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

Not Applicable

• Conditions: Overactive Bladder

• Registration Number: JPRN-UMIN000002344
• Lead Sponsor: Osaka-Hokuriku maleLUTS Conference Secretariat

Brief Summary

Add-on anticholinaergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving alpha 1- blocker treatmen: a multi-centre, prospective, randomised study. A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving alpha 1-blocker treatment. Anticholinergic admiistration nightly could reduce the nocturnal urine volume.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-17
• Study Completion: 2011-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Mean freaquency of nocturnal mictrition, 2) N-QOL, 3) Pittsburgh Sleep Quality Index)

Secondary Outcome Measures

Name	Time	Method
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