Minimally invasive laser enucleation of the prostate (MiLEP) is feasible and safe: 12-month follow-up, real-life, prospective multicenter study

Minimally invasive laser enucleation of the prostate (MiLEP) is feasible and safe: 12-month follow-up, real-life, prospective multicenter study | 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 Article Minimally invasive laser enucleation of the prostate (MiLEP) is feasible and safe: 12-month follow-up, real-life, prospective multicenter study Luca Cindolo, Marco Domenico Salvaggio, Cesare Mario Scoffone, and 7 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7401199/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Minimally invasive surgical therapies have transformed the management of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction. Holmium laser enucleation of the prostate (HoLEP) is considered the gold standard for men with bothersome LUTS. HoLEP is performed with 26Ch instruments, which can cause urethral trauma, strictures, transient incontinence. Recent miniaturised 22Ch tools (MiLEP) aim to reduce morbidity without compromising efficacy. Methods This prospective multicenter study enrolled 65 men with BPH/BPO undergoing MiLEP. Preoperative assessment included IPSS, uroflowmetry, PSA, prostate volume and urinary continence. The MiLEP were performed en-bloc with early apical release. Follow-up assessed subjective and objective outcomes together with complications and patient satisfaction. Clinical success was defined as Trifecta. Logistic regression evaluated predictors of success. Results Mean age was 68,3 years and mean operative time was 82 minutes. Mean resected tissue weight was 42,6g. No major intraoperative complications occurred; median catheterisation and hospital stay were 2 and 2 days, respectively. Overall complication rate was 18,4%, mostly Clavien–Dindo grade I–II. Late complications were urethral stricture in 4,6% and persistent stress incontinence in 1,5%. At 12months, mean IPSS, IPSS QoL, Qmax, PSA significantly improved (all p < 0,001). Overall satisfaction was very high (97% “much or very much improved”). Trifecta was achieved in 61,5% of cases. Logistic regression identified lower pre operative Qmax as the only predictor of Trifecta achievement; prostate volume, age and resected tissue weight were not significant. Conclusions MiLEP is a safe and effective alternative to conventional HoLEP. Significant improvements in symptom scores, flow rate and PSA were sustained at 12 months with low morbidity and high continence preservation. These findings suggest that MiLEP may expand the benefits of enucleation to patients who might otherwise face higher complication risks. Larger trials and longer follow up are needed to confirm our data. Health sciences/Medical research Health sciences/Diseases/Urogenital diseases Health sciences/Medical research/Outcomes research Figures Figure 1 Introduction Holmium Laser Enucleation of the Prostate (HoLEP) is a gold-standard therapy for Lower urinary tracts symptoms (LUTS) related to benign prostatic hyperplasia (BPH) with obstruction (BPO), offering long-term efficacy and safety ( 1 – 2 ). The indications for this treatment have been recently widened to the treatment of recurrent LUTS/BPO, concomitant bladder stone, and in presence of prostate cancer ( 3 – 4 ). Several approaches have been used to remove the whole adenoma (en bloc, two lobes, three lobes, and recently topdown technique) ( 5 – 7 ), but the calliper of the instruments was quite homogeneous in the last 30 years and across different studies being 26Ch. In different case series not negligeable urethral traumas, postoperative strictures, and transient incontinence rates have been reported ( 8 ), and these events could negatively impact on postoperative quality of life. Especially during the learning curve phase, the difficulty of this surgical technique could lead to a higher rate of unfavourable postoperative events, being a significant problem for patients and surgeons. In order to minimize postoperative complications, the use of a smaller calibre device has been hypothesized. Every effort in the reduction of endoscopes diameters should be considered in a better respect of patient’s anatomy, as happened in the endoscopic management of urinary stone diseases ( 9 ). Very recently the minimally invasive laser enucleation of the prostate (MiLEP) has been introduced thanks to introduction of specific thin resectoscopes ( 10 ). Only small series have been published so far showing a reduced incidence of urethral strictures and transient urinary incontinence ( 10 – 15 ). However, there are sparse and inhomogeneous data in the literature regarding MiLEP with short term outcomes reported. This study evaluates the 12month follow-up in a multicenter cohort of patients treated with MiLEP in four centers using a standardized technique. Methods We prospectively enrolled