Bladder Instillation of Botox With EMDA for OAB - a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in number of leakage episodes
研究概览
简要总结
Instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder
详细描述
Pilot study to evaluate the effect of instillation treatment with onabotulinumtoxin A (BOTOX®) in the urinary bladder using Electromotive Drug Application (EMDA) in women with overactive bladder.
15 women with therapy-resistant OAB will be included. All patients must be qualified for conventional cystoscopic Botox injection. The study is not randomized or blinded. Follow-up time is six months with voiding charts and three questionnaires (Urinary Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) as well as a satisfaction with treatment Visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed consent form signed
- •OAB/urgency incontinence of at least 3 months duration
- •Conservative treatment (medicines, electrical stimulation) has been tried without sufficient benefit
- •There is indication for cystoscopic injection treatment with Botox®
- •More than 3 months since any previous treatment with Botox®
- •Detrusor overactivity documented by cystometry is desirable, but not obligatory
排除标准
- •Age below 18 years
- •Mixed incontinence with predominant stress component
- •Insufficient understanding of Norwegian and / or unable to fill out the necessary forms
- •Ongoing urinary tract infection (UTI) (defined as positive urine stix (nitrite and leucocytes) with symptoms of UTI) must be treated before inclusion.
- •Any contraindication stated in the Summary of product characteristics (SPC) for Botox
研究组 & 干预措施
Treatment with Botox
Onabotulinum toxin A. 200 units of Botox installed into the bladder by catheter.
干预措施: onabotulinum toxin A (Drug)
结局指标
主要结局
Change in number of leakage episodes
时间窗: 24 hours
Measured with a 24-hour voiding chart
次要结局
- Change in mean voided volume(24 hours)
- Change in grams leakage(24 hours)
- Change in flow rate(4 weeks)
- Change in number of voids(24 hours)
- Change in Urinary Distress Inventory-6 score (UDI-6)(6 months)
- Change in Incontinence Impact Questionnaire-7 score (IIQ-7)(6 months)
- Change in International Consultation on Incontinence Questionnaire-Short Form score (ICIQ-SF)(6 months)
研究者
Dr Hjalmar A Schiotz, MD, PhD
Senior consultant gynecologist
The Hospital of Vestfold