One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume ® Drug-Coated Balloon for Anterior Urethral Strictures
2021; Lippincott Williams & Wilkins; Volume: 207; Issue: 4 Linguagem: Inglês
10.1097/ju.0000000000002346
ISSN1527-3792
AutoresSean P. Elliott, Karl Coutinho, Kaiser J. Robertson, Richard D’Anna, Kent Chevli, Serge Carrier, Mélanie Aubé-Peterkin, Christopher H. Cantrill, Michael Ehlert, Alexis E. Te, Jeffrey Dann, Jessica DeLong, Steven B. Brandes, Judith C. Hagedorn, Richard Levin, Amy Schlaifer, Euclid DeSouza, David S. DiMarco, Bradley A. Erickson, Richard Di Natale, Douglas A. Husmann, Allen F. Morey, Carl A. Olsson, Ramón Virasoro,
Tópico(s)Urinary and Genital Oncology Studies
ResumoOpen AccessJournal of UrologyAdult Urology1 Apr 2022One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral StricturesThis article is commented on by the following:Editorial CommentEditorial Comment Sean P. Elliott, Karl Coutinho, Kaiser J. Robertson, Richard D'Anna, Kent Chevli, Serge Carrier, Melanie Aube-Peterkin, Christopher H. Cantrill, Michael J. Ehlert, Alexis E. Te, Jeffrey Dann, Jessica M. DeLong, Steven B. Brandes, Judith C. Hagedorn, Richard Levin, Amy Schlaifer, Euclid DeSouza, David DiMarco, Brad A. Erickson, Richard Natale, Douglas A. Husmann, Allen Morey, Carl Olsson, and Ramón Virasoro Sean P. ElliottSean P. Elliott *Correspondence: Department of Urology, University of Minnesota, 420 Delaware St. SE, MMC 394Minneapolis, Minnesota 55405 telephone: 612-625-7486; FAX: 612-626-0428; E-mail Address: [email protected] University of Minnesota, Minneapolis, Minnesota , Karl CoutinhoKarl Coutinho New Jersey Urology LLC, Millburn, New Jersey , Kaiser J. RobertsonKaiser J. Robertson Chesapeake Urology, Hanover, Maryland , Richard D'AnnaRichard D'Anna Arkansas Urology, Little Rock, Arkansas , Kent ChevliKent Chevli Western New York Urology Associates, Cheektowaga, New York , Serge CarrierSerge Carrier McGill University Health Center, Montreal, Quebec, Canada , Melanie Aube-PeterkinMelanie Aube-Peterkin McGill University Health Center, Montreal, Quebec, Canada , Christopher H. CantrillChristopher H. Cantrill Urology San Antonio, San Antonio, Texas , Michael J. EhlertMichael J. Ehlert Metro Urology, a division of Minnesota Urology, Woodbury, Minnesota , Alexis E. TeAlexis E. Te Weill Cornell Medicine, New York, New York , Jeffrey DannJeffrey Dann Advanced Urology Institute, Daytona Beach, Florida , Jessica M. DeLongJessica M. DeLong Urology of Virginia PLLC, Virginia Beach, Virginia , Steven B. BrandesSteven B. Brandes Columbia University, New York, New York , Judith C. HagedornJudith C. Hagedorn University of Washington, Seattle, Washington , Richard LevinRichard Levin Chesapeake Urology Research Associates, Annapolis, Maryland , Amy SchlaiferAmy Schlaifer Academic Urology & Urogynecology of Arizona, Phoenix, Arizona , Euclid DeSouzaEuclid DeSouza Adult and Pediatric Urology PC, Omaha, Nebraska , David DiMarcoDavid DiMarco Oregon Urology Institute, Springfield, Oregon , Brad A. EricksonBrad A. Erickson University of Iowa Hospitals and Clinics, Iowa City, Iowa , Richard NataleRichard Natale Carolina Urology Partners PLLC, Concord, North Carolina , Douglas A. HusmannDouglas A. Husmann Mayo Clinic, Rochester, Minnesota , Allen MoreyAllen Morey UT Southwestern Medical Center, Dallas, Texas , Carl OlssonCarl Olsson Integrated Medical Professionals, New York, New York , and Ramón VirasoroRamón Virasoro Urology of Virginia PLLC, Virginia Beach, Virginia View All Author Informationhttps://doi.org/10.1097/JU.0000000000002346AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Abstract 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. Abbreviations and Acronyms AE adverse event DCB drug-coated balloon DVIU direct vision internal urethrotomy IIEF International Index of Erectile Function IPSS International Prostate Symptom Score PK pharmacokinetic PROM patient-reported outcomes measure PVR post-void residual Qmax maximum urinary flow rate QoL quality of life Urethral stricture occurs at a rate of 0.2%–0.6% in the