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

Not Applicable

• Conditions: Benign prostatic hyperplasia patients with overactive bladder despite tadalafil treatment

• Registration Number: JPRN-UMIN000021959
• Lead Sponsor: Kawahara Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The OABSS total score from baseline to 8 weeks

Secondary Outcome Measures

Name	Time	Method
(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