Clinical trial NCT04075578: Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU)
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder, Overactive
Keywords: idiopathic overactive bladder
Botox
Onabotulinum toxinA
50 units
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female ≥ 18 yo, suffers from urinary incontinence by idiopathic overactive bladder, inadequately treated by 2 anticholinergic medicines during a period of 3 months for each of them or stopped for intolerance or adverse events

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 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)

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 not for a long time. Maximum efficiency is about two weeks and until about twelve weeks compared to the dose between 100UI and 300UI that shown an efficiency until twenty-four at thirty-six weeks. But it's not without consequence since the side effects are more numerous increasing the dose. The most frequent are urinary retention with necessary to perform clean intermittent catheterization and urinary infection.

This dose at 50UI is therefore more a test to assess the patient's tolerance to the product, as recommended by the product marketing authorization.

So, through this evaluation of professional practices, investigators would like to evaluate the patient satisfaction treated in hospital, with a first dose at 50UI.

Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥ 18 yo
* Refractory idiopathic overactive bladder
* Eligibility to an injection treatment
* Capacity to perform clean intermittent catheterization

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of the life quality by the KHQ (King's Health Questionnaire)
timeFrame: Week 6
Secondary outcomes:
measure: Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire
timeFrame: Week 2
measure: Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire
timeFrame: Week 12
measure: Evaluation of the life quality by the KHQ (King's Health Questionnaire)
timeFrame: Week 2
measure: Evaluation of the life quality by the KHQ (King's Health Questionnaire)
timeFrame: Week 12
measure: Patient experience's evaluation of the local anaesthesia and outpatient care thanks to the EVAN-LR (Evaluation du Vécu de l'ANesthésie Loco-Régionale) questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Sandrine CAMPAGNE-LOISEAU, PH
role: PRINCIPAL_INVESTIGATOR
References: