groups

  at 3 months

Study Arms (2)

oxybutynin

ACTIVE COMPARATOR

Other: Oxybutynin

TENS

EXPERIMENTAL

Device: medical device Urostim

Interventions

Oxybutynin OTHER

oxybutynin

oxybutynin

medical device Urostim DEVICE

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

TENS

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Neurological cause of bladder dysfunction,
• History of pelvic surgery,
• Significant post-micturition residual (\> 10% of micturition),
• Pregnant or breast-feeding adolescents
• Severe constipation resistant to treatment (Rome IV),
• Contraindication to oxybutynin
• Contraindication to the use of TENS (Urostim)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Rouen: collaborator

Study Sites (1)

CHRU Amiens

Amiens, France

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elodie Haraux, Pr

CONTACT

33+322836787; Haraux.elodie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: June 22, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)