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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxybutynin | Active Comparator |
| |
| TENS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Other | oxybutynin |
| |
| medical device Urostim |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elodie Haraux, Pr | Contact | 33+322836787 | Haraux.elodie@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Amiens | Recruiting | Amiens | France |
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| Device |
medical device used to deliver posterior tibial nerve stimulation (PTNS) |
|
| at 3 months |
| variation of tolerance between both groups | at 6 months |
| variation of compliance between both groups | variation of compliance between both groups | at 3 months |
| variation of compliance between both groups | variation of compliance between both groups | at 6 months |
| variation of long-term efficacy between both groups | at 12 months |
| variation of long-term efficacy between both groups | 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. | at 24 months |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
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