Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture. Materials and Methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr 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 efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection). Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

Prospective Trial of Water Vapor Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia in Subjects with a Large Prostate: 6- and 12-month Outcomes.

Background: Current guidelines recommend Rezum water vapor thermal therapy for the treatment of benign prostatic hyperplasia (BPH) for prostate glands ranging in volume from 30 to 80 cm3. Few prospective studies have specifically evaluated the use of Rezum for larger prostates. Objective: To evaluate the safety and efficacy of water vapor thermal therapy in patients with a prostate gland >80 cm3 and ≤150 cm3. Design setting and participants: In this prospective, single-arm study at seven centers in the USA, subjects were males aged >50 yr with symptomatic BPH and prostate volume of >80 cm3 and ≤150 cm3. Intervention: Rezum was used to deliver sterile water vapor via a transurethral approach to ablate targeted areas of prostate tissue. Outcome measurements and statistical analysis: The primary efficacy outcome was response to therapy, defined on a per-patient basis as a ≥30% improvement in International Prostate Symptom Score (IPSS) from baseline to 6 mo. The primary safety outcome was a composite of serious device-related safety events. Secondary outcomes included catheterization for device-related retention. IPSS outcomes over time were analyzed via generalized estimating equations. Results and limitations: Among 47 eligible patients, prostate volume ranged from 80.8 to 148.1 cm3. All patients completed 6-mo follow-up, and 40/47completed 12-mo follow-up. At 6 mo, 83% were treatment responders according to the primary efficacy endpoint. The mean IPSS improvement at 6 mo was 11.9 ± 7.5 points, reflecting significant improvement. The primary safety outcome was met, with no occurrence of device-related composite safety events. The study is limited by the nonrandomized design and early termination, unrelated to safety or effectiveness. Conclusions: Our results are consistent with previous findings for prostate glands of up to 80 cm3, and indicate the safety and efficacy of Rezum for BPH in patients with a larger prostate. Patient summary: Rezum therapy, in which water vapor is used to treat targeted areas of the prostate, is currently recommended for patients with benign enlargement of the prostate and a prostate size of up to 80 cm3. We found that this treatment was also effective and safe in patients with a larger prostate of 80-150 cm3.

Transurethral Vapor Ablation in Patients with Intermediate-Risk Localized Prostate Cancer.

Purpose: We report results of a prospective, multicenter single-arm study of transurethral vapor ablation (TUVA) of prostate tissue in patients with unilateral, intermediate-risk, localized prostate cancer (PCa). Materials and Methods: Men ≥45 years of age with biopsy-confirmed unilateral Gleason grade group 2 (GGG2) adenocarcinoma of the prostate, prostate volume of 20-80 cc, and prostate-specific antigen (PSA) ≤15 ng/mL were enrolled. Cystoscopy and transrectal ultrasound (TRUS) guidance were used to deliver ∼103°C water vapor to prostate zones for unilateral hemigland ablation, including destruction of cancers detected by multiparametric MRI (mpMRI) and confirmed by biopsy. The primary outcomes were device-related serious adverse events (SAEs). At 7 days and 6 months postprocedure, the ablation extent was assessed by mpMRI; MRI/TRUS fusion biopsies were completed at 6 months. Quality of life (QOL) was assessed with validated questionnaires. Results: All subjects underwent a single hemigland TUVA procedure. No SAEs occurred. Grade 2 procedure-related AEs included transient urinary retention (n = 4) and erectile (n = 1) or ejaculatory dysfunction (n = 1). At 7 days, mpMRI revealed complete ablation of 14/17 (82%) visible lesions. At 6 months, biopsies showed no Gleason pattern ≥4 or ≥GGG2 cancer on the treated side of prostates in 13/15 (87%) subjects. Ten of 15 (67%) subjects were biopsy negative. Of the 5 biopsy-negative subjects, 2 had one core each of 3 + 4 disease and 3 had one core each of 3 + 3 disease with ≤5% involvement. Median prostate volume was reduced by 40.7% and PSA by 58%. Extensive QOL assessments showed, on average, no appreciable negative effects of treatment. Conclusions: Initial evidence suggests that TUVA is safe in men with intermediate-risk PCa. Preliminary results demonstrate the absence of ≥GGG2 disease on the treated side in 87% of men and a favorable QOL profile.

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures.

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 to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. MATERIALS AND METHODS: Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications. RESULTS: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria. CONCLUSIONS: The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezum™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSIONS: Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.

The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) and accompanying lower urinary tract symptoms (LUTS) sits in the top ten prominent and costly disease conditions in men over 50 years of age. In the United States it is the most common diagnosis made by urologists for men 45 to 74 years of age. Twenty percent of the population will reach 65 years of age or older by 2030, and those over 85 years will represent the fastest growing segment of our population. The prevalence of symptomatic BPH increases proportionally with the aging population. It is estimated that BPH now affects 6% of the male population worldwide. Moreover, in Canada, the estimated BPH prevalence is more than 1 million men aged 50 years and older. Among the various surgical treatments, Rezum water vapor thermal therapy has been developed as a unique, rapid and reproducible minimally invasive surgical treatment exhibiting safe and early effective relief of LUTS/BPH. The targeted prostate tissue ablation is amenable to all zones of the prostate including intravesical median lobes. We present our experiences with this technique, which can be quickly performed under local anesthesia in an office setting.

Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

PURPOSE: We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezum® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. RESULTS: Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported. CONCLUSIONS: Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study.

INTRODUCTION: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. AIM: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. METHODS: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2:1 between Rezum System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. MAIN OUTCOME MEASURES: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. RESULTS: No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P = .0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P < .0001). CONCLUSION: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.

Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezum® System and control. Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary end point compared International Prostate Symptom Score reduction at 3 months. Treatment subjects were followed for 12 months. RESULTS: There were 197 men randomized (active 136, control 61). Thermal therapy and control International Prostate Symptom Score was reduced by 11.2 ± 7.6 and 4.3 ± 6.9 respectively (p <0.0001). Treatment subject baseline International Prostate Symptom Score of 22 decreased at 2 weeks (18.6, p=0.0006) and by 50% or greater at 3, 6 and 12 months, p <0.0001. The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p <0.0001). No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly. CONCLUSIONS: Convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia symptoms and preserves erectile and ejaculatory function. Treatment can be delivered in an office or hospital setting using oral pain medication and is applicable to all prostate zones including the median lobe.