Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for patients with benign prostatic enlargement complicated by overactive bladder after alpha1-blocker administration, A randomized, prospective trial using a urodynamic study

Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for patients with benign prostatic enlargement complicated by overactive bladder after alpha1-blocker administration, A randomized, prospective trial using a urodynamic study - Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for BPH/OAB

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026394

Enrollment

100

Registered

2017-03-10

Start date

2017-06-05

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

benign prostatic enlargement complicated by overactive bladder

Interventions

The administration of fesoterodine The administration of mirabegron

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) patinets who have taken alpha-1 blocker for more than 12 weeks 2) total OAB symptom scores (OABSS) more than 2 and urinary urgency episodes more than 1 per week 3) outpatinets more than 50 years old

Exclusion criteria

Exclusion criteria: Patients were excluded if they received oral treatment with propafenone hydrochloride, flecainide acetate, anticholinergic agents, antidepressants, anti-anxiety agents, or sex hormonal agents; had neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; and had severe cardiac disease, renal dysfunction (serum creatinine level more than 2 mg/dL), and hepatic dysfunction (aspartate and alanine aminotransferase concentrations more than twice the normal values).

Design outcomes

Primary

Measure	Time frame
the change of storage and voiding function between the two add on therapies after 12 weeks' treatment	—

Secondary

Measure	Time frame
the change of subjective symptoms regarding lower urinary tract symptoms between the two add on therapies after 12 weeks' treatment	—

Countries

Japan

Contacts

Public ContactYoshihisa Matsukawa

Nagoya University Graduate School of Medicine Department of Urology

yoshi44@med.nagoya-u.ac.jp052-744-2985

Outcome results

None listed

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