male population and accounts for hundreds of millions of dollars of health care costs yearly.1 The gold standard treatment is urethroplasty, with success rates ranging from 80%–95%, depending on stricture characteristics.2–4 Despite guidelines encouraging urethroplasty for longer or recurrent strictures, the vast majority are treated endoscopically.5–8 Endoscopic treatments include direct vision internal urethrotomy (DVIU) and urethral dilation, with success rates of 50%–70% for short, treatment-naïve strictures and a lower success for recurrent strictures.9–13 One area of research aimed at improving endoscopic therapy has been the addition of adjunct medication such as mitomycin C into the stricture after DVIU/dilation.14 The Optilume® urethral drug-coated balloon (DCB) builds on this success in that it combines mechanical dilation of the stricture with local, circumferential delivery of paclitaxel in a single balloon. Similar to mitomycin C, paclitaxel inhibits fibroblast growth and scar formation. Previous publications of phase I/II studies have shown that men treated with Optilume have a functional success rate of 70% at 2 years.15 Results of a phase III, single-blind, randomized, controlled trial of Optilume vs standard endoscopic therapy are reported here. Materials and Methods Study Design and Participants ROBUST III is a multicenter, single-blind, randomized, controlled trial of the safety and efficacy of the Optilume DCB for treatment of anterior urethral strictures (clinicaltrials.gov NCT03499964). The study included a nonrandomized arm of 15 participants for paclitaxel pharmacokinetic (PK) assessments. Eligible participants were adult males with anterior strictures ≤12Fr and ≤3 cm in length, ≥2 prior endoscopic treatments, International Prostate Symptom Score (IPSS) ≥11 and maximum urinary flow rate (Qmax) <15 ml per second. Participants with previous urethroplasty, hypospadias repair, lichen sclerosis or unresolved confounding etiologies (eg bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded. All participants provided written informed consent. An independent data monitoring committee oversaw the study and a clinical events committee adjudicated adverse events (AEs). Randomization and Blinding Eligible participants were randomized prior to the index procedure in a 2:1 allocation of treatment vs control, stratified by prior pelvic radiotherapy (yes/no) and number of prior endoscopic treatments (<5 vs ≥5). Randomized participants were blinded to treatment through 6 months, which was the time point of the primary end point. Prior to 6 months, unblinding could occur only if medically necessary (eg recurrent stricture requiring intervention). Interventions and Followup For participants randomized to treatment, strictures were pretreated with an uncoated balloon or DVIU to ≥20Fr. Direct dilation with the DCB, though possible, was avoided to limit the chance that a subject would get 2 doses of paclitaxel if the stricture did not sufficiently dilate with the first dilation. Balloon sizes were selected based on lumen diameter and stricture length was measured via urethrogram with instructions to select a balloon length that allowed 0.5–1 cm overlap into normal tissue in both directions. Inflation to rated burst pressure occurred for ≥5 minutes to allow complete stricture dilation and paclitaxel delivery. The DCB was then removed and a 12Fr–14Fr Foley catheter inserted. Control participants were treated by the endoscopic method that was considered standard of care for the site, which included serial dilation with urethral sounds, DVIU, balloon dilation or a combination; a lumen size goal was not prespecified. A 12Fr–14Fr Foley catheter was inserted. Participants randomized to the control arm were eligible to cross over to receive the DCB only if stricture recurrence was confirmed via recurrent symptoms, decreased flow and a stricture diameter 0.999 Anatomical location: 0.319 Bulbar 45/47 (95.7) 71/79 (89.9) Penile 2/47 (4.3) 8/79 (10.1) Mean±SD stricture measurements: Length (cm) 1.72±0.73 1.63±0.76 0.528 