Evaluation of selective beta3-adrenoreceptor agonist vibegron treatment for residual overactive bladder symptoms after photoselective, contact-laser, and thulium-laser vaporization of the prostate: A single-centre randomized controlled trial (VAPOR trial)

Seki Narihito0 个研究点目标入组 60 人开始时间: 2020年1月8日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Male patients >= 40 years
•2) Patient who has passed 12 weeks or more and less than 1 year after PVP,CVP or ThuVAP for BPH at the time of obtaining written informed consent
•3)Patient with an IPSS-QOL score >= 2
•4) Patient with a OABSS >= 3, a OABSS question1 score >=1 and a OABSS question3 score >= 2
•5) Patient who can record a bladder diary
•6) Patient with an average urinary frequency of 8 times or more per day at baseline (0 week)
•7) Patient who provided written informed consent

•1) Patient has post-void residual volume >= 100mL
•2) Patient who is placed a catheter for a long time after undergoing PVP,CVP orThuVAP,or those who is utilizing a self -catheterization for bladder management
•3)Patient has a complication with symptoms similar to OAB ( e g diabetes insipidus, urolithiasis, urinary tract infection, interstitial bladder cystitis, prostatitis) and patient who is judged affectable for enrollment by principle investigator or sub investigator
•4) Patient with only stress incontinence
•5) Patient has a history of injury, surgery or multiple sclerosis that could affect the lower urinary tract or its
•nerve supply
•6)Patients with bladder or prostate cancer and undergoing or scheduled radiation therapy
•7) Patient who is receiving a medication therapy and or a behavioral therapy for OAB at enrollment
•8) Patient who has received a drug that affect lower urinary tract symptoms ( e g alpha1 blocker, PDE5 inhibitor, anticholinergic agent or beta-adrenergic receptor agonist) within the last 2 months
•9) Patient who received 5alpha-reductase inhibitor within the last 3 months
•10) Patient who is judged unsuitable for enrollment by principle investigator or sub investigator

发起方

Seki Narihito