Real-World Outcomes and Learning Curve for Drug-Coated Balloon BPH Therapy

Rahul Mehan, MD, compares his roughly 2 years of practice experience with the PINNACLE trial's (NCT04131907) randomized, sham-controlled results. Trial patients started with a baseline International Prostate Symptom Score (IPSS) around 23 and improved about 11.5 points at 1 year, with Qmax gains of roughly 125%; Mehan reports consistent results in his own patients, with no retreatments to date and no cases of erectile or ejaculatory dysfunction. He describes the anatomic profile that predicts success—prostates in the 30- to 70-gram range with predominantly lateral lobe obstruction and a clear obstructive urethra—and explains why he avoids the procedure in patients with prominent median lobes, high-riding bladder necks, or significant bladder dysfunction.

On the learning curve, Mehan says the technical skills are familiar to any urologist comfortable with office-based cystoscopy; the real learning is in patient selection, balloon sizing based on prostatic urethral length, and recognizing a well-executed anterior commissurotomy. He contrasts the recovery with transurethral resection of the prostate and waterjet therapy: Because tissue isn't resected or ablated, patients avoid the prolonged healing of more invasive procedures, though he counsels them to expect hematuria, dysuria, and irritable symptoms for several weeks as the paclitaxel coating does its work.

He also cites 3-year PINNACLE data—IPSS improvement sustained near 13 points and Qmax nearly doubled from baseline, with only 6% of patients going on to another surgical procedure—and details the counseling he gives around hematuria (reported in approximately 40% of PINNACLE patients, mostly mild to moderate) and the contraception guidance tied to paclitaxel exposure. In his own practice, he says, careful post-procedure protocols have kept the safety profile favorable, with no transfusions to date.

In the next episode, Mehan discusses where TURP and HoLEP still outperform office-based options, offers practical advice for urologists just starting to adopt drug-coated balloon dilation, and looks ahead to emerging minimally invasive technologies.