Ramón Virasoro

Introduction: The goal of this study is to report the updated 3-year safety and efficacy outcomes of the intervention arm of the ROBUST III randomized controlled trial, comparing the Optilume® drug-coated balloon (DCB) with standard endoscopic management of recurrent male anterior urethral stricture. Methods: Eligible patients included adult men with recurrent anterior urethral stricture ≤3 cm in length and ≤12 Fr in diameter, International Prostate Symptom Score (IPSS) ≥11, and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary endpoints evaluated over the 3-year follow-up period included freedom from reintervention and alterations in IPSS, Qmax, and postvoid residual (PVR). The primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: Descriptive statistics of the intervention cohort have been published previously. The treatment arm maintained a high percentage of patients free from repeat intervention (71%), nearly equal to the 2-year results and three times higher than that observed in the control group at the 1-year mark. Clinically significant subgroups, including those with history of repeat endoscopic dilations (≥5 prior dilations) and longer stricture lengths (≥2 cm), did not demonstrate any significant differences in observed metrics, including IPSS score, Qmax, or PVR. In the crossover cohort of patients who experienced treatment failure with standard endoscopic management and opted for DCB treatment, the Kaplan–Meier curve for freedom from reintervention closely resembles that of the original DCB cohort. Treatment-related AEs were rare and generally self-limited (hematuria, dysuria, and urinary tract infection). Conclusion: The Optilume DCB continues to achieve significant improvements in symptoms and reintervention rates through 3 years posttreatment and represents a viable endoscopic alternative with durable results and a low-risk safety profile for the management of recurrent anterior urethral strictures ≤3 cm in length.

To report the 5-year study close-out results for the ROBUST I trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) for men with short, recurrent bulbar urethral strictures. Adult men with recurrent bulbar urethral strictures ≤ 2 cm long and lumen < 12 Fr were included in the study and treated with the Optilume DCB. Outcome measures included symptom questionnaires, maximum urinary flow rate (Qmax), post void residual (PVR), and freedom from repeat intervention. Functional success was defined as improvement in International Prostate Symptom Score (IPSS) of ≥ 50% without retreatment. Fifty-three men were enrolled and treated, and 31 subjects completed all follow-up. Functional success was achieved in 58% (25/43) patients at 5 years. Average IPSS improved from a mean of 25.2 at baseline to 7.2 at 5 years (P < .001). Freedom from repeat intervention was maintained through 5 years at 71.7% estimated by Kaplan-Meier. Qmax improved from 5.0 mL/s at baseline to 19.9 (P < .01) and average PVR was reduced from 141.4 mL to 59.5 mL (P < .01) at 5 years follow up. Erectile function remained unaffected. There were no serious treatment-related adverse events. In this challenging cohort of men with failed prior endoscopic treatment, the Optilume DCB shows sustained improvement in subjective and objective voiding parameters at 5 years. Optilume is a safe and effective treatment option for appropriately selected men with recurrent bulbar urethral stricture who wish to avoid urethroplasty. Results are in line with the ROBUST III randomized controlled trial that will continue follow-up through 5 years.

Introduction: Endoscopic management of male anterior urethral stricture disease is common; however, repeat treatment is associated with high recurrence rates. Here, we report the 3-year results of the ROBUST I trial, which evaluated the safety and efficacy of the Optilume^® drug coated balloon (DCB) in men with recurrent urethral strictures. Methods: Adult men with recurrent bulbar urethral strictures ≤ 2 cm in length and 1– 4 prior endoscopic interventions were treated with the Optilume DCB. Functional success was defined as ≥ 50% reduction in International Prostate Symptom Score (IPSS) without need for retreatment. Other outcomes included quality of life, maximum flow rate, post-void residual urine volume, erectile function, and freedom from repeat intervention. Results: Of the 53 enrolled and treated men, 33 completed the 3-year visit, with 10 patients experiencing clinical failures at previous visits, giving a total of 43 subjects evaluable for the functional success endpoint. Functional success was achieved in 67% (29/43) and freedom from retreatment in 77% (33/43). Average IPSS improved from 25.2 at baseline to 5.5 at 3 years (p< 0.0001). Significant improvements were observed in quality of life, flow rate, and post-void residual urine volume. Erectile function was not affected by treatment. Device-related adverse events were mild or moderate in nature and resolved quickly after onset. There were no serious treatment-related adverse events. Conclusion: Symptomatic improvement after treatment with the Optilume DCB was maintained through 3 years in a population highly susceptible to recurrent urethral stricture disease. This minimally invasive therapy is safe with no negative impact on sexual function.

Purpose:The Optilume® Drug Coated Balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery ...

Purpose Adult acquired buried penis (AABP) can present with concomitant Lichen Sclerosus (LS), a chronic dermatosis that may affect surgical outcomes. Our aim was to evaluate outcomes of patients undergoing AABP repair with and without LS. Methods A retrospective cohort study was performed for AABP repair patients at a single institution from 1/1991 to 12/2017. Patient characteristics and surgical and peri-operative outcomes, including success, erectile function, and complications, were collected. Results Sixty-seven AABP patients with mean follow-up of 16.1 ± 20.4 months were identified. Overall surgical success was 91%. Overall surgical complication rate was 50.7% (23.9% Clavien-Dindo ≥ 3). Forty-two (62.7%) patients had concomitant LS. A higher proportion of patients with LS required a STSG (90% vs 60%, p = 0.005). There was no difference in surgical success (90.5% vs 92.0%, p = 0.999), overall complication rate (57.1% vs 40.0%, p = 0.212), Clavien-Dindo ≥ 3 complications (23.8% vs 24.0%, p = 0.999) or early complications (35.7% vs 32.0%, p = 0.797) between patients with and without LS, respectively. However, a higher proportion of patients with LS experienced late complications (33.3% vs 8.0%, p = 0.020), which were mainly related to wound healing. Satisfaction with erectile function was higher among patients with LS (59.5% vs 320%, p = 0.043). Conclusion AABP patients with LS behave somewhat differently than their non LS counterparts. They are more likely to require skin graft during surgical treatment. Though surgical success and complications are similar, they do experience a higher rate of late complications from impaired wound healing. Work on improving wound healing in this population should be considered.

To determine predictors for surgical complications and assess patient satisfaction after surgical treatment of Adult-Acquired Buried Penis (AABP).

To present current evidence supporting the vessel sparing technique to reconstruct bulbar urethral strictures via primary anastomosis.