Safety and Efficacy of Aquablation in Men 80 Years or Older: An analysis of the International Collaborative Aquablation Research Urology Society (ICARUS) Real-World database

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Safety and Efficacy of Aquablation in Men 80 Years or Older: An analysis of the International Collaborative Aquablation Research Urology Society (ICARUS) Real-World database | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Safety and Efficacy of Aquablation in Men 80 Years or Older: An analysis of the International Collaborative Aquablation Research Urology Society (ICARUS) Real-World database Liam Murad, Aalya Hamouda, David Bouhadana, Nick Lee, Ilan Ohana, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6239131/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Oct, 2025 Read the published version in World Journal of Urology → Version 1 posted 12 You are reading this latest preprint version Abstract Purpose Aquablation is under-researched, especially in the elderly. As older patients face higher risks of surgical complications, this study aims to evaluate the safety and efficacy of Aquablation in octogenarians. Methods This retrospective, multi-center study includes 2,136 patients who underwent Aquablation between 2018 and 2024. Patients were divided into two cohorts, ≥ 80 and < 80 years of age, consisting of 206 and 1930 men, respectively. Data included baseline characteristics, operative characteristics, and post-operative functional outcomes. Peri-operative events were compared. Results Men ≥ 80 had higher rates of anxiety/depression (32% vs 16%, p = 0.0032), 5α-reductase inhibitor use (35% vs 19%, p = 0.0009), and anticoagulation (56% vs 24%, p < 0.0001). Mean prostate volume was similar between groups, but men ≥ 80 were less likely to have a median lobe (52% vs 63%, p = 0.003). Both groups showed similar improvements in peak urinary flow rate, post-void residual, International Prostate Symptom Score and quality of life. Men ≥ 80 had higher rates of take-back for cystoscopy/clot evacuation (4.4% vs 1.9%, p = 0.034), transfusions (2.9% vs 0.5%, p = 0.003) and 30-day readmissions (4.2% vs 0.7%, p = 0.002). Age and urinary retention were associated with a composite bleeding outcome. There were no changes in erectile function and no differences in retrograde ejaculation between groups. Conclusion This study is the first to assess Aquablation's safety and efficacy across all ages. Aquablation offers similar voiding improvements in men aged ≥ 80 as in younger men, with slightly higher perioperative risks. Thus, Aquablation should be considered for well-selected, elderly patients with significant BPH who wish to preserve sexual function. Aquablation Benign Prostatic Hyperplasia BPH Urology Octogenarians Figures Figure 1 Introduction Benign prostatic hyperplasia (BPH) is a condition prevalent amongst older men, which can lead to lower urinary tract symptoms (LUTS) that considerably impair quality of life (QoL).[ 1 ] There is an increasing plethora of available surgical treatment options for the management of BPH, and recently there has been an increased adoption of surgical therapies that can avoid side effects and improve outcomes for men. Aquablation has emerged as an effective alternative to traditional surgical approaches, such as transurethral resection of the prostate (TURP) and holmium laser enucleation (HoLEP). This novel surgical approach utilizes a robotically-assisted, image-guided heat-free waterjet to ablate prostatic tissue, delivering excellent urinary and sexual outcomes in predictable surgical times that are independent of prostate volume.[ 2 ] Previous retrospective post-hoc analyses from the WATER I and WATER II clinical trials demonstrated that men undergoing Aquablation ≥ 65 years old had similar functional and surgical outcomes compared to younger men.[ 3 ] At 3-year follow-up, men ≥ 65 years old had reductions in total International Prostate Symptom Score (IPSS) compared to younger men, with similar increases in peak urinary flow rate (Qmax), no significant differences between age groups, and comparable rates of ejaculatory dysfunction and annual retreatment.[ 3 ] The follow-up study by Gilling et al, at 5 years post-Aquablation, showed no significant difference in IPSS reduction between those younger or older than 65 years old, thereby demonstrating that symptom relief provided by Aquablation is durable and comparable between these two age groups.[ 4 ] However, WATER I and II excluded men ≥ 80 years old, and no previous research has examined whether these outcomes extend to men in even older age groups, particularly in octogenarians – an age group expected to triple in number in the upcoming two decades.[ 5 ] Given the increasing life expectancy and growing number of elderly men seeking surgical management for BPH, further research is warranted to determine whether Aquablation is similarly efficacious and safe in this age group. Treatment of BPH in older adults is crucial, as LUTS can significantly impact their overall health, increasing the risk of falls and other health complications.[ 6 ] With advancing age, patients requiring urological care face a greater burden of complications and increased mortality risk, as evidenced by studies on octogenarian and nonagenarian populations. Hospitalization data indicate that elderly patients require more intensive monitoring, experience prolonged hospital stays, and face higher rates of post-surgical complications such as infection, bleeding or mortality, particularly following major urological interventions.[ 7 , 8 ] Despite this, there are many fit and functional older men who report a strong interest in preserving erectile and ejaculatory function, and thus should be offered a surgical solution for BPH congruent with their goals.[ 9 ] This study aims to evaluate the safety and efficacy of Aquablation in men over 80 years of age. Given the age exclusions in the pivotal WATER clinical trials, real-world data remain necessary to assess performance in this population. Recent findings suggest that Aquablation may offer advantages in terms of operative efficiency and reduced catheterization times, potentially benefiting elderly patients at higher risk of post-surgical complications.[ 10 ] Materials and Methods Study Design and Patient Population This retrospective, multicenter study analyzed data from the International Collaborative Aquablation Research Urology Society (ICARUS) database, which includes a prospectively collected series of cases from four high-volume international centers. The database includes 2,136 men treated for symptomatic BPH with Aquablation between 2019 and 2024. Patients were divided into two cohorts based on age: men ≥ 80 years old (n = 206) and men < 80 years old (n = 1,930). Surgical Technique Aquablation procedures were carried out under general anesthesia using a robotic system that employs real-time ultrasound guidance for precise waterjet ablation.[ 11 ] Relevant operative parameters analyzed included procedure duration, time dedicated specifically to Aquablation treatment, blood transfusions and takebacks for cystoscopy/clot evacuation. The Aquablation procedure performed in our cohort incorporated modernized protocols that involve at least two-pass resections for maximum tissue removal, followed by focal bladder neck electrocautery for hemostasis to minimize postoperative bleeding.[ 12 , 13 ] Outcome Measures Baseline cohort variables included age, LUTS/BPH pharmacotherapy, anticoagulant use (categorized as aspirin 81mg, other antiplatelet agent [e.g. aspirin 325mg, clopidogrel, prasugrel], or warfarin/novel oral anticoagulant), prostate volume, PSA, prostate health index (PHI), Qmax, post-void residual (PVR) volume, median lobe presence, IPSS, IPSS-Quality of Life (QoL) and Sexual Health Inventory for Men (SHIM) patient-reported outcome measures. Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) data was limited in ICARUS, so ejaculatory function was also categorically recorded by sites as normal antegrade ejaculation, antegrade ejaculation but reduced or decreased volume, and retrograde ejaculation. Primary study endpoints included improvements in IPSS, QoL, Qmax, and PVR assessed at regular intervals until 24 months postoperatively. Secondary outcomes assessed operative safety metrics, including operative time, transfusion rates, perioperative complications, sexual function (SHIM and ejaculatory dysfunction rates) and durability, as measured by retreatment rates and continued medication use for recurrent LUTS. Data Collection and Follow-up Patient data were collected via a combination of electronic medical record data extraction and direct chart reviews. Follow-up assessments were performed at defined intervals (1–3, 4–8, 9–12, and 24 months postoperatively) and included standardized evaluations of symptom burden (IPSS), urinary function (Qmax, PVR), and sexual function (SHIM). Adverse events were classified according to the Clavien-Dindo grading system. Statistical Analysis Baseline characteristics and outcome measures were summarized using descriptive statistics. Continuous variables were presented as means ± standard deviations or medians with interquartile ranges (IQR) and compared using ANOVA or the Mann-Whitney U test when applicable. Categorical variables were reported as frequencies and percentages and analyzed using the Chi-square test or Fisher’s exact test when applicable. To identify independent predictors of a composite bleeding outcome (defined by the occurrence of either transfusion or cystoscopy with clot evacuation), multivariable logistic regression was performed. Candidate variables were selected based on clinical relevance and statistical significance in univariable analyses. However, anticoagulant use was not included in the multivariate analysis due to high proportion (> 50%) of missing data in the cohort. Statistical significance was defined as a p-value < 0.05 for all analyses. Analysis was performed using SAS version 9.4 (SAS Institute, Cary, NC). Results Demographics and Baseline Characteristics Men ≥ 80 years old had higher rates of anxiety/depression than younger men (32% vs 16%, p = 0.0032). There was no significant difference in other comorbidities between groups. Regarding medication use, men ≥ 80 years old were more likely to be prescribed 5α-reductase inhibitors (35% vs 19%, p = 0.0000) compared to those younger than 80. The same applies to anticoagulation of any kind (56% vs 24%, p < 0.0001) and aspirin 81mg (28% vs 15%, p = 0.0146). Baseline prostate volume, serum PSA and PHI values were not significantly different between groups. Men ≥ 80 years old were more likely to be in pre-operative urinary retention requiring catheterization (23% vs. 14%, p = 0.0019), but were less likely to have a median lobe (52% vs 63%, p = 0.0034). Men ≥ 80 years old had a significantly higher median PVR than those younger than 80 (143mL vs. 104mL, p = 0.0185), but for men not in retention Qmax was similar between the two groups. Baseline patient reported outcomes including IPSS and QoL were not significantly different between groups, however baseline SHIM was significantly lower in octogenarians (7.71 vs 14.73, p < 0.0001). Details regarding baseline variables are described in Supplemental Table 1 . Operative Characteristics and Complications Total operative time did not differ significantly between groups. Men ≥ 80 years old had significantly higher rates of takeback for cystoscopy with clot evacuation (4.39% vs 1.87%, p = 0.0344), blood transfusion (2.91% vs 0.52%, 0.0027), and 30-day readmission (4.23% vs 0.71%, p = 0.0020). Octogenarians also had significantly higher rates of surgical complications as described by Clavien-Dindo classification (p = 0.0409). Details on complication rates are described in Supplemental Table 2 . Multivariate analysis was performed for a composite bleeding outcome defined as transfusion or cystoscopy with clot evacuation. Older age and presence of urinary retention were significantly associated with bleeding complications ( Supplemental Table 3 ). Postoperative Qmax, PVR, and PSA At 1–3 months post-operatively, patients < 80 years had a significantly higher Qmax than octogenarians (22 ml/s vs. 18 ml/s, p = 0.0284). However, the change from baseline Qmax was similar between the two groups (12.1 vs. 10.7, p = 0.56). There was no difference in postoperative PVR between groups or change in PVR between groups (60mL vs. 47mL, p = 0.08 and − 186mL vs -143mL, p = 0.14, respectively). There were no differences in post-op PSA (4.3 and 3.04 for men ≥ 80 and < 80 respectively) or PHI (27.0 and 29.0 for men ≥ 80 and < 80 respectively) at 1–3 months. Patient reported outcome measures and Ejaculatory Function Changes in IPSS and QoL are demonstrated in Fig. 1 , respectively. Both groups showed broadly similar improvements in IPSS, QoL, Qmax, and PVR. However, at 1–3 months, men ≥ 80 years old had slightly higher IPSS values (11.29 vs. 9.45, p = 0.0066) and a higher IPSS score at 13–24 months (10.73 vs. 6.83, p = 0.0016). Average QoL worse for men ≥ 80 years old at 4–8 months (2.59 vs. 1.89, p = 0.0440), as was change in QoL at 4–8 months (-2.43 vs -1.24, p = 0.0051), but QoL was similar at other timepoints. Figure 1 a: IPSS Results Over Time for Men < 80 years vs Men ≥ 80 years. (* represents p < 0.005) Figure 1 b: IPSS QoL Results Over Time for Men < 80 years vs Men ≥ 80 years. (* represents p < 0.005) Men ≥ 80 years had lower average SHIM scores compared to those under 80 years (6.45 vs. 14.37, p < 0.0001), but there were no significant changes from baseline SHIM scores (0.31 vs. -0.23, p = 0.55). Similarly, at 1–3 months, there were no differences in rates of retrograde ejaculation between men ≥ 80 years and patients younger than 80 (15.38% vs 10.11%, p = 0.56). Four men (2.41%) in the older group underwent retreatment (TURP, HoLEP, and/or treatment of symptomatic stricture disease) during follow-up, compared to 25 (1.45%) in the group of men < 80 years old (p = 0.32). Discussion Here we present the first study examining outcomes of Aquablation in men ≥ 80 years old. The results of this study provide further evidence supporting the efficacy of Aquablation as a treatment for BPH in elderly men. Studying Aquablation specifically in men ≥ 80 years old is critically important because this age group faces unique clinical challenges and has historically been excluded from major clinical trials, including the WATER I and WATER II studies. In the United States, Medicare’s Local Coverage Determinations essentially copied the initial WATER criteria and previously restricted use of Aquablation in men aged 80 or older. This age limitation was lifted on Oct 15, 2023.[ 14 ] Sexual function does not end at age 80, and many older men are interested in preservation of sexual function.[ 15 , 16 ] As life expectancy continues to rise, and with the population of octogenarians and nonagenarians expected to increase over the next two decades, there is an urgent need to establish safe and effective treatment options for BPH, including options that preserve sexual function. Evaluating outcomes in this older population not only fills a vital knowledge gap but also helps clinicians better tailor treatment strategies, offering improvements in symptom relief, quality of life, and overall patient care for a rapidly growing – and often underserved and understudied – segment of the population. In our study, octogenarians and nonagenarians were more likely to be on anticoagulation, more likely to be on a 5-alpha reductase inhibitor, and more likely to be in urinary retention. Additionally, men ≥ 80 years old were found to be significantly less likely to have a median lobe. One possible explanation for this is that men with a median lobe may become symptomatic at earlier timepoints, potentially leading to earlier intervention and treatment.[ 17 ] In both age groups, IPSS and QoL scores improved significantly, showing largely comparable results despite some statistical variations at certain time points – an outcome consistent with findings reported in the literature. Several studies have investigated age-related outcomes of laser enucleation of the prostate, showing comparable changes in IPSS and QoL in those over 70 with younger patients.[ 18 – 22 ] Similarly, a study on photoselective vaporization of the prostate (“Greenlight”), with a cutoff of 75 years showed no notable difference in IPSS between age groups.