Diameter (mm) 2.33±0.88 2.46±0.96 0.470 Prior dilations: Mean§ 4.3±7.5 3.2±1.73 0.321 Median 3.0 3.0 No. ≥5 overall (%) 10/48 (20.8) 13/79 (16.5) 0.636 Some rows contain fewer than 48 or 79 participants due to missing demographic or clinical data. P values based on unpaired t-test for continuous variables and Fisher's exact test for categorical variables. Pacific Islander, Asian or Native American Single subject with 53 prior dilations, average is 3.3 when excluding this subject. Control group strictures were treated with an uncoated balloon (58.3%; 24Fr in 16, 28Fr in 1 and 30Fr in 11), DVIU (25.0%) or urethral sounds (16.7%). DCB group strictures were predilated with an uncoated balloon (92.4%), DVIU (5.1%) or both (2.5%). The most used DCB size was 30Fr and either 30 mm (28.2%) or 50 mm (60.8%) length. Average time between insertion and removal of the DCB was 8 minutes and 42 seconds. Posttreatment lumen diameter was estimated by urethrography; the mean was 24Fr in both groups. Efficacy Results At 6 months, anatomical success was 74.6% in the DCB group and 26.8% in the control group, resulting in an estimated difference of 44.4% using multiple imputation and meeting the primary efficacy end point of the study (p <0.0001; table 2). The treatment effect was consistent across some prespecified clinical subgroups, including participants with ≥5 vs <5 prior endoscopic treatments and stricture length ≥2 vs <2 cm. There were too few participants in some etiology categories and too few with penile strictures or radiation to comment on the impact of these subgroups on success (fig. 2). A subset analysis of 11 control participants dilated with a 30Fr balloon compared to 70 participants dilated with a 30Fr DCB showed results similar to the overall findings: 22% vs 75% success at 6 months (p <0.01). Table 2. Primary efficacy end point results End Point Standard of Care Optilume DCB Difference* (95% CI) p Value* No. pts 48 79 % Stricture-free (No./total No.) 26.8 (11/41) 74.6 (50/67) 44.4 (27.6–61.1) <0.0001 No. subject accountability: Pass urethral lumen test at 6 mos 11 50 Failed urethral lumen test at 6 mos† 12 15 Repeat intervention prior to 6 mos‡ 18 2 Missing cystoscopy at 6 mos 7 12 Estimates of the difference (Optilume vs control), 95% CI and 1-sided p value are based on the model-based estimates resulting from multiple-imputation of missing data. Urethral lumen test included 105 subjects assessed with 16Fr flexible cystoscope and 3 with 14Fr Foley catheter. Repeat intervention includes participants receiving additional DVIU, dilation or urethroplasty, including those in control arm with confirmed stricture recurrence (lumen <12Fr by urethrography with recurrent symptoms) who opted to cross over to receive treatment with the Optilume DCB. Figure 2. Subgroup analysis of anatomical success for specified subgroups. Kaplan-Meier estimates of freedom from repeat intervention through 1 year were significantly higher for the DCB group as compared to the control group (83.2% vs 21.7%, p <0.0001; fig. 3). Both groups showed a significant increase in Qmax from baseline to 30 days, with control participants exhibiting a marked deterioration beginning at the 3-month visit. By 1 year, the average Qmax in the DCB group was nearly double that of the control group (table 3). The post-void residual (PVR) urine volume in the control group was higher than baseline at 6 months and 1 year. Figure 3. Kaplan-Meier curve of freedom from repeat intervention through 1 year. Table 3. Additional outcome measures Measure Baseline 30 Days 3 Mos 6 Mos 1 Yr Mean±SD IPSS (No. pts): Optilume 22.0±6.8 (79) 7.6±5.7 (78) 7.4±5.8 (74) 8.3±6.2 (71) 9.0±7.1 (67) Standard of care 22.8±7.0 (47) 9.5±7.4 (47) 12.4±9.2 (45) 15.4±9.6 (43) 19.9±7.5 (42) Mean±SD IPSS—QoL (No. pts): Optilume 4.5±1.3 (79) 1.7±1.4 (78) 1.6±1.4 (74) 1.7±1.3 (71) 1.9±1.5 (67) Standard of care 4.7±1.2 (47) 2.0±1.6 (47) 2.7±1.8 (45) 3.4±1.8 (43) 4.0±1.3 (42) Mean±SD ml/sec Qmax (No. pts): Optilume 7.6±3.4 (78) 18.3±9.1 (75) 18.6±10.9 (71) 16.6±8.9 (67) 15.5±9.0 (65) Standard of care 