The OPtimal Dosage of Sildenafil in Ameliorating Urinary Symptoms in Patients with Lower Urinary Tract Symptoms Associated with Benign ProstatiC Hyperplasia
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0001722
- Lead Sponsor
- ational Health Insurance Service Ilsan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 176
Men were enrolled in the study if they were 45 years or older, had a clinical diagnosis of LUTS due to BPH on visit 1 [I-PSS = 8 points; uroflowmetry Qmax = 4 mL/s and = 15 mL/s, voided volume = 150 mL (recorded within last 4 weeks); prostate volume = 20mL (measured within last 3 months)]
* LUTS = Lower urinary tract symptoms; BPH = benign prostatic hyperplasia; ED = erectile dysfuction.
Men were excluded from study if they had PVR = 200mL (measured within last 4 weeks); serum prostate specific antigen (PSA) = 4 ng/mL; any medical intervention for BPH, ED or overactive bladder within last 2 weeks; any use of finasteride within last 3 months or dutasteride within last 6 months; any use of alpha-blocker within last 2 weeks; history of poorly controlled diabetes mellitus (HbA1c = 9%), hypertension or orthostatic hypotension; history of renal failure (Cr clearance = 30mL/min or hepatic dysfunction (AST or ALT = twice of normal limit); history of urinary retention or urinary stone within last 30 days; history of medical conditions except BPH that may affect LUT (urethral stricture, neurogenic bladder, lower urinary tract malignancy or infectious disease); history of endoscopic/surgical intervention for LUTS/BPH; history of pelvic radiation or diagnosis of interstitial cystitis; history of cardiovascular accidents (= NYHA class II) within last 6 months; history of any cerebrovascular accidents within last 6 months; history of diabetic retinitis, vision loss due to non-arteritic anterior ischemic optic neuropathy; diagnosis of active peptic ulcer. Patients were also excluded if they are not medically fit to undergo the trial, judged by their medical examiner.
* LUTS = Lower urinary tract symptoms; BPH = benign prostatic hyperplasia; ED = erectile dysfuction.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International prostate symptom score (I-PSS) total score
- Secondary Outcome Measures
Name Time Method International prostate symptom score (I-PSS) total score;International prostate symptom score (I-PSS) sub-score [storage domain, voiding domain, nocturia and quality of life score];Uroflowmetry Qmax and PVR;Safety [All observed or volunteered adverse effects (AEs)];erectile function [assessed via International Index of Erectile Function (IIEF-15) questionnaire]