[ 23 ] Previous research on Aquablation has demonstrated comparable reductions in IPSS and QoL for patients stratified by age with a cutoff at 65, and our findings now show similar results for patients aged 80 and older, and those younger than 80.[ 3 ] However, it should not be overlooked that while both younger men and octogenarians demonstrated significant improvements, men ≥ 80 years old had higher post-operative IPSS values at some timepoints. These findings could be due to bias or missing data, or it could suggest that while octogenarians and nonagenarians benefit from BPH surgery, they may not show the same degree of improvement. This could be related to declining detrusor function with age or may be related to a lack of bladder plasticity among older men.[ 24 , 25 ] Other studies have also demonstrated a similar trend with regards to voiding parameters between older and younger patients. Our results from the ICARUS database show that despite there being significantly higher baseline Qmax in younger patients, both age groups demonstrated a similar improvement in Qmax and reduction in PVR postoperatively. Previous studies evaluating patients undergoing laser enucleation demonstrated that there is a comparable improvement in PVR and Qmax across patients older and younger than 70 years old.[ 18 – 22 ] In our study, we have extended this analysis to Aquablation, with an age cutoff of 80, showing comparable voiding outcomes between those aged 80 and older and those younger than 80. There is a paucity of data that directly compare Aquablation with other commonly used surgical methods such as laser enucleation or TURP in terms of IPSS and QoL improvements not only in general but also across different age groups.[ 26 ] While Aquablation has shown encouraging outcomes in this population, direct comparison of Aquablation with other modalities such as HoLEP and TURP, especially regarding age-specific results, has yet to be studied. Just as with patient-reported outcomes, more surgical trials are needed to further evaluate how Aquablation compares to other commonly used surgical approaches in terms of functional outcomes. Men ≥ 80 years old undergoing Aquablation had significantly higher rates of takeback for cystoscopy or clot evacuation, blood transfusions, and 30-day readmissions. Older men in our study were also more likely to be in urinary retention, and in the ICARUS database, both older age (as a continuous variable) and presence of urinary retention requiring catheterization were independently associated with a composite bleeding complication outcome. These findings align with anticipated surgical risks in older patients. Of note, older men were also more likely to be on anticoagulation, but complete anticoagulation data was missing in a large proportion of the patients, so this factor was excluded from multivariate analysis. One study showed comparable postoperative bleeding outcomes after Aquablation for men on antithrombotic therapy, however this study only included 41 patients, and therefore may be underpowered.[ 27 ] For elderly patients, surgical risk is a major concern, particularly due to frailty. Frailty increases the risk of surgical complications, prolonged recovery, and poorer outcomes. Reduced physiological reserves, impaired healing, and comorbidities like cardiovascular disease make surgery riskier. Minimizing operative stress is critical in this population.[ 28 ] A measure of frailty, and not just numerical biological age, could also provide additional risk stratification.[ 29 ] While the study provides insights into Aquablation for older adults, it has several limitations. Retrospective design introduces selection bias (selecting patients deemed suitable by surgeons and including those from high-volume centers) and data incompleteness, limiting generalizability and conclusions on causality. Although the study was also conducted in high-volume centers, differences in individual surgeon experience, variations in Aquablation techniques and the overall learning curve, albeit small, were not accounted for.[ 30 ] With regards to the follow-up period, limiting ourselves to a 24-month period restricts the ability to evaluate long-term outcomes and late complications or retreatments. Additionally, the lack of control group limits comparisons with other BPH treatments. The cohort of patients ≥ 80 years old and above is relatively small (N = 206), which may reduce statistical power for detecting differences in infrequent outcomes but is comparable to other published series of other modalities in the literature. Finally, use of a standardized patient-reported outcome measure for ejaculatory function was not standardized in ICARUS and should be evaluated in the future. These limitations underscore the need for prospective, randomized trials with longer follow-up and comparison to other modalities to validate these findings in a wider range of clinical contexts. Conclusion In this international, multicenter retrospective study, Aquablation demonstrated comparable improvements in IPSS, QoL, PVR, and Qmax between ≥ 80 years old and those younger than 80, with improvements sustained after 2 years follow-up, with no significant changes in sexual function and no increase in surgical retreatment rates. As expected, Aquablation was associated with higher complication rates in older men, and men considering Aquablation should be counseled appropriately. As the aging population continues to grow, ensuring access to the spectrum surgical options for BPH remains an important consideration. Declarations Disclosure of potential conflicts of interest: Justo Quintas - Consultant Procept Biorobotics Rodrigues – Consultant Procept Biorobotics Glaser – Medical Advisory Board Emano Metrics Inc; Consultant Procept Biorobotics Helfand-Consultant Procept Biorobotics Zorn – Consultant Procept Biorobotics, Zenflow, Laborie, Boston Scientific. The authors declare that there are no conflicts of interest in relation to this study. Informed consent: Informed consent was obtained from all participants included in the study. Funding: The authors received no funding for this work. Competing interests: There are no competing interests to disclose. Ethics Approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was IRB approved at Endeavor Health (EH20-122). Consent to Participate: Informed consent was obtained from all individual participants included in the study. Data Availability Statement: The data analyzed in this study will not be made publicly available. Authors’ Contribution Statement: L Murad: Manuscript writing/editing, Data collection or management A Hamouda: Manuscript writing/editing D Bouhadana: Manuscript writing/editing N Lee: Manuscript writing/editing I Ohana: Manuscript writing/editing J Justo Quintas: Manuscript writing/editing J Cabral: Manuscript writing/editing A Leathead: Manuscript writing/editing A Saibi: Manuscript writing/editing N Corsi: Manuscript writing/editing Cecelia Chang: Data analysis T Rodrigues: Manuscript writing/editing, Data collection or management A P Glaser: Manuscript writing/editing, Data collection or management, Data analysis, Protocol/project development B T Helfand: Manuscript writing/editing, Data collection or management, Protocol/project development K C Zorn: Manuscript writing/editing, Data collection or management, Protocol/project development References Murad L, Bouhadana D, Nguyen D-D, Chughtai B, Zorn KC, Bhojani N et al (2023) Treating LUTS in Men with Benign Prostatic Obstruction: A Review Article. 