Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH
NCT ID: NCT05023824
Last Updated: 2021-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2020-12-08
2023-12-07
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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alpha-blocker withdrawal
receives 5-ARI monotherapy
alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
5-ARI withdrawal
receives alpha-blocker monotherapy
alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
combination therapy
receives alpha-blocker and 5-ARI
Maintenance of alpha-blocker and 5-ARI
Maintenance of alpha-blocker and 5-ARI
Interventions
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alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
Maintenance of alpha-blocker and 5-ARI
Maintenance of alpha-blocker and 5-ARI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* On-going prostatitis or urinary retention
* Acontractile detrusor
* Neurogenic lower urinary tract dysfunction
* Urethral stenosis
* Patient unable or unwilling to provide written informed consent
50 Years
80 Years
MALE
No
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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Kyo Chul Koo
Associate Professor
Principal Investigators
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Kyo Chul Koo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Barkin J, Guimaraes M, Jacobi G, Pushkar D, Taylor S, van Vierssen Trip OB. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. Eur Urol. 2003 Oct;44(4):461-6. doi: 10.1016/s0302-2838(03)00367-1.
Nickel JC, Barkin J, Koch C, Dupont C, Elhilali M. Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers. Can Urol Assoc J. 2008 Feb;2(1):16-21. doi: 10.5489/cuaj.520.
Related Links
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Finasteride monotherapy maintains stable lower urinary tract symptoms in men with benign prostatic hyperplasia following cessation of alpha blockers
Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride
Other Identifiers
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3-2020-0451
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
3-2020-0451
Identifier Type: -
Identifier Source: org_study_id
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