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Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia

Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia - Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030560
Enrollment
120
Registered
2017-12-25
Start date
2016-08-22
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 hyperplasia

Interventions

A monotherapy group, which continuously received 5 mg tadalafil daily for 8 weeks. An add-on group, which received 5mg tadalafil daily and 50 mg mirabegron daily for 4 weeks after 5 mg tadalafil daily

Sponsors

Division of Urology, Department of Surgery, Tottori University Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: The study included men with benign prostatic hyperplasia. Inclusion criteria are total OABSS 3 or greater with urinary urgency at least once per week, IPSS question 7 score 2 or greater and age 50 years or greater.

Exclusion criteria

Exclusion criteria: Study exclusion criteria are post-void residual urine volume greater than 100 ml, acute urinary retention, neurogenic bladder dysfunction, severe bladder diverticulum or urethral stricture, urinary tract malignant disease, previous intrapelvic irradiation, renal or hepatic impairment, severe cardiac disease, or considered unsuitable for the trial by doctors.

Design outcomes

Primary

MeasureTime frame
Overactive bladder symptom score (OABSS)

Secondary

MeasureTime frame
Number of night urination International prostate symptom score Overactive bladder-questionnaire (OAB-q) Nocturia-quality of life (N-QOL)

Countries

Japan

Contacts

Public ContactMasashi Honda

Department of Surgery, Tottori University Faculty of Medicine Dvision of Urology

honda@tottori-u.ac.jp0859-38-6607

Outcome results

None listed

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