NIPH Clinical Trials Search

UMIN ID: UMIN000002344

Registered date:17/08/2009

Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedOveractive Bladder
Date of first enrollment2009/05/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)continuous oral administration of alpha-blocker (be available to any medicine) Any alpha-blocker plus imidafenacin 0.2mg/day bid. Any alpha-blocker plus imidafenacin 0.1mg/day administration before sleep


Primary Outcome1) Mean freaquency of nocturnal mictrition, 2) N-QOL, 3) Pittsburgh Sleep Quality Index)
Secondary Outcome1) OABSS 2) IPSS&QOL 3) mean night-time urine (mean nocturnal urine volume) 4) maximum voided volume 5) residual urine volume 6) adverse events and side-effects

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
Include criteria
Exclude criteria1) Urinary retention within a year 2) Residual urine >=50mL 3) Suspect of prostate cancer 4) Treatment of any anti-muscarinic agent or beta-stimulants within a month. 5) Indwelling catheter or self intermittent urinary catherization 6) Diseases that affect nocturia (sleep apnea syndrome, Restless legs syndrome, insomnia etc.) 7) The shift work and circadian rhythm disorder, patients with irregular lifestyle 8) Bladder training conducted over the past 10 days 9) Active urinary tract infection 10) Having been given hormones or 5 alpha-reductase inhibitor within the past six months 11) Contraindication to Imidafenacin (Primary angle-closure glaucoma, urinary retention, Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis) 12) Judged as being unsuitable for the trial by the researcher.

Related Information


public contact
Name Yasushi Miyagawa
Address Yamadaoka 2-2, Suita, Osaka 565-0871 Japan
Telephone 06-6879-3531
Affiliation Osaka-Hokuriku maleLUTS Conference Secretariat(Osaka University Hospital) Urology
scientific contact
Name Osamu Yokoyama
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui Japan
Telephone 0776-61-3111
Affiliation Faculty of Medical Science, University of Fukui Urology