Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT07030803
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT07030803
Study Brief:
Protocol Section:
NCT07030803