Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH

• Status: Recruiting
• Trial end date: 2023-12-07
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gangnam Severance Hospital
• Treatments: Adrenergic alpha-Antagonists

Criteria

Inclusion Criteria:

• Men aged ≥50 or <80 years AND

• On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND

• IPSS score (≤30% decrease from baseline) AND

• Prostate volume (≤35% decrease from baseline)

Exclusion Criteria:

• Suspected prostate cancer (PSA density >0.15 ng/ml/cc) requiring specific management

• On-going prostatitis or urinary retention

• Acontractile detrusor

• Neurogenic lower urinary tract dysfunction

• Urethral stenosis

• Patient unable or unwilling to provide written informed consent