Informations générales (source: ClinicalTrials.gov)
Evaluation of Professional Practices in Botulinum Toxin Type A Intradetrusor Injection, at the Dose of 50 Units for the Treatment of Urinary Incontinence by Refractory Idiopathic Overactive Bladder (TOX50IUU)
Observational
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
juin 2019
mai 2020
29 juin 2024
Considering that the 2013 Hermieu's guidelines differs from the product marketing
authorization delivered in November 2014, the primary endpoints is to evaluate life
quality by questionnaires at the baseline time, and after two, six and twelve weeks of
treatment in patients suffer from urinary incontinence by refractory idiopathic
overactive bladder and treated by Botox® at the dose of 50UI (international units)
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Female
- Age ≥ 18 yo
- Refractory idiopathic overactive bladder
- Eligibility to an injection treatment
- Capacity to perform clean intermittent catheterization
- Female
- Age ≥ 18 yo
- Refractory idiopathic overactive bladder
- Eligibility to an injection treatment
- Capacity to perform clean intermittent catheterization
- Protected adults (under trusteeship, guardianship or judicial protection)
- Patients under anticholinergics for an other desease (psychiatric, neurologic for
example)
- Known hypersensitivity or at risk of hypersensitivity to botulinum toxin type A like
myasthenic syndrom
- Patients who suffer from an overactive bladder with a known cause (neurological,
urological condition)
- urinary infection under treatment < 48 hours before Botox® injections
- Suspicious looking bladder requiring biopsies during the cystoscopy
- Pregnant or breastfeeding women
- Language barriers