Editorial Comment: Safety and Efficacy of Vibegron in Men With Overactive Bladder Symptoms on Pharmacotherapy for Benign Prostatic Hyperplasia: Results From the 28-Week Open-Label COURAGE Extension Trial Completing the 52-Week Phase 3 Evaluation

The current study took a group of men previously enrolled in the COURAGE trial and had them continue vibegron 75 mg daily (both original arms were placed on active treatment—the original vibegron group as well as those originally on placebo) and monitored them for safety as well as efficacy outcomes for an additional 28 weeks.1 Of note, all these men were on a stable dose of medication for benign prostatic hyperplasia (BPH). In addition, this was an industry-funded study. The findings in a nutshell are that at 52 weeks there were no additional safety concerns beyond those noted in the original trial and efficacy was generally maintained. While time will tell if there are any additional safety concerns that appear in the future, a 52-week observation period is quite reassuring. This study reinforces the important takeaway of the original COURAGE trial—men being managed pharmacologically for BPH who have residual overactive bladder symptoms can have improvement in those symptoms without significant safety concerns when the beta-3 agonist vibegron is given. The continued efficacy and safety is reassuring. However, the question must be asked that if it takes 2 or perhaps 3 medications to provide symptom relief might the patient benefit more from surgical intervention. With the current range of minimally invasive BPH treatments a one-time intervention might avoid the need for medication completely. This is where shared decision making between the patient and the clinician comes in. Weighing the pros and cons of each treatment option an appropriate therapy can be determined. We are fortunate to have such a broad range of both medical and surgical options such that multiple choices are available and treatment can be tailored to the specific patient.