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World J Urol 40:773–779. https://doi.org/10.1007/s00345-021-03898-w Additional Declarations No competing interests reported. Supplementary Files SupTab1.pdf SupTab2.pdf SupTab3.pdf Cite Share Download PDF Status: Published Journal Publication published 30 Oct, 2025 Read the published version in World Journal of Urology → Version 1 posted Editorial decision: Revision requested 10 Jun, 2025 Reviews received at journal 28 May, 2025 Reviewers agreed at journal 25 May, 2025 Reviewers agreed at journal 24 May, 2025 Reviewers agreed at journal 02 May, 2025 Reviews received at journal 04 Apr, 2025 Reviewers agreed at journal 26 Mar, 2025 Reviewers agreed at journal 26 Mar, 2025 Reviewers invited by journal 26 Mar, 2025 Editor assigned by journal 19 Mar, 2025 Submission checks completed at journal 19 Mar, 2025 First submitted to journal 16 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6239131","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":438826646,"identity":"0c4c473f-d8f8-485f-a744-472e6bcb91d0","order_by":0,"name":"Liam Murad","email":"","orcid":"","institution":"McGill University","correspondingAuthor":false,"prefix":"","firstName":"Liam","middleName":"","lastName":"Murad","suffix":""},{"id":438826647,"identity":"2a183deb-c9b6-49fb-8920-2e867e80a85c","order_by":1,"name":"Aalya Hamouda","email":"","orcid":"","institution":"McGill University","correspondingAuthor":false,"prefix":"","firstName":"Aalya","middleName":"","lastName":"Hamouda","suffix":""},{"id":438826648,"identity":"02e7b389-d9f2-41ff-a6c4-79f72f2554ce","order_by":2,"name":"David Bouhadana","email":"","orcid":"","institution":"McGill University","correspondingAuthor":false,"prefix":"","firstName":"David","middleName":"","lastName":"Bouhadana","suffix":""},{"id":438826649,"identity":"dd4d6304-a57d-41be-95bc-f1e90446ff74","order_by":3,"name":"Nick Lee","email":"","orcid":"","institution":"Université de Montréal","correspondingAuthor":false,"prefix":"","firstName":"Nick","middleName":"","lastName":"Lee","suffix":""},{"id":438826650,"identity":"c9850486-45c8-40d6-92ea-d219e98c5a11","order_by":4,"name":"Ilan Ohana","email":"","orcid":"","institution":"Laval University","correspondingAuthor":false,"prefix":"","firstName":"Ilan","middleName":"","lastName":"Ohana","suffix":""},{"id":438826652,"identity":"004f8b05-409d-4e56-bd64-efa678ed6211","order_by":5,"name":"Juan Justo Quintas","email":"","orcid":"","institution":"HM Hospital Universitario","correspondingAuthor":false,"prefix":"","firstName":"Juan","middleName":"Justo","lastName":"Quintas","suffix":""},{"id":438826653,"identity":"c42ec4a5-52e3-48b9-81be-78ce2bb91da2","order_by":6,"name":"Joshua Cabral","email":"","orcid":"","institution":"University of Chicago Pritzker School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Joshua","middleName":"","lastName":"Cabral","suffix":""},{"id":438826654,"identity":"f60bb24e-8d8c-4720-88cc-a21f41d604ed","order_by":7,"name":"Anouk Leathead","email":"","orcid":"","institution":"University of Montreal","correspondingAuthor":false,"prefix":"","firstName":"Anouk","middleName":"","lastName":"Leathead","suffix":""},{"id":438826655,"identity":"bd73ab33-3911-47c7-80cf-3b7ce4e09fe1","order_by":8,"name":"Augustin Saibi","email":"","orcid":"","institution":"Laval University","correspondingAuthor":false,"prefix":"","firstName":"Augustin","middleName":"","lastName":"Saibi","suffix":""},{"id":438826656,"identity":"3ebfdb4a-5340-4a6a-9867-0ef99586058a","order_by":9,"name":"Nicholas Corsi","email":"","orcid":"","institution":"University of Texas Southwestern Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Nicholas","middleName":"","lastName":"Corsi","suffix":""},{"id":438826657,"identity":"70a9afa7-b08f-41b0-afb3-d9d28eade63c","order_by":10,"name":"Cecelia Chang","email":"","orcid":"","institution":"University of Chicago Pritzker School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Cecelia","middleName":"","lastName":"Chang","suffix":""},{"id":438826658,"identity":"af2efd61-d588-4f16-a9c9-af048dcb763d","order_by":11,"name":"Tiago Rodrigues","email":"","orcid":"","institution":"Hospital Cruz Vermelha","correspondingAuthor":false,"prefix":"","firstName":"Tiago","middleName":"","lastName":"Rodrigues","suffix":""},{"id":438826659,"identity":"7a665007-fa82-4b89-a857-8b0577827d33","order_by":12,"name":"Alexander P. Glaser","email":"","orcid":"","institution":"University of Chicago Pritzker School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Alexander","middleName":"P.","lastName":"Glaser","suffix":""},{"id":438826660,"identity":"02be6e85-fa4c-4a2c-8017-f7eaa714d8a2","order_by":13,"name":"Brian T. Helfand","email":"","orcid":"","institution":"University of Chicago Pritzker School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Brian","middleName":"T.","lastName":"Helfand","suffix":""},{"id":438826662,"identity":"dd510b70-0b37-462b-8cf6-a109bcd54712","order_by":14,"name":"Kevin C. Zorn","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAElEQVRIiWNgGAWjYBACgwMMDAcgTOZjDIwNEEG8Wgwb4FrY0ojTYoxg8pgRp8WMvcfwcAFDnZz57J5vjwt32Mmbsx/e+IGhxiYalxYbnjMGh2cwsBnL3Dm73XjmmWTDnT1pxRIMx9JyG3BpkUhLOMzDwJM4QyJ3mzRv2wHGDQdyDCQYGw7j1GIm/wykRQKoJecZSIv9hvNvjH/g02IswXwAqMUApIUNpCVxw40cM7y2GPYkA7UYJBhLSKSZG89sS07ecONZmUUCHr8YHD/Y/Jmnok5OQiL52ePCNjvbDeeTN9/4UGODUwtUI4Rihgsk4FWOBJgJKxkFo2AUjIKRCAD5/FihQQpg0AAAAABJRU5ErkJggg==","orcid":"","institution":"BPHCanada Prostate Surgical Institute","correspondingAuthor":true,"prefix":"","firstName":"Kevin","middleName":"C.","lastName":"Zorn","suffix":""}],"badges":[],"createdAt":"2025-03-16 18:53:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6239131/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6239131/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00345-025-05855-3","type":"published","date":"2025-10-30T15:57:52+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":80583660,"identity":"4ca927fa-f167-49b6-b4de-3b0b168f0afe","added_by":"auto","created_at":"2025-04-15 00:09:53","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":176957,"visible":true,"origin":"","legend":"\u003cp\u003ea: IPSS Results Over Time for Men \u0026lt; 80 years vs Men ≥ 80 years. (* represents p\u0026lt;0.005)\u003c/p\u003e\n\u003cp\u003eb: IPSS QoL Results Over Time for Men \u0026lt; 80 years vs Men ≥ 80 years. (* represents p\u0026lt;0.005)\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-6239131/v1/3b8d79be2860928935ca31de.png"},{"id":95040438,"identity":"faa9a711-8787-40e8-b672-b64563ab7223","added_by":"auto","created_at":"2025-11-03 16:08:43","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":766267,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6239131/v1/1ca7c289-8efc-4c7b-a26c-b58f728b8094.pdf"},{"id":80583656,"identity":"fa891637-1f97-4039-87d4-580bde716cfe","added_by":"auto","created_at":"2025-04-15 00:09:53","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":103862,"visible":true,"origin":"","legend":"","description":"","filename":"SupTab1.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6239131/v1/6358940ea8eb9e16a43ca83f.pdf"},{"id":80584168,"identity":"bc4e816b-ac63-4fe5-b1d3-d5a84b2b1464","added_by":"auto","created_at":"2025-04-15 00:17:53","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":18807,"visible":true,"origin":"","legend":"","description":"","filename":"SupTab2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6239131/v1/ec54ed53b8a48c5414b5c260.pdf"},{"id":80583657,"identity":"d21f5888-40c6-4920-ba6b-23b3f8e98297","added_by":"auto","created_at":"2025-04-15 00:09:53","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":9534,"visible":true,"origin":"","legend":"","description":"","filename":"SupTab3.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6239131/v1/5731809983a45d1235f9f38e.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Safety and Efficacy of Aquablation in Men 80 Years or Older: An analysis of the International Collaborative Aquablation Research Urology Society (ICARUS) Real-World database","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBenign prostatic hyperplasia (BPH) is a condition prevalent amongst older men, which can lead to lower urinary tract symptoms (LUTS) that considerably impair quality of life (QoL).[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] There is an increasing plethora of available surgical treatment options for the management of BPH, and recently there has been an increased adoption of surgical therapies that can avoid side effects and improve outcomes for men. Aquablation has emerged as an effective alternative to traditional surgical approaches, such as transurethral resection of the prostate (TURP) and holmium laser enucleation (HoLEP). This novel surgical approach utilizes a robotically-assisted, image-guided heat-free waterjet to ablate prostatic tissue, delivering excellent urinary and sexual outcomes in predictable surgical times that are independent of prostate volume.[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/p\u003e \u003cp\u003ePrevious retrospective post-hoc analyses from the WATER I and WATER II clinical trials demonstrated that men undergoing Aquablation\u0026thinsp;\u0026ge;\u0026thinsp;65 years old had similar functional and surgical outcomes compared to younger men.[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] At 3-year follow-up, men\u0026thinsp;\u0026ge;\u0026thinsp;65 years old had reductions in total International Prostate Symptom Score (IPSS) compared to younger men, with similar increases in peak urinary flow rate (Qmax), no significant differences between age groups, and comparable rates of ejaculatory dysfunction and annual retreatment.[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] The follow-up study by Gilling et al, at 5 years post-Aquablation, showed no significant difference in IPSS reduction between those younger or older than 65 years old, thereby demonstrating that symptom relief provided by Aquablation is durable and comparable between these two age groups.[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eHowever, WATER I and II excluded men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old, and no previous research has examined whether these outcomes extend to men in even older age groups, particularly in octogenarians \u0026ndash; an age group expected to triple in number in the upcoming two decades.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] Given the increasing life expectancy and growing number of elderly men seeking surgical management for BPH, further research is warranted to determine whether Aquablation is similarly efficacious and safe in this age group. Treatment of BPH in older adults is crucial, as LUTS can significantly impact their overall health, increasing the risk of falls and other health complications.[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] With advancing age, patients requiring urological care face a greater burden of complications and increased mortality risk, as evidenced by studies on octogenarian and nonagenarian populations. Hospitalization data indicate that elderly patients require more intensive monitoring, experience prolonged hospital stays, and face higher rates of post-surgical complications such as infection, bleeding or mortality, particularly following major urological interventions.[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] Despite this, there are many fit and functional older men who report a strong interest in preserving erectile and ejaculatory function, and thus should be offered a surgical solution for BPH congruent with their goals.[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThis study aims to evaluate the safety and efficacy of Aquablation in men over 80 years of age. Given the age exclusions in the pivotal WATER clinical trials, real-world data remain necessary to assess performance in this population. Recent findings suggest that Aquablation may offer advantages in terms of operative efficiency and reduced catheterization times, potentially benefiting elderly patients at higher risk of post-surgical complications.[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Patient Population\u003c/h2\u003e \u003cp\u003eThis retrospective, multicenter study analyzed data from the International Collaborative Aquablation Research Urology Society (ICARUS) database, which includes a prospectively collected series of cases from four high-volume international centers. The database includes 2,136 men treated for symptomatic BPH with Aquablation between 2019 and 2024. Patients were divided into two cohorts based on age: men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old (n\u0026thinsp;=\u0026thinsp;206) and men\u0026thinsp;\u0026lt;\u0026thinsp;80 years old (n\u0026thinsp;=\u0026thinsp;1,930).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSurgical Technique\u003c/h3\u003e\n\u003cp\u003eAquablation procedures were carried out under general anesthesia using a robotic system that employs real-time ultrasound guidance for precise waterjet ablation.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] Relevant operative parameters analyzed included procedure duration, time dedicated specifically to Aquablation treatment, blood transfusions and takebacks for cystoscopy/clot evacuation. The Aquablation procedure performed in our cohort incorporated modernized protocols that involve at least two-pass resections for maximum tissue removal, followed by focal bladder neck electrocautery for hemostasis to minimize postoperative bleeding.[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e\n\u003ch3\u003eOutcome Measures\u003c/h3\u003e\n\u003cp\u003eBaseline cohort variables included age, LUTS/BPH pharmacotherapy, anticoagulant use (categorized as aspirin 81mg, other antiplatelet agent [e.g. aspirin 325mg, clopidogrel, prasugrel], or warfarin/novel oral anticoagulant), prostate volume, PSA, prostate health index (PHI), Qmax, post-void residual (PVR) volume, median lobe presence, IPSS, IPSS-Quality of Life (QoL) and Sexual Health Inventory for Men (SHIM) patient-reported outcome measures. Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) data was limited in ICARUS, so ejaculatory function was also categorically recorded by sites as normal antegrade ejaculation, antegrade ejaculation but reduced or decreased volume, and retrograde ejaculation.\u003c/p\u003e \u003cp\u003ePrimary study endpoints included improvements in IPSS, QoL, Qmax, and PVR assessed at regular intervals until 24 months postoperatively. Secondary outcomes assessed operative safety metrics, including operative time, transfusion rates, perioperative complications, sexual function (SHIM and ejaculatory dysfunction rates) and durability, as measured by retreatment rates and continued medication use for recurrent LUTS.\u003c/p\u003e\n\u003ch3\u003eData Collection and Follow-up\u003c/h3\u003e\n\u003cp\u003ePatient data were collected via a combination of electronic medical record data extraction and direct chart reviews. Follow-up assessments were performed at defined intervals (1\u0026ndash;3, 4\u0026ndash;8, 9\u0026ndash;12, and 24 months postoperatively) and included standardized evaluations of symptom burden (IPSS), urinary function (Qmax, PVR), and sexual function (SHIM). Adverse events were classified according to the Clavien-Dindo grading system.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eBaseline characteristics and outcome measures were summarized using descriptive statistics. Continuous variables were presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviations or medians with interquartile ranges (IQR) and compared using ANOVA or the Mann-Whitney U test when applicable. Categorical variables were reported as frequencies and percentages and analyzed using the Chi-square test or Fisher\u0026rsquo;s exact test when applicable. To identify independent predictors of a composite bleeding outcome (defined by the occurrence of either transfusion or cystoscopy with clot evacuation), multivariable logistic regression was performed. Candidate variables were selected based on clinical relevance and statistical significance in univariable analyses. However, anticoagulant use was not included in the multivariate analysis due to high proportion (\u0026gt;\u0026thinsp;50%) of missing data in the cohort. Statistical significance was defined as a p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 for all analyses. Analysis was performed using SAS version 9.4 (SAS Institute, Cary, NC).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eDemographics and Baseline Characteristics\u003c/h2\u003e \u003cp\u003eMen\u0026thinsp;\u0026ge;\u0026thinsp;80 years old had higher rates of anxiety/depression than younger men (32% vs 16%, p\u0026thinsp;=\u0026thinsp;0.0032). There was no significant difference in other comorbidities between groups. Regarding medication use, men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old were more likely to be prescribed 5α-reductase inhibitors (35% vs 19%, p\u0026thinsp;=\u0026thinsp;0.0000) compared to those younger than 80. The same applies to anticoagulation of any kind (56% vs 24%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) and aspirin 81mg (28% vs 15%, p\u0026thinsp;=\u0026thinsp;0.0146).\u003c/p\u003e \u003cp\u003eBaseline prostate volume, serum PSA and PHI values were not significantly different between groups. Men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old were more likely to be in pre-operative urinary retention requiring catheterization (23% vs. 14%, p\u0026thinsp;=\u0026thinsp;0.0019), but were less likely to have a median lobe (52% vs 63%, p\u0026thinsp;=\u0026thinsp;0.0034). Men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old had a significantly higher median PVR than those younger than 80 (143mL vs. 104mL, p\u0026thinsp;=\u0026thinsp;0.0185), but for men not in retention Qmax was similar between the two groups.\u003c/p\u003e \u003cp\u003eBaseline patient reported outcomes including IPSS and QoL were not significantly different between groups, however baseline SHIM was significantly lower in octogenarians (7.71 vs 14.73, p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). Details regarding baseline variables are described in \u003cb\u003eSupplemental Table\u0026nbsp;1\u003c/b\u003e.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOperative Characteristics and Complications\u003c/h3\u003e\n\u003cp\u003eTotal operative time did not differ significantly between groups. Men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old had significantly higher rates of takeback for cystoscopy with clot evacuation (4.39% vs 1.87%, p\u0026thinsp;=\u0026thinsp;0.0344), blood transfusion (2.91% vs 0.52%, 0.0027), and 30-day readmission (4.23% vs 0.71%, p\u0026thinsp;=\u0026thinsp;0.0020). Octogenarians also had significantly higher rates of surgical complications as described by Clavien-Dindo classification (p\u0026thinsp;=\u0026thinsp;0.0409). Details on complication rates are described in \u003cb\u003eSupplemental Table\u0026nbsp;2\u003c/b\u003e. Multivariate analysis was performed for a composite bleeding outcome defined as transfusion or cystoscopy with clot evacuation. Older age and presence of urinary retention were significantly associated with bleeding complications (\u003cb\u003eSupplemental Table\u0026nbsp;3\u003c/b\u003e).\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003ePostoperative Qmax, PVR, and PSA\u003c/h2\u003e \u003cp\u003eAt 1\u0026ndash;3 months post-operatively, patients\u0026thinsp;\u0026lt;\u0026thinsp;80 years had a significantly higher Qmax than octogenarians (22 ml/s vs. 18 ml/s, p\u0026thinsp;=\u0026thinsp;0.0284). However, the change from baseline Qmax was similar between the two groups (12.1 vs. 10.7, p\u0026thinsp;=\u0026thinsp;0.56). There was no difference in postoperative PVR between groups or change in PVR between groups (60mL vs. 47mL, p\u0026thinsp;=\u0026thinsp;0.08 and \u0026minus;\u0026thinsp;186mL vs -143mL, p\u0026thinsp;=\u0026thinsp;0.14, respectively). There were no differences in post-op PSA (4.3 and 3.04 for men\u0026thinsp;\u0026ge;\u0026thinsp;80 and \u0026lt;\u0026thinsp;80 respectively) or PHI (27.0 and 29.0 for men\u0026thinsp;\u0026ge;\u0026thinsp;80 and \u0026lt;\u0026thinsp;80 respectively) at 1\u0026ndash;3 months.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePatient reported outcome measures and Ejaculatory Function\u003c/h2\u003e \u003cp\u003eChanges in IPSS and QoL are demonstrated in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, respectively. Both groups showed broadly similar improvements in IPSS, QoL, Qmax, and PVR. However, at 1\u0026ndash;3 months, men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old had slightly higher IPSS values (11.29 vs. 9.45, p\u0026thinsp;=\u0026thinsp;0.0066) and a higher IPSS score at 13\u0026ndash;24 months (10.73 vs. 6.83, p\u0026thinsp;=\u0026thinsp;0.0016). Average QoL worse for men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old at 4\u0026ndash;8 months (2.59 vs. 1.89, p\u0026thinsp;=\u0026thinsp;0.0440), as was change in QoL at 4\u0026ndash;8 months (-2.43 vs -1.24, p\u0026thinsp;=\u0026thinsp;0.0051), but QoL was similar at other timepoints.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003ea: IPSS Results Over Time for Men\u0026thinsp;\u0026lt;\u0026thinsp;80 years vs Men\u0026thinsp;\u0026ge;\u0026thinsp;80 years. (* represents p\u0026thinsp;\u0026lt;\u0026thinsp;0.005)\u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eb: IPSS QoL Results Over Time for Men\u0026thinsp;\u0026lt;\u0026thinsp;80 years vs Men\u0026thinsp;\u0026ge;\u0026thinsp;80 years. (* represents p\u0026thinsp;\u0026lt;\u0026thinsp;0.005)\u003c/p\u003e \u003cp\u003eMen\u0026thinsp;\u0026ge;\u0026thinsp;80 years had lower average SHIM scores compared to those under 80 years (6.45 vs. 14.37, p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), but there were no significant changes from baseline SHIM scores (0.31 vs. -0.23, p\u0026thinsp;=\u0026thinsp;0.55). Similarly, at 1\u0026ndash;3 months, there were no differences in rates of retrograde ejaculation between men\u0026thinsp;\u0026ge;\u0026thinsp;80 years and patients younger than 80 (15.38% vs 10.11%, p\u0026thinsp;=\u0026thinsp;0.56).\u003c/p\u003e \u003cp\u003eFour men (2.41%) in the older group underwent retreatment (TURP, HoLEP, and/or treatment of symptomatic stricture disease) during follow-up, compared to 25 (1.45%) in the group of men\u0026thinsp;\u0026lt;\u0026thinsp;80 years old (p\u0026thinsp;=\u0026thinsp;0.32).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eHere we present the first study examining outcomes of Aquablation in men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old. The results of this study provide further evidence supporting the efficacy of Aquablation as a treatment for BPH in elderly men. Studying Aquablation specifically in men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old is critically important because this age group faces unique clinical challenges and has historically been excluded from major clinical trials, including the WATER I and WATER II studies. In the United States, Medicare\u0026rsquo;s Local Coverage Determinations essentially copied the initial WATER criteria and previously restricted use of Aquablation in men aged 80 or older. This age limitation was lifted on Oct 15, 2023.[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] Sexual function does not end at age 80, and many older men are interested in preservation of sexual function.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] As life expectancy continues to rise, and with the population of octogenarians and nonagenarians expected to increase over the next two decades, there is an urgent need to establish safe and effective treatment options for BPH, including options that preserve sexual function. Evaluating outcomes in this older population not only fills a vital knowledge gap but also helps clinicians better tailor treatment strategies, offering improvements in symptom relief, quality of life, and overall patient care for a rapidly growing \u0026ndash; and often underserved and understudied \u0026ndash; segment of the population.\u003c/p\u003e \u003cp\u003eIn our study, octogenarians and nonagenarians were more likely to be on anticoagulation, more likely to be on a 5-alpha reductase inhibitor, and more likely to be in urinary retention. Additionally, men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old were found to be significantly less likely to have a median lobe. One possible explanation for this is that men with a median lobe may become symptomatic at earlier timepoints, potentially leading to earlier intervention and treatment.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eIn both age groups, IPSS and QoL scores improved significantly, showing largely comparable results despite some statistical variations at certain time points \u0026ndash; an outcome consistent with findings reported in the literature. Several studies have investigated age-related outcomes of laser enucleation of the prostate, showing comparable changes in IPSS and QoL in those over 70 with younger patients.