Overactive Bladder (OAB), Posterior Tibial Nerve Stimulation, Transcutaneous Neurostimulation
Conditions
Keywords
Overactive Bladder, transcutaneous neurostimulation, posterior tibial nerve stimulation
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.
Interventions
OTHEROxybutynin
oxybutynin
DEVICEmedical device Urostim
medical device used to deliver posterior tibial nerve stimulation (PTNS)
Sponsors
University Hospital, Rouen
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of DVISS score between PTNS treatment group and oxybutynin group | 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
| Measure | Time frame | Description |
|---|---|---|
| variation of time to treatment efficacy between both groups | at 6 months | — |
| variation of tolerance between both groups | at 3 months | — |
| variation of treatment duration between both groups | at 6 months | — |
| variation of long-term efficacy between both groups | at 12 months | — |
| variation of long-term efficacy of AOB frequency between both groups | 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. |
| variation of compliance between both groups | at 3 months | variation of compliance between both groups |
Countries
France
Contacts
Primary ContactElodie Haraux, Pr
Outcome results
None listed