Evaulation of the clinical efficacy and safety of the combined administration of Imidafenacin and Tamsulosin in BPH patients (in which OAB symptoms remain) who did not respond to alpha-1 blocker monotherapy.

Evaulation of the clinical efficacy and safety of the combined administration of Imidafenacin and Tamsulosin in BPH patients (in which OAB symptoms remain) who did not respond to alpha-1 blocker monotherapy. - Addition Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005012

Enrollment

300

Registered

2011-02-04

Start date

2010-10-01

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

Tamsulosin 0.2mg will be orally administered once a day after breakfast and Imidafenacin 0.1mg will be administered orally twice a day, once after breakfast and dinner for 52 weeks. Tamsulosin 0.2mg w

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1)Benign prostatic hyperplasia (2)Patients who have overactive bladder even after administering Tamsulosin for more than 8 weeks (3)Outpatients who are 50 years older (4)Residual urine volume is less than 50mL (5)Prostate volume is more than 20mL (6)Patients from whom we have received written consent

Exclusion criteria

Exclusion criteria: (1)Patients who have administered prohibited substances or who have administered prohibited therapy in the 8 weeks prior to the 1st period (2)Patients who changed the dosage or usage of a restricted medicine in the specified period before the 1st period (3)Patients with anuresis (4)Patients with prostate cancer, neurogenic bladder, urethra stricture, chronic prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis (5)Patients with serious cardiac disorder, serious liver dysfunction and serious kidney dysfunction (6)Patients with orthostatic hypotension (7)Patients with pyloristenosis,constriction of dodecadactylon, construction of enteron and adynamic ileus (8)Patients with deterioration of enterokinesis (9)Patients with angle-closure glaucoma (10) Patients with myasthenia gravis. (11) Patients in which it has been confirmed that Qmax is less than 5mL/s. (12)Patients with Polyuria. (13)Any other patients who are regarded as unsuitable for this study by the investigator

Design outcomes

Primary

Measure	Time frame
Change of total OABSS score	—

Countries

Japan

Outcome results

None listed

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