7.4±3.5 (47) 15.8±8.5 (44) 13.3±9.3 (39) 11.1±7.6 (44) 7.6±4.0 (41) Mean±SD ml PVR urine (No. pts): Optilume 109.8±116.9 (77) 75.6±86.2 (75) 103.4±134.4 (70) 73.1±117.7 (67) 94.6±121.8 (66) Standard of care 133.8±155.1 (47) 79.1±87.3 (45) 113.4±124.2 (41) 141.4±194.1 (44) 181.5±201.7 (42) Mean±SD IIEF (No. pts): Optilume 5.8±2.9 (72) 5.9±2.8 (75) 6.6±2.7 (71) 6.5±2.8 (68) 6.9±3.0 (59) Standard of care 6.0±3.2 (46) 5.7±3.0 (45) 6.1±3.0 (40) 6.6±3.2 (30) 5.8±2.7 (13) Trends in IPSS and IPSS QoL were similar to Qmax. Both groups showed improvements in scores through 30 days; however, average scores for the control group deteriorated sharply at the 3-month visit and returned to near baseline levels by 1 year, while the DCB group remained significantly improved (table 3). Safety Results No subject experienced a primary safety end point event through 3 months. AE types and rates were well matched between groups, except that the DCB group had higher rates of post-procedure hematuria and dysuria compared to controls (11.4% vs 2.1% for both event types). These events were judged as mild in nature and resolved within 30 days in 10 of 11 men. Serious AEs occurred in 16.7% of controls and 10.1% of the DCB group. One serious event of urinary tract infection was judged as possibly related to the device/procedure in each group. There was no change in sexual function as measured by the IIEF in either group (table 3). Systemic exposure to paclitaxel was minimal, with average plasma concentration rising above the limit of quantitation at 1 hour (0.12 ng/ml) and 3 hours (0.11 ng/ml) post-procedure. Average paclitaxel concentration in the urine was highest immediately post-procedure (414.4 ng/ml), and decreased to 13.8 ng/ml at Foley removal and to below the limit of quantitation by 30 days post-procedure. Drug concentration in semen was 2.99 ng/ml at 30 days, 0.48 ng/ml at 3 months and 0.12 ng/ml at 6 months; paclitaxel was detected in measurable quantities in 60% (9/15), 39% (5/13) and 8.3% (1/12) of participants, respectively. Discussion The Optilume DCB is safe and has superior success rates compared to standard endoscopic management with DVIU/dilation in men with recurrent urethral stricture <3 cm in length. These results were consistent across stricture lengths and number of prior interventions. Success by several different measures (anatomical success, freedom from repeat intervention, Qmax and IPSS) were consistently higher with DCB. Definitive assessments of subgroups such as some stricture etiologies, penile strictures and participants with prior pelvic radiation were not possible due to small sample size. The anatomical success rates of DIVU and urethral dilation have been shown to be similar to each other in a randomized trial.9 One-year success may be as high as 70% for treatment-naïve, short, bulbar strictures. However, recurrent strictures, penile strictures or strictures undergoing repeat endoscopic treatment all represent high-risk strictures with 1-year success rates far less than 50%.10,11 Despite low success rates, endoscopic therapies remain the most common procedures for urethral stricture, likely owing to their minimally invasive nature.5,6 Urethroplasty is the gold standard urethral stricture treatment, with anatomical success rates of 80%–95% depending on stricture characteristics. However, urethroplasty is more invasive than endoscopic treatment and can be associated with complications of pain, neuropathy and sexual dysfunction.18 The choice between urethroplasty and endoscopic therapy is a function of surgeon skill set, success rates, side effects and cost. Previous cost-benefit analyses and subsequent guideline statements suggest that 1 endoscopic treatment be pursued for treatment-naïve, short, bulbar strictures; any high-risk stricture should be managed with urethroplasty, including any recurrent stricture, owing to low success rates with endoscopic therapy in these scenarios.8,19 Still, nearly twice as many men undergo another endoscopic treatment rather than urethroplasty even when they have failed 2 prior endoscopic treatments.20 This discrepancy between the science-based recommendations and utilization rates of endoscopic therapy may represent problems with access to urethroplasty experts, reluctance to refer patients to urethroplasty experts or patient preference, perhaps related to out-of-pocket expense, recovery time or side effects. There are many ways to measure success of urethral stricture treatment, but these can generally be categorized as freedom from repeat treatment, anatomical success and functional success.21 Freedom from repeat treatment is important in that it measures the consumption of important health resources; this tends to be the measure with the highest success rates because not all men with anatomical narrowing or symptoms pursue repeat treatment.22 The most commonly used anatomical measure is the ability to atraumatically pass a flexible adult cystoscope through the treated area. Functional success includes measures such as Qmax, patient-reported outcomes measures (PROMs) and PVR. Although PROMs better represent what is important to the patient, anatomical success has the advantage of not being influenced by comorbid conditions like prostatic obstruction or cystopathy, which can impact PROMs and Qmax. Because each of these outcome measures has its own advantages and disadvantages, we included all of them in our assessment. In the current study, each outcome measure showed superiority of the DCB over standard endoscopic management. A Forest plot demonstrates that 6-month anatomical success favored DCB in all subgroups, although some subgroups were too small for definitive comparison, including etiology, stricture location and previous radiation (fig. 2). Still, these findings demonstrate the robustness of the results with DCB across several subgroups. Minor AEs that were more common with DCB were hematuria and dysuria. This may represent delayed wound healing as would be expected with the mechanism of action for paclitaxel. These events were judged as being mild and typically resolved within 30 days. Likewise, erectile function as measured by IIEF did not change from baseline in either the DCB or DVIU/dilation group. Finally, in a subgroup of men who had their urine and seminal level of paclitaxel followed after treatment, we show that urine levels drop below the level of quantification by 30 days and seminal levels by 6 months. Given the presence of paclitaxel in semen for up to 6 months, it is recommended that men receiving this treatment utilize contraception through 6 months posttreatment if their partner has child-bearing potential. Limitations of our study include 1) surgeons were not blinded to the type of treatment; this might bias their interpretation of cystoscopic findings or the decision to proceed with repeat treatment. However, other outcomes that would not be biased by the surgeon (ie IPSS, Qmax and PVR) also supported the superiority of Optilume. 2) Patients were unblinded after 6 months; unblinding could have biased some secondary outcomes. For instance, the chance to cross over to the active arm may have impacted the control participants' desire to undergo repeat treatment. However, outcomes that would not be impacted by unblinding (Qmax and PVR) were superior with DCB, both before and after the unblinding. 3) The primary outcome was missing for 7 control and 12 DCB participants; however, even assuming worst-case scenario, wherein all 7 controls were successes and all 12 DCBs were failures, DCB was still superior at 63% vs 38% for controls. 4) It is possible that the better results seen with DCB were due to dilation to a larger lumen size than in controls; however, posttreatment urethrogram estimated the lumen diameters were not different between groups, and a subset analysis of just patients treated with 30Fr balloons showed similar findings to the overall analysis. 5) Repeated endoscopic treatments have been shown to make eventual urethroplasty more complex.23 We do not know how DCB might impact the complexity or success of reconstruction in men who progress to urethroplasty. Conclusions The results of this randomized controlled trial support that Optilume DCB is safe and superior to standard DVIU/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. Superior outcomes were observed for freedom from repeat treatment at 1 year, anatomical success at 6 months and functional success at 1 year. We will continue to follow these men for 5 years. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful DVIU/dilation but who want to avoid or delay urethroplasty. References 1. : Male urethral stricture disease. J Urol 2007; 177: 1667. Link, Google Scholar 2. : Free graft augmentation urethroplasty for bulbar urethral strictures: which technique is best? A systematic review. Eur Urol 2021; 80: 57. Google Scholar 3. : Stricture recurrence after urethroplasty: a systematic review. J Urol 2009; 182: 1266. Link, Google Scholar 4. : Anastomotic urethroplasty for bulbar urethral stricture: analysis of 168 patients. J Urol 2002; 167: 1715. Link, Google Scholar 5. : Adult anterior urethral strictures: a national practice patterns survey of board certified urologists in the United States. J Urol 2007; 177: 685. Link, Google Scholar 6. : Practice patterns in the treatment of urethral stricture among American urologists: a paradigm change?Urology 2015; 86: 830. Google Scholar 7. : Trends in stricture management among male Medicare beneficiaries: underuse of urethroplasty?Urology 2011; 77: 481. Google Scholar 8. : Male urethral stricture: American Urological Association guideline. J Urol 2017; 197: 182. Link, Google Scholar 9. : Internal urethrotomy versus dilation as treatment for male urethral strictures: a prospective, randomized comparison. J Urol 1997; 157: 98. Link, Google Scholar 10. : Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful?J Urol 1998; 160: 356. Link, Google Scholar 11. : Urethrotomy has a much lower success rate than previously reported. J Urol 2010; 183: 1859. Link, Google Scholar 12. : Assessment of a new transurethral balloon dilation catheter in the treatment of urethral stricture disease. Urology 2000; 55: 408. Google Scholar 13. : Internal urethrotomy in the management of anterior urethral strictures: long-term followup. J Urol 1996; 156: 73. Link, Google Scholar 14. : A systematic review and meta-analysis of adjuncts to minimally invasive treatment of urethral stricture in men. Eur Urol 2021: 80: 467. Google Scholar 15. : A drug-coated balloon treatment for urethral stricture disease: two-year results from the ROBUST I study. Can Urol Assoc J 2021; 15: 20. Google Scholar 16. : Prospective evaluation of the American Urological Association symptom index and peak urinary flow rate for the followup of men with known urethral stricture disease. J Urol 2002; 168: 2051. Link, Google Scholar 17. : A drug-coated balloon treatment for urethral stricture disease: interim results from the ROBUST I study. Can Urol Assoc J 2020; 14: 187. Google Scholar 18. : Extended complications of urethroplasty. Int Braz J Urol 2005; 31: 315. Google Scholar 19. : What is the most cost-effective treatment for 1 to 2-cm bulbar urethral strictures: societal approach using decision analysis. Urology 2006; 67: 889. Google Scholar 20. : High regional variation in urethroplasty in the United States. J Urol 2015; 193: 179. Link, Google Scholar 21. : Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol. Urology 2014; 84: 213. Google Scholar 22. : Clinical significance of cystoscopic urethral stricture recurrence after anterior urethroplasty: a multi-institution analysis from Trauma and Urologic Reconstructive Network of Surgeons (TURNS). World J Urol 2019; 37: 2763. Google Scholar 23. : Delayed reconstruction of bulbar urethral strictures is associated with multiple interventions, longer strictures and more complex repairs. J Urol 2018; 199: 515. Link, Google Scholar Support: Urotronic, Inc. is the sole funder of this study. The authors had access to all the primary data and drafted all parts of the manuscript. Urotronic, Inc. had no role in the final approval of the manuscript or the decision to publish. Conflicts of Interest: SPE: Boston Scientific, Percuvision; SC: Paladin, Acerus Pharma, Coloplast, SMSNA/Boston Scientific; MJE: Coloplast, Medtronic; AS: AUUA; RN: Boston Scientific; AM: Coloplast, Boston Scientific; CO: Exilixis Corp. Ethics Statement: Institutional review board or research ethics board approval was obtained for all sites (IRB No. STUDY00005058). This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CCBY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.