(VAPOR trial)

JRCT ID: jRCTs071190040

Registered date:08/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Overactive bladder
• Date of first enrollment: 27/01/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Patients are randomly assigned in a 1:1 ratio to vibegron therapy or observation groups after following adjustment factors; age and an average urinary frequency per day at the time of eligibility judgement.

Outcome(s)

• Primary Outcome: Difference between vibegron therapy and observation groups in the change of average urinary frequency per day from baseline to the end of treatment

Secondary Outcome

1) Difference between vibegron therapy and observation groups in the change from baseline to the end of treatment in the scores as follow;
1. Parameters in bladder diary (urge to urinate, urge incontinence, nocturnal urinary frequency, volume per void)
2. Maximum urinary flow rate (Qmax)
3.Post-void residual volume
2) The changes from baseline to the end of treatment in the following scores;
1.Individual scores of OABSS
2. Total score of IPSS, urine storage symptom score of IPSS and urination symptom score of IPSS
3.IPSS-QOL score
4.OAB-q score
3) Background factors that affect changes in each score
4) Background factors that affect therapeutic effects
5) Subgroup analysis according to patient characteristics

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Seki Narihito
• Source(s) of Monetary Support: KYORIN Pharmaceutical Co., Ltd.