Early Real-World Clinical Outcomes and an Exploratory Cost-Impact Projection of Paclitaxel Drug-Coated Balloon Dilatation for Recurrent Male Urethral Stricture Disease: A Single-Centre Retrospective Study.

Objective This study aimed to evaluate changes in the International Prostate Symptom Score (IPSS) as the primary functional outcome following Optilume drug-coated balloon dilatation for recurrent male urethral stricture disease. Secondary outcomes included maximum urinary flow rate, post-void residual (PVR) volume, patient satisfaction, adverse events, and repeat intervention. An exploratory manufacturer-supplied cost-impact projection was also described separately. Materials and methods This retrospective single-centre study included 10 men treated during the early implementation of the Optilume drug-coated balloon (Urotronic, Inc., Plymouth, MN). Routinely recorded IPSS, maximum urinary flow rate (Qmax), PVR, satisfaction, complications, and repeat intervention data were reviewed. An exploratory cost-impact projection was generated using a manufacturer-supplied model and interpreted alongside economic guidance from the National Institute for Health and Care Excellence (NICE). This illustrative single-year projection was not a formal budget-impact analysis and was not based on audited, patient-level local cost data. Results The mean age of the cohort was 62.5 ± 6.5 years. All 10 patients (100%) had bulbar urethral strictures. Median IPSS decreased from 15.0 (interquartile range (IQR): 13.3-16.0) before treatment to 2.0 (IQR: 2.0-3.5) at follow-up (Wilcoxon signed-rank test, W = 1, p = 0.0039). Median Qmax increased from 7.5 (IQR: 5.3-9.0) mL/s to 18.8 (IQR: 15.4-19.8) mL/s (W = 0, p = 0.0020), and median PVR decreased from 211.5 (IQR: 150.0-239.0) mL to 20.0 (IQR: 11.3-26.8) mL (W = 0, p = 0.0020). Nine of 10 patients reported satisfaction with treatment. No urinary tract infection, urinary retention, haematuria requiring intervention, unplanned admission, or repeat stricture procedure was recorded at the latest follow-up. In the manufacturer-supplied model for 30 annual procedures, projected initial-procedure expenditure was £11,430 lower with Optilume after applying an assumed £1,500 reimbursement. Projected retreatment expenditure was approximately £17,252 lower. These figures were model-derived outputs and did not represent observed or audited local savings. Conclusions Drug-coated balloon dilatation was associated with early symptomatic and objective improvement in this selected cohort, although the uncontrolled study design does not allow conclusions regarding causation, comparative effectiveness, or durability. No major adverse events were documented, but the cohort was insufficient to assess uncommon complications. The exploratory cost-impact projection illustrates possible expenditure differences under the stated assumptions but does not demonstrate actual or realised savings.