Bladder, Overactive
Conditions
Keywords
idiopathic overactive bladder, Botox, Onabotulinum toxinA, 50 units
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.
Interventions
DRUGOnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States
Botox® intradetrusor injections, with a rigid cystoscope, under local anaesthesia performed by Lidocaïne 2% diluted in 30ml of bicarbonate 14‰. 20 injections of 0,5ml each will be heterogeneously administrated into the bladder wall, sparing the trigone
Sponsors
University Hospital, Clermont-Ferrand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the life quality by the KHQ (King's Health Questionnaire) | Week 6 | Patients will have to answer the questionnaire at home depending the symptoms that they feel at 6 weeks. The data will then be collected by phone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire | Week 2 | Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected by phone. The data will then be collected and analysed. |
| Evaluation of the life quality by the KHQ (King's Health Questionnaire) | Week 2 | Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected by phone at 2 weeks. The data will then be collected and analysed |
| 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 | Day 1 | Patients will have to answer the questionnaire before the return home just after the injection session to assess their experience concerning local anaesthesia and outpatient management. |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed