Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial

Not Applicable

Recruiting

• Conditions: Overactive Bladder

• Registration Number: JPRN-UMIN000010327
• Lead Sponsor: Osaka-Hokuriku maleLUTS Conference

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-27
• Study Completion: 2015-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1) Urinary retention within a year 2) Residual urine >=50mL 3) Strong 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, circadian rhythm disorder, and irregular lifestyle 8) Bladder training conducted over the past 10 days 9) Active acute urinary tract infection 10) Hormones or 5 alpha-reductase inhibitor started to have within the past six months 11) Contraindication to imidafenacin (primary angle-closure glaucoma, urinary retention, obstructive intestinal disease, paralytic ileus, gastrointestinal atony, myastania gravis) 12) Contraindication to mirabegron (severe heart disease, severe liver dysfunction, treatment of flecainide or propaphenone) 13) Untreated severe hypertension (more than Class II in JSH 2009, SBP>=160mmHg or DBP>= 100mmHg) 14) Judged as being unsuitable for the trial by physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified