One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture

2022 ◽  
Vol 3 (1) ◽  
Author(s):  
Jessica DeLong ◽  
Michael J. Ehlert ◽  
Bradley A. Erickson ◽  
Kaiser J. Robertson ◽  
Ramón Virasoro ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Erectile Function ◽  
Symptomatic Improvement ◽  
Additional Treatment ◽  
Adult Men ◽  
Urethral Strictures ◽  
Safety Endpoint ◽  
One Year ◽  
Drug Coated Balloon ◽  
Anatomic Success

Objective To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxel-coated balloon for the treatment of recurrent urethral strictures. Methods Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days post-procedure. Efficacy outcomes included symptomatic assessments, erectile function measured using the International Index of Erectile Function (IIEF), Qmax, and anatomic success. Results Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P < 0.001). Qmax improved from 6.9 mL/sec to 20.8 mL/sec (P < 0.001). There was no change in IIEF. Four subjects received additional treatment within 1 year. There were no treatment-related serious complications. Conclusions Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with the device was safe.

scholarly journals A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study

2020 ◽  
Vol 14 (6) ◽  
Author(s):  
Ramon Virasoro ◽  
Jessica DeLong ◽  
Rachel Mann ◽  
Rafael Estrella ◽  
Merycarla Pichardo ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Balloon Dilation ◽  
Serious Adverse Events ◽  
Urethral Strictures ◽  
Safety Endpoint ◽  
Study Population ◽  
Study Sites ◽  
One Year ◽  
Drug Coated Balloon ◽  
Anatomic Success

Introduction: We aimed to investigate the safety and preliminary efficacy of the OptilumeTM paclitaxel-coated balloon for the treatment of recurrent urethral stricture. Methods: Men with bulbar urethral strictures ≤2 cm with 1–4 prior endoscopic treatments were enrolled at four study sites after Ethics Committee approvals. All subjects were treated with mechanical balloon dilation or direct visualization internal urethrotomy prior to drug-coated balloon treatment. Patients were evaluated at 2–5 days, 14 days, three, six, and 12-months post-treatment. The primary safety endpoint was serious complications through 90 days post-procedure. The preliminary efficacy endpoint was anatomic success, defined as urethral lumen ≥14 Fr at 12 months. Results: A total of 53 subjects were enrolled and treated; 46 completed the 12-month followup. Forty-three percent of men had undergone >1 previous dilation; the mean for the overall study population was 1.7 prior dilations. There were no serious adverse events related to the treatment within 90 days. Anatomic success was achieved in 32/46 (70%; 95% confidence interval [CI] 54–82%) at 12 months. The 14 failures included seven cystoscopic recurrences, five retreatments, and two patients who exited the study early due to symptom recurrence. Conclusions: One-year data indicates the OptilumeTM paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

scholarly journals A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study

2020 ◽  
Vol 15 (2) ◽  
Author(s):  
Rachel A. Mann ◽  
Ramon Virasoro ◽  
Jessica M. DeLong ◽  
Rafael E. Estrella ◽  
Merycarla Pichardo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Urethral Stricture ◽  
Flow Rate ◽  
Erectile Function ◽  
Urine Volume ◽  
Urethral Stricture Disease ◽  
Residual Urine ◽  
Drug Coated Balloon

Introduction: Mechanical balloon dilation and direct visualization internal urethrotomy (DVIU) are the most widely used treatments for urethral stricture disease in the U.S., but recurrence rates are high, especially after re-treatment. This study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures. Methods: Men with recurrent bulbar strictures ≤2 cm with 1–4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 months post-treatment. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was ≥50% improvement in International Prostate Symptom Score (IPSS) at 24 months. Secondary outcomes included quality of life, erectile function, flow rate, and post-void residual urine volume. Results: A total of 53 subjects were enrolled and treated; 46 completed the 24-month followup. Forty-three percent of men had undergone >1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at two years. Success was achieved in 32/46 (70%), and baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function. Conclusions: Two-year data indicates the Optilume™ paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

scholarly journals PD22-06 ONE-YEAR SAFETY AND EFFICACY OUTCOMES ON A NOVEL DRUG COATED BALLOON (DCB) FOR URETHRAL STRICTURE DISEASE - THE ROBUST I STUDY

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Sean Elliott* ◽  
Ramon Virasoro ◽  
Jessica DeLong ◽  
Rafael Estrella ◽  
Merycarla Pichardo ◽  
...  
Keyword(s):  
Urethral Stricture ◽  
Safety And Efficacy ◽  
Urethral Stricture Disease ◽  
One Year ◽  
Novel Drug ◽  
Drug Coated Balloon

scholarly journals Buccal mucosal graft urethroplasty for radiation-induced urethral strictures: an evaluation using the extended Urethral Stricture Surgery Patient-Reported Outcome Measure (USS PROM)

2020 ◽  
Vol 38 (11) ◽  
pp. 2863-2872 ◽  
Author(s):  
Malte W. Vetterlein ◽  
◽  
Luis A. Kluth ◽  
Valentin Zumstein ◽  
Christian P. Meyer ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Urethral Stricture ◽  
Outcome Measure ◽  
Patient Reported Outcome ◽  
Patient Reported Outcome Measure ◽  
Urethral Strictures ◽  
Buccal Mucosal Graft ◽  
Surgery Patient ◽  
Patient Reported ◽  
Radiation Induced

Abstract Objectives To evaluate objective treatment success and subjective patient-reported outcomes in patients with radiation-induced urethral strictures undergoing single-stage urethroplasty. Patients and methods Monocentric study of patients who underwent single-stage ventral onlay buccal mucosal graft urethroplasty for a radiation-induced stricture between January 2009 and December 2016. Patients were characterized by descriptive analyses. Kaplan–Meier estimates were employed to plot recurrence-free survival. Recurrence was defined as any subsequent urethral instrumentation (dilation, urethrotomy, urethroplasty). Patient-reported functional outcomes were evaluated using the validated German extension of the Urethral Stricture Surgery Patient-Reported Outcome Measure (USS PROM). Results Overall, 47 patients were available for final analyses. Median age was 70 (IQR 65–74). Except for two, all patients had undergone pelvic radiation therapy for prostate cancer. Predominant modality was external beam radiation therapy in 70% of patients. Stricture recurrence rate was 33% at a median follow-up of 44 months (IQR 28–68). In 37 patients with available USS PROM data, mean six-item LUTS score was 7.2 (SD 4.3). Mean ICIQ sum score was 9.8 (SD 5.4). Overall, 53% of patients reported daily leaking and of all, 26% patients underwent subsequent artificial urinary sphincter implantation. Mean IIEF-EF score was 4.4 (SD 7.1), indicating severe erectile dysfunction. In 38 patients with data regarding the generic health status and treatment satisfaction, mean EQ-5D index score and EQ VAS score was 0.91 (SD 0.15) and 65 (SD 21), respectively. Overall, 71% of patients were satisfied with the outcome. Conclusion The success rate and functional outcome after BMGU for radiation-induced strictures were reasonable. However, compared to existing long-term data on non-irradiated patients, the outcome is impaired and patients should be counseled accordingly.

ROBUST III: Interim results of a randomized trial of the optilume drug coated balloon for anterior urethral strictures

2021 ◽  
Vol 79 ◽  
pp. S554
Author(s):  
R. Virasoro ◽  
J. Delong ◽  
K. Coutinho ◽  
K. Robertson ◽  
R. D’Anna ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Urethral Strictures ◽  
Drug Coated Balloon

scholarly journals Outcome of urethral strictures treated by endoscopic urethrotomy and urethroplasty

2014 ◽  
Vol 8 (1-2) ◽  
pp. 16 ◽  
Author(s):  
Javier Tinaut-Ranera ◽  
Miguel Angel Arrabal-Polo ◽  
Sergio Merino-Salas ◽  
Mercedes Nogueras-Ocaña ◽  
Victor Lopez-Leon ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Urethral Stricture ◽  
Previous Treatment ◽  
Urinary Flow ◽  
The Past ◽  
Urethral Strictures ◽  
High Surgical Risk ◽  
Endoscopic Urethrotomy ◽  
Male Patients ◽  
Maximum Urinary Flow

Introduction: We analyze the outcomes of patients with urethral stricture who underwent surgical treatment within the past 5 years.Methods: This is a retrospective study of male patients who underwent surgery for urethral stricture at our service from January 2008 to June 2012. We analyzed the comorbidities, type, length and location of the stricture and the surgical treatment outcome after endoscopic urethrotomy, urethroplasty or both.Results: In total, 45 patients with a mean age of 53.7 ± 16.7 years underwent surgical treatment for urethral stricture. Six months after surgery, 46.7% of the patients had a maximum urinary flow greater than 15 mL/s, whereas 87.3% of the patients exhibited no stricture by urethrography after the treatment. The success rate in the patients undergoing urethrotomy was 47.8% versus 86.4% in those undergoing urethroplasty (p = 0.01). Twenty percent of the patients in whom the initial urethrotomy had failed subsequently underwent urethroplasty, thereby increasing the treatment success.Conclusion: In most cases, the treatment of choice for urethral stricture should be urethroplasty. Previous treatment with urethrotomy does not appear to produce adverse effects that affect the outcome of a urethroplasty if urethrotomy failed, so urethrotomy may be indicated in patients with short strictures or in patients at high surgical risk.

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