Randomised trial of detrusor botulinum toxin injection compared to placebo in idiopathic detrusor overactivity

niversity Hospitals of Leicester NHS Trust (UK)0 个研究点目标入组 240 人开始时间: 2005年5月26日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. 8 weeks of continued treatment with oral anticholinergic medication, with a screening Patient Global Impression of Improvement (PGI-I) scale score of 'a little better' or 'worse'. This point of the scale represents a reduction of incontinence episode frequency of around 50% (Slack, unpublished data).
•2. 8 weeks of continued treatment, with a verbal response that the treatment has not provided acceptable improvement
•3. Treatment stopped because of side effects within 8 weeks
•4. Previous treatments stopped because of lack of efficacy, and currently receiving no treatment
•Additionally, patients will report at least 8 voids per 24 hours, with at least 2 urgency episodes per 24 hours. Urgency episodes will be defined as those rated as 'moderate' or higher on the Urgency severity scale, and urge incontinence episodes will be defined as recorded leakage in association with an urgency episode.

•1. Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
•2. Patients with pre-existing voiding dysfunction (flow rate less than 5th centile, or post void residual volume greater than 100 ml)
•3. Patients fulfilling the exclusion criteria for the licensed indications of botulinum toxin (myasethenia gravis and Eaton Lambert syndrome, or allergy to constituents of BOTOX® injection)
•4. Patients with co-existing urodynamic stress incontinence

发起方

niversity Hospitals of Leicester NHS Trust (UK)