* To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns. * To determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction * To assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use * To assess if microalbuminuria predicts flow-mediated dilation (FMD) response * To measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)
60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly blinded. Subjects will be followed by IIEF, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry. Study time-points are at baseline, 6 and 12 weeks. Study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
24
Sildenafil 100mg daily for 12 weeks
St. Joseph's Health Care London/Urology Clinic
London, Ontario, Canada
Determine if PDE5 use over 12 week period in ED diabetic men improves endothelial function as measured by FMD of the brachial artery, as compared to placebo; Assess treatment response to sildenafil over a 12 week period of exposure compared to placebo.
Time frame: 12 weeks
IIEF Questionnaire & diary response;Blood pressure and microalbuminuria; Side effects
Time frame: 12 weeks
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