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Safety and efficacy of mirabegron on nocturia and quality of sleep in Japanese patients with overactive bladder.

Safety and efficacy of mirabegron on nocturia and quality of sleep in Japanese patients with overactive bladder. - Efficacy of mirabegron on nocturia and sleep disorder in Japanese patients with overactive bladder.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012869
Enrollment
100
Registered
2014-01-16
Start date
2012-10-01
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

Mirabegron

Sponsors

Fujita Health University
Lead Sponsor
Nagoya Ekisaikai Hospital Nagoya Memorial Hospital Minami Seikyo Hospital Chita city Hospital Aoyama Hospital Nakatugawa City Hospital Shizuoka Red Cross Hospital Hamamatsu Red Cross hospital Izumitani Fureai Clinic Mikawa Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Male and female patients with overactive bladder.(Q3:2over and OABSS total score:3over) 2 Patients attending physician has determined is reasonable to test participation. 3 The contents of the questionnaire can be understood without the aid of others. 4 Patients who consent in writing.

Exclusion criteria

Exclusion criteria: 1 Patients with a history of hypersensitivity to any component of this drug 2 Patients with severe heart disease /Heart rate increase, etc. have been reported, and Symptoms may be worse. 3 Women suspected of being pregnant and pregnant women 4 nursing woman. /Milk transfer has been observed animal experiments(in rats).In addition, this drug in lactation When administered to dams, reduced body weight gain and lower survival rates have been observed in the offspring. 5 Severe liver dysfunction patients (Child-Pugh score 10 or more) 6 Patients with propafenone hydrochloride or during flecainide acetate administration during. 7 Some of the urinary tract infection with active or chronic bacterial prostatitis. 8 Patients carried out pelvic radiation therapy 9 patients suspected prostate cancer by digital rectal examination or PSA. 10 Patienst with urethral stricture 11 Other things, the attending physician has determined to be inappropriate

Design outcomes

Primary

MeasureTime frame
evaluation of OABSS at baseline and 12weeks.

Secondary

MeasureTime frame
bladder diary N-QOL AIS ESS

Countries

Japan

Contacts

Public ContactHitomi Sasaki

Fujita Health University Urology

sasakih@fujita-hu.ac.jp0562-93-9257

Outcome results

None listed

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