Disappointing initial results with transurethral alprostadil for erectile dysfunction in a urology practice setting

Area of Science:

• Urology
• Andrology
• Pharmacology

Background:

• Erectile dysfunction (ED) affects a significant number of men, impacting quality of life.
• Intraurethral alprostadil, delivered via the Medicated Urethral System for Erection (MUSE), is a treatment option for ED.
• Previous studies have indicated the efficacy of MUSE, but real-world, in-office performance requires further evaluation.

Purpose of the Study:

• To evaluate the efficacy and safety of intraurethral alprostadil using MUSE in men with a history of ED.
• To assess the impact of MUSE on blood pressure during in-office monitoring.
• To compare the in-office efficacy of MUSE with results from a placebo-controlled pivotal study.

Main Methods:

• 115 men with ED underwent in-office MUSE testing following manufacturer guidelines.
• Patients rated erection rigidity and discomfort at 15-minute intervals.
• Blood pressure was monitored before and after administration; patients were followed up via telephone 2-3 months post-treatment.

Main Results:

• Mean rigidity scores improved slightly but did not significantly differ between dosages, with only 30% achieving intercourse-suitable erections at 30 minutes with 1,000 mcg.
• Significant decreases in blood pressure were observed, with 41.2% experiencing orthostatic hypotension.
• Adverse events included penile pain, discomfort, burning, dizziness, and chest pain; only 18.6% continued MUSE use at home.

Conclusions:

• In-office MUSE administration demonstrated limited efficacy in achieving sufficient erections for intercourse compared to pivotal studies.
• Treatment was associated with significant discomfort, pain, and adverse hemodynamic effects, including orthostatic hypotension.
• High discontinuation rates at home were attributed to inadequate efficacy, side effects, and cost, with over 80% ceasing treatment.