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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002344

Enrollment

300

Registered

2009-08-17

Start date

2009-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Interventions

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 sl

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients has urinary urgency once a week or more and also has nocturia (Question 2 of OABSS>=2 and Question 7 of IPSS>=2) after alpha-blocker treatment over the past 1 month or longer. (be available to all ages)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
1) Mean freaquency of nocturnal mictrition, 2) N-QOL, 3) Pittsburgh Sleep Quality Index)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYasushi Miyagawa

Osaka-Hokuriku maleLUTS Conference Secretariat(Osaka University Hospital) Urology

miyagawa@uro.med.osaka-u.ac.jp06-6879-3531

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026