A prospective open study evaluating the use of botulinum toxin in patients with overactive bladder as an alternative to other conservative treatments.

Gwent Healthcare NHS Trust0 个研究点目标入组 100 人开始时间: 2005年10月4日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Inclusion criteria.
•Patients with urodynamically proven detrusor overactivity. This must be on conventional CMG or VCMG - not ambulatory monitoring
•This may be of congenital, neuropathic or idiopathic aetiology.
•Previous failed treatment with conservative and standard medical therapy.
•Patients who might otherwise be considered for neuromodulation, augmentation or diversion surgery.
•A subgroup of patients with known neurogenic detrusor overactivity who already have indwelling suprapubic catheters may also be studied.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Exclusions.
•Patients < 18 years of age.
•Patients with proven bladder outflow obstruction on urodynamics.
•Any patients with generalised disorder of muscle activity eg; Myaesthenia Gravis.
•Serious concomitant illness.
•Patients with bleeding disorders.
•Pregnant or breast feeding patients.
•Patients who would not tolerate intermittent self catheterisation (this excludes the subgroup who already have indwelling suprapubic catheters).
•Patients in whom stress incontinence is the primary symptom.
•Previous failure of Botulinum toxin therapy.
•Acute urinary infection.
•Any other bladder pathology demonstrated at the time of cystoscopy (includes trauma, stones, tumour).

发起方