Pilot investigation of the effect of the Memokath 028 Prostate® stent on quality of life in patients with urethral obstruction a comparison with long term catheter

Royal Devon and Exeter Foundation Trust (UK)0 个研究点目标入组 60 人开始时间: 2012年4月11日最近更新: 2018年2月19日

试验速览

暂无简介。

•1. Men aged 50 years and older
•2. Acute or chronic urinary retention initially treated with a urethral catheter
•3. Considered to be medically unfit for, or to present a significant risk for TURP, such that the admitting urologist would consider a long term catheter to be the standard management.
•4. Considered by the admitting urologist and trial team to be medically suitable to be managed with a long term prostatic stent

•1. Inability or unwillingness to sign informed consent form / any written questionnaire and participate in investigation due to physical or mental limitations
•2. Meatal or urethral strictures that cannot be opened to 26 Fr
•3. Urethral diverticuli
•4. Any known condition requiring transurethral manipulations within 6 months after stent placement
•5. Bladder stones, bladder or urethral carcinoma
•6. Prior TURP or other surgical intervention for BPH within the last year
•7. Presence of another urological prosthesis
•8. Unresolved major symptomatic medical problem which would interfere with the investigation, including any and all disorders contraindicating insertion and/or removal procedure
•9. Life expectancy < 1 year
•10. Concurrent participation in another clinical trial during the period of this investigation

发起方

Royal Devon and Exeter Foundation Trust (UK)