[\u003cspan additionalcitationids=\"CR19 CR20 CR21\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] Similarly, a study on photoselective vaporization of the prostate (\u0026ldquo;Greenlight\u0026rdquo;), with a cutoff of 75 years showed no notable difference in IPSS between age groups.[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] Previous research on Aquablation has demonstrated comparable reductions in IPSS and QoL for patients stratified by age with a cutoff at 65, and our findings now show similar results for patients aged 80 and older, and those younger than 80.[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] However, it should not be overlooked that while both younger men and octogenarians demonstrated significant improvements, men\u0026thinsp;\u0026ge;\u0026thinsp;80 years old had higher post-operative IPSS values at some timepoints. These findings could be due to bias or missing data, or it could suggest that while octogenarians and nonagenarians benefit from BPH surgery, they may not show the same degree of improvement. This could be related to declining detrusor function with age or may be related to a lack of bladder plasticity among older men.[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eOther studies have also demonstrated a similar trend with regards to voiding parameters between older and younger patients. Our results from the ICARUS database show that despite there being significantly higher baseline Qmax in younger patients, both age groups demonstrated a similar improvement in Qmax and reduction in PVR postoperatively. Previous studies evaluating patients undergoing laser enucleation demonstrated that there is a comparable improvement in PVR and Qmax across patients older and younger than 70 years old.[\u003cspan additionalcitationids=\"CR19 CR20 CR21\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] In our study, we have extended this analysis to Aquablation, with an age cutoff of 80, showing comparable voiding outcomes between those aged 80 and older and those younger than 80.\u003c/p\u003e \u003cp\u003eThere is a paucity of data that directly compare Aquablation with other commonly used surgical methods such as laser enucleation or TURP in terms of IPSS and QoL improvements not only in general but also across different age groups.[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] While Aquablation has shown encouraging outcomes in this population, direct comparison of Aquablation with other modalities such as HoLEP and TURP, especially regarding age-specific results, has yet to be studied.\u003c/p\u003e \u003cp\u003eJust as with patient-reported outcomes, more surgical trials are needed to further evaluate how Aquablation compares to other commonly used surgical approaches in terms of functional outcomes.\u003c/p\u003e \u003cp\u003eMen\u0026thinsp;\u0026ge;\u0026thinsp;80 years old undergoing Aquablation had significantly higher rates of takeback for cystoscopy or clot evacuation, blood transfusions, and 30-day readmissions. Older men in our study were also more likely to be in urinary retention, and in the ICARUS database, both older age (as a continuous variable) and presence of urinary retention requiring catheterization were independently associated with a composite bleeding complication outcome. These findings align with anticipated surgical risks in older patients. Of note, older men were also more likely to be on anticoagulation, but complete anticoagulation data was missing in a large proportion of the patients, so this factor was excluded from multivariate analysis. One study showed comparable postoperative bleeding outcomes after Aquablation for men on antithrombotic therapy, however this study only included 41 patients, and therefore may be underpowered.[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] For elderly patients, surgical risk is a major concern, particularly due to frailty. Frailty increases the risk of surgical complications, prolonged recovery, and poorer outcomes. Reduced physiological reserves, impaired healing, and comorbidities like cardiovascular disease make surgery riskier. Minimizing operative stress is critical in this population.[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] A measure of frailty, and not just numerical biological age, could also provide additional risk stratification.[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eWhile the study provides insights into Aquablation for older adults, it has several limitations. Retrospective design introduces selection bias (selecting patients deemed suitable by surgeons and including those from high-volume centers) and data incompleteness, limiting generalizability and conclusions on causality. Although the study was also conducted in high-volume centers, differences in individual surgeon experience, variations in Aquablation techniques and the overall learning curve, albeit small, were not accounted for.[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e] With regards to the follow-up period, limiting ourselves to a 24-month period restricts the ability to evaluate long-term outcomes and late complications or retreatments. Additionally, the lack of control group limits comparisons with other BPH treatments. The cohort of patients\u0026thinsp;\u0026ge;\u0026thinsp;80 years old and above is relatively small (N\u0026thinsp;=\u0026thinsp;206), which may reduce statistical power for detecting differences in infrequent outcomes but is comparable to other published series of other modalities in the literature. Finally, use of a standardized patient-reported outcome measure for ejaculatory function was not standardized in ICARUS and should be evaluated in the future. These limitations underscore the need for prospective, randomized trials with longer follow-up and comparison to other modalities to validate these findings in a wider range of clinical contexts.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn this international, multicenter retrospective study, Aquablation demonstrated comparable improvements in IPSS, QoL, PVR, and Qmax between \u0026ge;\u0026thinsp;80 years old and those younger than 80, with improvements sustained after 2 years follow-up, with no significant changes in sexual function and no increase in surgical retreatment rates. As expected, Aquablation was associated with higher complication rates in older men, and men considering Aquablation should be counseled appropriately. As the aging population continues to grow, ensuring access to the spectrum surgical options for BPH remains an important consideration.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cu\u003eDisclosure of potential conflicts of interest:\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eJusto Quintas - Consultant Procept Biorobotics \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRodrigues \u0026ndash; Consultant Procept Biorobotics\u003c/p\u003e\n\u003cp\u003eGlaser \u0026ndash; Medical Advisory Board Emano Metrics Inc; Consultant Procept Biorobotics\u003c/p\u003e\n\u003cp\u003eHelfand-Consultant Procept Biorobotics\u003c/p\u003e\n\u003cp\u003eZorn \u0026ndash; Consultant Procept Biorobotics, Zenflow, Laborie, Boston Scientific.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors declare that there are no conflicts of interest in relation to this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eInformed consent:\u003c/u\u003e Informed consent was obtained from all participants included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eFunding:\u003c/u\u003e The authors received no funding for this work.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eCompeting interests:\u003c/u\u003e There are no competing interests to disclose.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eEthics Approval:\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was IRB approved at Endeavor Health (EH20-122).\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eConsent to Participate:\u003c/u\u003e Informed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eData Availability Statement:\u003c/u\u003e The data analyzed in this study will not be made publicly available.