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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the life quality by the KHQ (King's Health Questionnaire)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 yo
- •Refractory idiopathic overactive bladder
- •Eligibility to an injection treatment
- •Capacity to perform clean intermittent catheterization
排除标准
- •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
研究组 & 干预措施
female with urinary incontinence
Female ≥ 18 years, 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
干预措施: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States (Drug)
结局指标
主要结局
Evaluation of the life quality by the KHQ (King's Health Questionnaire)
时间窗: 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
次要结局
- Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire(Week 12)
- Evaluation of the life quality by the KHQ (King's Health Questionnaire)(Week 12)
- 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)