Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder

Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder - Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021959

Enrollment

Registered

2016-04-19

Start date

2016-04-19

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 patients with overactive bladder despite tadalafil treatment

Interventions

Intervention group: imidafenacin(0.1 mg twice a day) will be additionally prescribed for 8 weeks to patients currently taking tadalafil(5mg/day)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients must satisfy the following conditions at the first visit: (1) 50 years old or above (at the time of obtaining consent) (2) Overactive bladder despite taking tadalafil 5 mg per day for 4 weeks or more (OAB definition: 2 points or more for question 3 of the OABSS and 3 points or more for the OABSS total score) (3) Prostate volume of at least 20 mL (4) Outpatient (5) Provided written consent for participation in this study

Exclusion criteria

Exclusion criteria: Patients who meet any of the following conditions at the first visit are excluded: (1) Residual urine volume of 100 mL or more (2) Suspicion of polyuria (3) Currently have, or have a past history of, urinary retention (4) Qmax of less than 5 mL/s (5) Neoplasm of the lower urinary tract such as prostate or bladder cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, urinary tract infection, urinary tract stone, or interstitial cystitis (6) Contraindication to the prescription of tadalafil or imidafenacin (7) Severe liver dysfunction, kidney dysfunction, or heart disease (8) Pyloric, duodenal, or other intestinal obstruction, decreased gastrointestinal motility or distention, paralytic ileus, closed angle glaucoma, or myasthenia gravis (9) Taking a prohibited concurrent medication within 4 weeks prior to starting the study (5&alpha-reductase inhibitor, sex hormone agent within 6 months) (10) Received a prohibited concurrent therapy within 8 weeks prior to starting the study (11) Change in dose or regimen within 8 weeks prior to starting the study of a concurrent restricted medication or therapy (12) Otherwise, determined to be inappropriate by the doctor

Design outcomes

Primary

Measure	Time frame
The OABSS total score from baseline to 8 weeks	—

Secondary

Measure	Time frame
(1) OABSS subscore (2) IPSS total, storage, voiding, QOL score (3) BII (4) Residual urine volume (5) Maximum urinary flow rate (6) Adverse events and side effects	—

Countries

Japan

Contacts

Public ContactKazuya Kawahara

Kawahara Clinic Department of urology

kazi@kawahara.or.jp099-564-5181

Outcome results

None listed

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