© 2022 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of UrologyDec 29, 2021, 12:00:00 AMEditorial CommentJournal of UrologyDec 29, 2021, 12:00:00 AMEditorial Comment Volume 207Issue 4April 2022Page: 866-875 Advertisement Copyright & Permissions© 2022 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.Keywordslower urinary tract symptomsurinary bladder neck obstructionurethral strictureMetricsAuthor Information Sean P. Elliott University of Minnesota, Minneapolis, Minnesota *Correspondence: Department of Urology, University of Minnesota, 420 Delaware St. SE, MMC 394Minneapolis, Minnesota 55405 telephone: 612-625-7486; FAX: 612-626-0428; E-mail Address: [email protected] More articles by this author Karl Coutinho New Jersey Urology LLC, Millburn, New Jersey More articles by this author Kaiser J. Robertson Chesapeake Urology, Hanover, Maryland More articles by this author Richard D'Anna Arkansas Urology, Little Rock, Arkansas More articles by this author Kent Chevli Western New York Urology Associates, Cheektowaga, New York More articles by this author Serge Carrier McGill University Health Center, Montreal, Quebec, Canada More articles by this author Melanie Aube-Peterkin McGill University Health Center, Montreal, Quebec, Canada More articles by this author Christopher H. Cantrill Urology San Antonio, San Antonio, Texas More articles by this author Michael J. Ehlert Metro Urology, a division of Minnesota Urology, Woodbury, Minnesota More articles by this author Alexis E. Te Weill Cornell Medicine, New York, New York More articles by this author Jeffrey Dann Advanced Urology Institute, Daytona Beach, Florida More articles by this author Jessica M. DeLong Urology of Virginia PLLC, Virginia Beach, Virginia More articles by this author Steven B. Brandes Columbia University, New York, New York More articles by this author Judith C. Hagedorn University of Washington, Seattle, Washington More articles by this author Richard Levin Chesapeake Urology Research Associates, Annapolis, Maryland More articles by this author Amy Schlaifer Academic Urology & Urogynecology of Arizona, Phoenix, Arizona More articles by this author Euclid DeSouza Adult and Pediatric Urology PC, Omaha, Nebraska More articles by this author David DiMarco Oregon Urology Institute, Springfield, Oregon More articles by this author Brad A. Erickson University of Iowa Hospitals and Clinics, Iowa City, Iowa More articles by this author Richard Natale Carolina Urology Partners PLLC, Concord, North Carolina More articles by this author Douglas A. Husmann Mayo Clinic, Rochester, Minnesota More articles by this author Allen Morey UT Southwestern Medical Center, Dallas, Texas More articles by this author Carl Olsson Integrated Medical Professionals, New York, New York More articles by this author Ramón Virasoro Urology of Virginia PLLC, Virginia Beach, Virginia More articles by this author Expand All Support: Urotronic, Inc. is the sole funder of this study. The authors had access to all the primary data and drafted all parts of the manuscript. Urotronic, Inc. had no role in the final approval of the manuscript or the decision to publish. Conflicts of Interest: SPE: Boston Scientific, Percuvision; SC: Paladin, Acerus Pharma, Coloplast, SMSNA/Boston Scientific; MJE: Coloplast, Medtronic; AS: AUUA; RN: Boston Scientific; AM: Coloplast, Boston Scientific; CO: Exilixis Corp. Ethics Statement: Institutional review board or research ethics board approval was obtained for all sites (IRB No. STUDY00005058). Advertisement Advertisement PDF DownloadLoading ...
Referência(s)