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

  • STATUS
    Recruiting
  • End date
    Dec 7, 2023
  • participants needed
    300
  • sponsor
    Gangnam Severance Hospital
Updated on 4 September 2021
alpha blocker
benign prostatic hyperplasia
hyperplasia

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.

Description

Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5 reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.

The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (30% decrease from baseline) and prostate volume (35% decrease from baseline).

Details
Condition Prostate Disorders, Prostatic disorder, benign prostatic hyperplasia, benign prostatic hyperplasia (bph), Benign Prostatic Hyperplasia (Enlarged Prostate), Benign prostatic hypertrophy
Treatment alpha-blocker or 5-ARI withdrawal, Maintenance of alpha-blocker and 5-ARI
Clinical Study IdentifierNCT05023824
SponsorGangnam Severance Hospital
Last Modified on4 September 2021

Eligibility

Yes No Not Sure

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
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