Status:
UNKNOWN
Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Bladder, Overactive
Eligibility:
FEMALE
18+ years
Brief Summary
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 b...
Detailed Description
Currently, Botox injection is one of the second-line treatments for urinary incontinence by idiopathic overactive bladder. Multiple studies have shown that Botox at the dose of 50UI is effective but n...
Eligibility Criteria
Inclusion
- Female
- Age ≥ 18 yo
- Refractory idiopathic overactive bladder
- Eligibility to an injection treatment
- Capacity to perform clean intermittent catheterization
Exclusion
- 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
Key Trial Info
Start Date :
June 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04075578
Start Date
June 26 2019
End Date
May 1 2020
Last Update
September 4 2019
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003