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eAuthors\u0026rsquo; Contribution Statement:\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eL Murad: Manuscript writing/editing, Data collection or management\u003cbr\u003e\u0026nbsp;A Hamouda: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;D Bouhadana: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;N Lee: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;I Ohana: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;J Justo Quintas: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;J Cabral: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;A Leathead: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;A Saibi: Manuscript writing/editing\u003cbr\u003e\u0026nbsp;N Corsi: Manuscript writing/editing\u003c/p\u003e\n\u003cp\u003eCecelia Chang: Data analysis\u003cbr\u003e\u0026nbsp;T Rodrigues: Manuscript writing/editing, Data collection or management\u003cbr\u003e\u0026nbsp;A P Glaser: Manuscript writing/editing, Data collection or management, Data analysis, Protocol/project development\u003cbr\u003e\u0026nbsp;B T Helfand: Manuscript writing/editing, Data collection or management, Protocol/project development\u003cbr\u003e\u0026nbsp;K C Zorn: Manuscript writing/editing, Data collection or management, Protocol/project development\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMurad L, Bouhadana D, Nguyen D-D, Chughtai B, Zorn KC, Bhojani N et al (2023) Treating LUTS in Men with Benign Prostatic Obstruction: A Review Article. 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Urology 2025:S0090-4295(24)01229-9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.urology.2024.12.038\u003c/span\u003e\u003cspan address=\"10.1016/j.urology.2024.12.038\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFlanigan RC, Reda DJ, Wasson JH, Anderson RJ, Abdellatif M, Bruskewitz RC (1998) 5-year outcome of surgical resection and watchful waiting for men with moderately symptomatic benign prostatic hyperplasia: a Department of Veterans Affairs cooperative study. 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Urology 181:112\u0026ndash;118. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.urology.2023.08.001\u003c/span\u003e\u003cspan address=\"10.1016/j.urology.2023.08.001\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeyirmendjian C, Nguyen D-D, Law KW, Nguyen A-LV, Sadri I, Arezki A et al (2023) Safety and efficacy of GreenLight PVP in octogenarians: evaluation of the Global GreenLight Group database. World J Urol. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00345-023-04334-x\u003c/span\u003e\u003cspan address=\"10.1007/s00345-023-04334-x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGodfrey-Harris M, Connor J, 1665, RECOGNISING FRAILTY IN NON-ELECTIVE GENERAL SURGICAL PATIENTS TO OPTIMISE THEIR CARE (2023) Age Ageing 52. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1093/ageing/afad104.018\u003c/span\u003e\u003cspan address=\"10.1093/ageing/afad104.018\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. :afad104.018\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEl Hajj A, Misrai V, Nasrallah AA, Labban ML, Najdi JA, Rijo E (2022) Learning curve in aquablation: an international multicenter study. World J Urol 40:773\u0026ndash;779. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00345-021-03898-w\u003c/span\u003e\u003cspan address=\"10.1007/s00345-021-03898-w\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Aquablation, Benign Prostatic Hyperplasia, BPH, Urology, Octogenarians","lastPublishedDoi":"10.21203/rs.3.rs-6239131/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6239131/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003ePurpose\u003c/b\u003e\u003c/p\u003e \u003cp\u003eAquablation is under-researched, especially in the elderly. As older patients face higher risks of surgical complications, this study aims to evaluate the safety and efficacy of Aquablation in octogenarians.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis retrospective, multi-center study includes 2,136 patients who underwent Aquablation between 2018 and 2024. Patients were divided into two cohorts, \u0026ge;\u0026thinsp;80 and \u0026lt;\u0026thinsp;80 years of age, consisting of 206 and 1930 men, respectively. Data included baseline characteristics, operative characteristics, and post-operative functional outcomes. Peri-operative events were compared.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eMen\u0026thinsp;\u0026ge;\u0026thinsp;80 had higher rates of anxiety/depression (32% vs 16%, p\u0026thinsp;=\u0026thinsp;0.0032), 5α-reductase inhibitor use (35% vs 19%, p\u0026thinsp;=\u0026thinsp;0.0009), and anticoagulation (56% vs 24%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). Mean prostate volume was similar between groups, but men\u0026thinsp;\u0026ge;\u0026thinsp;80 were less likely to have a median lobe (52% vs 63%, p\u0026thinsp;=\u0026thinsp;0.003). Both groups showed similar improvements in peak urinary flow rate, post-void residual, International Prostate Symptom Score and quality of life. Men\u0026thinsp;\u0026ge;\u0026thinsp;80 had higher rates of take-back for cystoscopy/clot evacuation (4.4% vs 1.9%, p\u0026thinsp;=\u0026thinsp;0.034), transfusions (2.9% vs 0.5%, p\u0026thinsp;=\u0026thinsp;0.003) and 30-day readmissions (4.2% vs 0.7%, p\u0026thinsp;=\u0026thinsp;0.002). Age and urinary retention were associated with a composite bleeding outcome. There were no changes in erectile function and no differences in retrograde ejaculation between groups.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis study is the first to assess Aquablation's safety and efficacy across all ages. Aquablation offers similar voiding improvements in men aged\u0026thinsp;\u0026ge;\u0026thinsp;80 as in younger men, with slightly higher perioperative risks. Thus, Aquablation should be considered for well-selected, elderly patients with significant BPH who wish to preserve sexual function.\u003c/p\u003e","manuscriptTitle":"Safety and Efficacy of Aquablation in Men 80 Years or Older: An analysis of the International Collaborative Aquablation Research Urology Society (ICARUS) Real-World database","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-15 00:09:48","doi":"10.21203/rs.3.rs-6239131/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-06-10T12:40:24+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-28T18:46:25+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"49776530374144957702782018965203339283","date":"2025-05-25T20:01:00+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"122842458533688928605645906955234916989","date":"2025-05-24T13:34:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"114159549285991982629612422455644936847","date":"2025-05-02T09:36:40+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-04T12:43:22+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"2424126091171473234389508451588338405","date":"2025-03-26T21:14:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"44768459583083380563388446009881188831","date":"2025-03-26T13:57:51+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-26T13:33:41+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-19T17:17:19+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-19T13:20:38+00:00","index":"","fulltext":""},{"type":"submitted","content":"World Journal of Urology","date":"2025-03-16T18:43:19+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"f37ba49d-e0ab-4d33-9498-6028c8f5dcfa","owner":[],"postedDate":"April 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-11-03T16:04:24+00:00","versionOfRecord":{"articleIdentity":"rs-6239131","link":"https://doi.org/10.1007/s00345-025-05855-3","journal":{"identity":"world-journal-of-urology","isVorOnly":false,"title":"World Journal of Urology"},"publishedOn":"2025-10-30 15:57:52","publishedOnDateReadable":"October 30th, 2025"},"versionCreatedAt":"2025-04-15 00:09:48","video":"","vorDoi":"10.1007/s00345-025-05855-3","vorDoiUrl":"https://doi.org/10.1007/s00345-025-05855-3","workflowStages":[]},"version":"v1","identity":"rs-6239131","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6239131","identity":"rs-6239131","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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