A cross-over study of the effects of terazosin or tamsulosin on the efficacy and sexual function of lower urinary tract symptoms in patients with benign prostatic hyperplasia

Not Applicable

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0004914
• Lead Sponsor: lsan Univeristy Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 April 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

Visit 1
Subjects must meet all of the following criteria at Visit 1.
  1) Men 45 and older
  2) Patients diagnosed with BPH
  3) Voluntary consent for participation in this clinical trial

Visit 2
After screening, after run-in period, all the following criteria should be met. (If you have already washed out for more than two weeks prior to screening, you can run Visit 1 and Visit 2 simultaneously without a run-in period.)
1) IPSS total score = 13
2) Minimum urination rate = 125ml and 4ml / sec <maximum rate = 15ml / sec
3) Patients with postvoid residual volume (PVR) <150 m

Exclusion Criteria

Any one of the following conditions will not be allowed to participate in this clinical trial.
1) Persons with hypersensitivity to the investigational drug and components
2) Patients with the following history
A. Other prostate diseases, including prostatitis and prostate cancer
B. Prostate Related Surgery and / or Other Invasive Procedures
C. Surgery that may affect lower urinary tract symptoms such as urethral incisions
D. Acute urinary tracts requiring intubation within 12 weeks prior to screening
E. Myocardial infarction and incomplete angina within 6 months prior to screening
F. Three or more urinary tract infections within 12 months prior to screening
3) Those who have confirmed the following comorbidities
A. Other diseases that may affect lower urinary tract symptoms (e.g., neurogenic bladder, urethral or bladder neck stenosis, severe bladder diverticula, etc.)
B. orthostatic hypotension
C. Active Urinary Tract Infection
D. Uncontrolled hypertension (systolic blood pressure> 180 mmHg or diastolic blood pressure> 100 mmHg)
E. Uncontrolled Diabetes (HbA1c> 9.0)
4) Serum prostate specific antigen (PSA) = 4,0 ng / ml (However, even if the PSA is 4.0ng / ml or more, if prostate biopsy is confirmed to be not prostate cancer, it is possible to participate. Test results within the past year can be used.)
5) Those who received alpha blockers, anti-muscarinic agents, PDE5 inhibitors, or beta-3 antagonists within 2 weeks prior to screening (but can participate if visitation can be stopped after visit 1, and wash- over 2 weeks before screening) If it is out, it can be registered immediately without run-in period.)
6) Those who received 5 alpha reductase inhibitor within 12 weeks (Finasteride) or 24 weeks (Dutastaeride) before screening
7) Others who are inappropriate to participate in this study as judged by other researchers.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total International Prostate Symptom Score (Total IPSS) Change

Secondary Outcome Measures

Name	Time	Method
Change in IPSS voiding symptom score (Sum of Q1, Q3, Q5 and Q6);Change in IPSS storage symptom score (Sum of Q2, Q4 and Q7);Change in IPSS QoL (Q8);Change in maximum urination rate(Qmax);Change in postvoid residual volume (PVR);Change in MSHQ score