Georgi Tosev

Purpose Recurrent urethral stricture following urethroplasty remains a clinical challenge. This study aimed to evaluate the efficacy and safety of the Optilume® paclitaxel drug-coated balloon (DCB) in patients with recurrent anterior urethral strictures after prior urethroplasty. Methods This multicentre retrospective study included 25 male patients (mean age 60.6 ± 18.25 years) treated at two German centres between January 2021 and October 2025. The Optilume® DCB (30 Fr, 5 cm) was deployed under cystoscopic guidance and inflated to 10 atm for 7 min. The primary endpoint was functional success, defined as absence of obstructive symptoms and freedom from re-intervention at 12 months. Secondary endpoints included changes in International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QoL), and post-void residual (PVR) urine. Results Of the 25 treated patients, 23 had completed 12-month follow-up and were evaluable for the primary endpoint; functional success was achieved in 19 of these 23 patients (83%). Kaplan–Meier analysis demonstrated a 1-year freedom-from-re-intervention rate of 75.4% (95% CI 60.0–94.7%). Mean IPSS improved from 23.6 ± 7.25 to 16.8 ± 9.84 (p = 0.001; Cohen’s d = 0.73), while IPSS-QoL improved from 4.6 ± 0.92 to 3.0 ± 1.85 (p < 0.001; Cohen’s d = 0.79). PVR showed a non-significant reduction (93.8 to 71.0 mL; p = 0.137). No major complications or cases of urinary incontinence were observed. Median follow-up was 13.4 months (IQR 9.9–20.6). Conclusion The Optilume® DCB represents an effective and minimally invasive salvage treatment for recurrent anterior urethral stricture after urethroplasty, providing durable functional improvement and low retreatment rates at 12 months.

Background/Objectives: Penile urethral stricture is a therapeutically challenging condition that significantly impacts quality of life and is often managed initially with urethral dilation or internal urethrotomy. However, both techniques are associated with high recurrence rates, limited long-term efficacy, and potential adverse effects, particularly in the penile urethra. Urethroplasty remains the gold standard but is invasive and not suitable for all patients. Optilume, a paclitaxel-coated balloon, combines mechanical dilation with localized drug delivery to reduce recurrence rates and the need for re-intervention. This study evaluated its effectiveness in patients with penile urethral strictures. Methods: A retrospective, multicenter study was conducted at two German clinics. Eight male patients (mean age 59) with symptomatic penile urethral strictures underwent Optilume treatment. Symptom severity was assessed using the International Prostate Symptom Score (IPSS) and quality of life (QoL) scores before and after treatment. The primary endpoint was symptom improvement, while the secondary endpoint was the need for reintervention. Patients were followed for a median of 16.5 months. Statistical analyses included Wilcoxon signed-rank and Mann–Whitney U tests. Results: The median IPSS improved from 25.5 to 5.0 and QoL scores from 4.5 to 1.0 after treatment (p < 0.01 for both). No patients required reintervention during follow-up. The subgroup analysis showed slightly better outcomes in patients without prior interventions, although differences were not statistically significant. The stricture length did not correlate with treatment response. Conclusions: Optilume significantly reduces urinary symptoms and improves QoL in penile urethral strictures, and the absence of re-interventions during follow-up underscores its durable mid-term success. It offers a minimally invasive alternative to urethroplasty, particularly for patients seeking symptom relief with a shorter recovery time and no hospital stay or general anesthesia. These preliminary findings suggest that Optilume may be a promising minimally invasive option for selected patients. Larger, controlled studies are warranted to validate these results and refine patient selection criteria.

Background: Renal cell carcinoma (RCC) is among the most lethal urologic malignancies once metastatic. Current treatment approaches for metastatic RCC (mRCC) involve immune checkpoint inhibitors (ICIs) that target the PD-L1/PD-1 axis. High PD-L1 expression in tumor tissue has been identified as a negative prognostic factor in RCC. However, the role of PD-L1 as a liquid biomarker has not yet been fully explored. Herein, we analyze urine levels of PD-L1 in mRCC patients before and after either ICI therapy or surgical intervention, as well as in a series of patients with treatment-naïve RCC. Patients and Methods: The mid-stream urine of patients with mRCC (n = 4) or treatment-naïve RCC, i.e., prior to surgery from two centers (cohort I, n = 49: cohort II, n = 29) was analyzed for PD-L1 by ELISA. The results from cohort I were compared to a control group consisting of patients treated for non-malignant urologic diseases (n = 31). In the mRCC group, urine PD-L1 levels were measured before and after tumor nephrectomy (n = 1) or before and after ICI therapy (n = 3). Exosomal PD-L1 in the urine was analyzed in selected patients by immunoblotting. Results: A strong decrease in urine PD-L1 levels was found after tumor nephrectomy or following systemic treatment with ICIs. In patients with treatment-naïve RCC (cohort I), urine PD-L1 levels were significantly elevated in the RCC group in comparison to the control group (median 59 pg/mL vs. 25.7 pg/mL, p = 0.011). PD-L1 urine levels were found to be elevated, in particular, in low-grade RCCs in cohorts I and II. Exosomal PD-L1 was detected in the urine of a subset of patients. Conclusion: In this proof-of-concept study, we show that PD-L1 can be detected in the urine of RCC patients. Urine PD-L1 levels were found to correlate with the treatment response in mRCC patients and were significantly elevated in treatment-naïve RCC patients.

There are currently five programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors approved for the treatment of locally advanced or metastatic urothelial carcinoma (UC) of the bladder. For platinum-ineligible patients, testing of tumor specimens for PD-L1 expression is required. However, scoring of PD-L1 immunohistochemistry is complex due to different antibodies used, the requirement to score expression in different cellular compartments and intratumoral heterogeneity. It can also be difficult to obtain and test longitudinal tumor samples, which would be desirable to monitor treatment responses and tumor evolution under treatment-induced selective pressure. In the present proof-of concept study, we provide evidence that PD-L1 can be detected in the urine of patients with non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). Urine PD-L1 levels were significantly higher in NMIBC and MIBC patients when compared to patients with various non-malignant urological diseases. Further prospective and independent studies are required to assess the value of PD-L1 in the urine as a novel biomarker with potential for the early detection, prediction and therapeutic monitoring of patients with UC of the bladder.