NL-OMON46848已完成不适用
An explorative analysis of the effect of a beta 3 adrenoreceptor agonist (Mirabegron) on urethral pressure variations during filling cystometry. - Effect Mirabegron on urethral pressure variation during filling cystometry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •>18 years of age.
- •Mentally fit to consent.
- •(Referred with) Bothersome OAB symptoms (standard symptom and bother score)
- •Voiding diary with total urine production in 24 hour (morning to morning) <2200mL
- •Treating physician has indicated treatment with B3AA Mirabegron
- •Signed informed consent
- •May have had *unsatisfying- treatment with antimuscarinergic medication
- •Willing to stop medication for lower urinary tract dysfunction 2 days before urodynamic investigation (at entry of study)
- •Willing to start B3AA *study medication- after initial urodynamic investigation
排除标准
- •* Sediment + or clinical signs of UTI at the start of the urodynamic investigation
- •* Necessity to perform CIC or significant post void residual (>100mL).
- •* Significant voiding abnormalities; bladder outlet obstruction (UDI >grade 1 or BOOI >20) or underactive or acontractile detrusor.
- •* Unwilling or unable * according to treating physician- to stop current treatment for lower urinary tract dysfunction.
- •* Treatment with intradetrusor botulinum toxin less than one year before urodynamic investigation (whether or not symptomatically effective).
- •* Having a contraindication for treatment with B3AA : severe renal impairment with GFR <15 mL/min/1.73m2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C)
- •* Pregnancy or breastfeeding.
研究者
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