Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension

Area of Science:

• Urology
• Pharmacology

Background:

• Benign prostatic hyperplasia (BPH) frequently coexists with erectile dysfunction (ED).
• Lower urinary tract symptoms (LUTS) associated with BPH can impact sexual health and quality of life.

Purpose of the Study:

• To assess the efficacy and tolerability of daily 100-mg sildenafil for treating ED in men with BPH-associated LUTS.
• To evaluate the impact of sildenafil on erectile function, emotional well-being, and treatment satisfaction.

Main Methods:

• A 12-week, randomized, double-blind, placebo-controlled trial followed by an 8-week open-label extension.
• Participants were men aged 45+ with ED and moderate-to-severe LUTS, assessed using the International Index of Erectile Function (IIEF) and International Prostate Symptom Score (IPSS).

Main Results:

• Sildenafil significantly improved erectile function (IIEF scores), emotional well-being (SEAR), and treatment satisfaction (EDITS) compared to placebo (p < 0.0001).
• Erection hardness for penetration increased from ~50% to ~90%, and successful intercourse duration increased from ~25% to ~80% with sildenafil.
• Sildenafil was generally well-tolerated, with comparable long-term improvements in both initial sildenafil and placebo groups during the open-label phase.

Conclusions:

• Once-daily 100-mg sildenafil is an efficacious, effective, and well-tolerated treatment for men experiencing ED and BPH-associated LUTS.
• Sildenafil offers a valuable therapeutic option for improving sexual health in this patient population.