A Phase 3 interventional study of alpha-blocker or 5-ARI withdrawal and Maintenance of alpha-blocker and 5-ARI in Prostatic Hyperplasia, Prostate Hyperplasia and Prostatic Hypertrophy, sponsored by Gangnam Severance Hospital. Status unknown at 1 site in Korea, Republic of. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by Gangnam Severance Hospital · Phase 3, Interventional, and Treatment
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.
Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α 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).
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 300 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
receives 5-ARI monotherapy
Drug: alpha-blocker or 5-ARI withdrawal
receives alpha-blocker monotherapy
Drug: alpha-blocker or 5-ARI withdrawal
receives alpha-blocker and 5-ARI
Drug: Maintenance of alpha-blocker and 5-ARI
Withdrawal of either alpha-blocker or 5-ARI
Also known as: alpha-blocker withdrawal, 5-ARI withdrawal
Maintenance of alpha-blocker and 5-ARI
Change in International Prostate Symptom Score (IPSS) score from baseline
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, 12, and 18. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Month 18 is the primary timepoint and earlier timepoints are considered secondary. Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 18 months
Number of adverse events
Adverse events includes; dizziness, headache, pounding heartbeat, weakness. decreased sexual desire, impotence, ejaculatory disorder, gynecomastia, depression, and anxiety.
Time frame: 3, 6, 12, 18 months
Change in International Prostate Symptom Score (IPSS) from baseline
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, and 12. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 3, 6, 12 months
Change in Overactive bladder symptom score (OABSS) from baseline
The OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score. The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). OABSS is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 3, 6, 12, 18 months
Change in EuroQol five dimension scale (EQ-5D) score from baseline
The EuroQol five dimension descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ-5D is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 3, 6, 12, 18 months
Change in Qmax from baseline
The measurement of maximum urinary flow rate (Qmax) is widely used in the assessment of men complaining of lower urinary tract symptoms. Qmax is performed at screening and each time-point of month 3, 12, and 18. Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 3, 12, 18 months
Change in prostate volume from baseline
The measurement of prostate volume is performed at screening and at month 18. Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 18 months
Change in prostate-specific antigen (PSA) level from baseline
The measurement of prostate-specific antigen (PSA) level is performed at screening and at month 18. Change from baseline defined as difference between post-baseline value and baseline value.
Time frame: 18 months
Plan to share: No
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Gangnam Severance Hospital