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

UMIN ID: UMIN000002344

Registered date:17/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Overactive Bladder
• Date of first enrollment: 2009/05/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

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

Outcome(s)

• Primary Outcome: 1) Mean freaquency of nocturnal mictrition, 2) N-QOL, 3) Pittsburgh Sleep Quality Index)
• Secondary Outcome: 1) 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 minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1) 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

• Primary Sponsor: Osaka-Hokuriku maleLUTS Conference Secretariat
• Secondary Sponsor: Osaka Medical College Osaka City Univ. Osaka Univ. Kanazawa Medical Univ. Kanazawa Univ. Kansai Medical Univ. Kinki Univ. University of Toyama University of Fukui and the related facilities
• Source(s) of Monetary Support: None