Bladder neck sclerosis (BNS) occurs in approximately 1–5% of patients after endoscopic anatomical enucleation of the prostate (AEEP) and in 5–15% after robot-assisted radical prostatectomy (RARP), with recurrence rates of up to 30–50% following bladder neck incision or resection. BNS after AEEP is primarily associated with fibrosis induced by thermal injury, whereas post-RARP BNS is mainly driven by ischemia and anastomotic tension at the vesicourethral anastomosis, potentially affecting treatment response. Drug-coated balloon technology combines mechanical dilation with local paclitaxel delivery and has demonstrated recurrence-free rates of 70–80% at 12 months in anterior urethral strictures. The aim of this study was to evaluate the short-term efficacy and safety of primary paclitaxel-coated balloon dilation for BNS after AEEP or RARP and to explore potential differences between these two clinical settings.

We retrospectively analyzed a consecutive series of 24 patients treated with direct Optilume dilation for BNS between January 2024 and January 2025. Patients were stratified according to the index procedure (12 AEEP vs 12 RARP). All patients underwent primary balloon dilation without prior bladder neck incision or resection. The primary endpoints were improvement in maximum urinary flow rate (Qmax) and reduction of post-void residual (PVR). Secondary endpoints included changes in the International Prostate Symptom Score (IPSS) and IPSS quality of life (IPSS-QoL) and recurrence-free rate at 12-month follow-up.

At 12 months, clinically meaningful improvements in urinary flow and symptoms were observed in both groups. Qmax increased after AEEP [median 7.1 ml/s (IQR 5.2-9) to 16.4 (13.1-17), p < 0.001] and after RARP [6.4 (4.7-8) to 14.8 (12-15.5), p < 0.001]. PVR decreased after AEEP [55ml (43-65) to 25 (15-30), p < 0.001] and after RARP [58 (40-68) to 18 (15-23), p < 0.001]. IPSS and IPSS-QoL improved after both AEEP [29 (22-32) + 4 (3-5) to 10 (8-15) +2 (0-3), p < 0.001] and after RARP [31 (27-33) +4 (3-5) to 12 (9-14) +2 (1-3), p < 0.001]. Overall, 79% of patients remained recurrence-free at 12 months, with recurrence-free rates of 83% after AEEP and 75% after RARP (p=0.05). No Clavien–Dindo grade ≥ II complications, de-novo urinary incontinence, or paclitaxel-related adverse events were observed.

Paclitaxel-coated balloon dilation resulted in clinically meaningful functional and symptomatic improvement after both AEEP and RARP. Recurrence-free rates were favourable compared with standard endoscopic series, with a numerical trend toward higher durability after AEEP, possibly reflecting different stenosis mechanisms.

Primary paclitaxel-coated balloon dilation appears to be a safe and effective minimally invasive treatment for BNS after both AEEP and RARP, providing meaningful short-term functional and symptomatic improvement. These outcomes were achieved using direct balloon dilation as a first line treatment, supporting its feasibility as a standalone endoscopic approach, with a numerical trend toward greater durability after AEEP. Larger prospective studies with longer follow-up are warranted.

Continence 19S (2026) 102713
DOI: 10.1016/j.cont.2026.102713