The OPtimal Dosage of Sildenafil in Ameliorating Urinary Symptoms in Patients with Lower Urinary Tract Symptoms Associated with Benign ProstatiC Hyperplasia

The OPtimal Dosage of Sildenafil in Ameliorating Urinary Symptoms in Patients with Lower Urinary Tract Symptoms Associated with Benign ProstatiC Hyperplasia: an Exploratory Multicenter, Double blind, Randomized, Placebo-Controlled Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001722

Enrollment

176

Registered

2015-12-09

Start date

2013-07-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Participants were instructed to ingest the study medication one in morning and two in evening daily for next 8 weeks. Experimental group 1 took sildenafil 25mg qd in evening

group 2 took sildenafil 25mg bid in morning and in evening

group 3 took sildenafil 50mg qd in evening

control group took placebo only

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
International prostate symptom score (I-PSS) total score	—

Secondary

Measure	Time frame
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]	—

Countries

Korea, Republic of

Contacts

Public ContactHyun Ho Han

National Health Insurance Service Ilsan Hospital

Outcome results