men presenting LUTS related to BPH/BPO and already candidate for HoLEP. Preoperative evaluations included clinical and laboratory data collection, International Prostate Symptom Score (IPSS), uroflowmetry, prostate volume and post-void residual (PVR) by suprapubic ultrasound, serum total PSA, and urinary continence. Patients were considered continent if they did not require the use of at least one pad/day. Data of all patients consecutively treated with MiLEP were anonymized and recorded in the study after ethical committee approval (350/2021/OSS/ESTMO of “Comitato Etico dell’Area Vasta Emilia Nord”, Italy, 07/09/2021). Each patient gave written informed consent for data collection and to the surgical technique. The study was performed in accordance with the Declaration of Helsinki. Exclusion criteria were: IPSS < 7, previous urogenital surgery, urothelial carcinoma of the bladder, previous colorectal or spinal surgery, neurological disorders with urinary symptoms, prior radiotherapy or chemotherapy. Surgical Procedure: All procedures were performed under spinal anaesthesia with the patient in the lithotomy position using holmium:YAG laser (settings: enucleation energy 1.8-2J/30-50Hz; coagulation 1.2J/40Hz). The use of antibiotics and the management of antiaggregants/anticoagulants have been done according to the individual center protocols. The enucleation technique was the en-bloc with early apical sphincter release (EAR), as already described ( 10 , 16 ). Two 22Ch continuous-flow resectoscopes were used depending on the center availability: RZ-Medizintechnik® GmbH (Tuttlingen, Germany) and EndoMed Systems GmbH (Ravensburg, Germany), both equipped with a compatible working element and a 550µm laser fiber. Prostatic tissue was morcellated using a 22Ch fiberoptic Morcescope (RZ-Medizintechnik®) or a 22Ch fiberoptic mininephroscope (EndoMed Systems). The two sets have exactly the same outer diameter and the same mechanical features. The Piranha® morcellator (Richard Wolf, Knittlingen, Germany) was used at 1Hz and 750rpm, using 2 saline solution inflows. All technical problems encountered during the procedures have been collected. The tissue fragments were weighted and sent for pathological evaluation. At the end of the procedure a three-way 22Ch Dufour catheter was left with gentle bladder irrigation for 24 hours. The patients were then discharged when the clinical conditions made it possible without a catheter. Follow-up and Outcome Measures Patients were evaluated postoperatively at 1, 6, and 12 months. Patient satisfaction was recorded at 12 months using the validated Patient Global Impression of Improvement (PGI-I scale) ( 17 ). Complications were collected and classified as early (within 30 post-operative days) or late (after 90 days). Early complications were classified according to Clavien–Dindo classification ( 18 – 19 ). Late complications as urethral strictures or incontinence or reintervention were collected. Statistical Analysis Continuous variables were tested for normality and are presented as mean ± standard deviation or median and ranges where appropriate. Paired t-tests were used to assess longitudinal changes in IPSS, Qmax, and PSA from baseline to 12 months. Clinical success was defined as “Trifecta” and it was defined as the contemporary presence of: a) no postoperative complications within the first postoperative month; b) 3-months postoperative Qmax > 15ml/s and c) no urinary incontinence at 3-month evaluation. Logistic regression analyses (univariate and multivariate) were performed to identify independent predictors of clinical success. A p-value < 0.05 was considered statistically significant. Patients were stratified into three classes according PGI-I scale: 1–3 = satisfied/very satisfied, 4 = no changes, 5–7 = not satisfied. A binary variable “Complication” was defined (≥ 1 recorded complication = 1; none = 0). A Fisher’s exact test was done after collapsing classes not satisfied + indifferent vs satisfied/very satisfied, and fitted a proportionalodds (ordinal logistic) model with satisfaction class as the outcome and Complication as the sole predictor. Results A total of 65 patients were enrolled in this study with a mean age of 68,3 years (range 50–83). Among them, 8 patients (12,3%) were catheter-dependent preoperatively due to acute urinary retention. Table 1 shows the preoperatively characteristics of the patient’s population. Table 1 Descriptive pre-operative characteristics of the study cohort Overall (n = 65) Age (years) Median (IQR) 69,2 (50,0, 82.0) Prostate volume (cc) Median (IQR) 79 (65–100) PSA (ng/ml) Mean (SD) 3,7 ( 2 , 4 ) PVR (ml) Mean (SD) 119 (163) Q max (ml/sec) Mean (SD) 10,26 ( 3 ) IPSS Mean (SD) 20,31 ( 5 , 5 ) IPSS QoL (mean) 3,8 ( 1 ) Pre-operative anticoagulants - None 49 (75%) - Antiplatelet 13 (20%) - Anticoagulant 3 (5%) BPH Therapy - Alpha-blockers 34 (53%) - Combination therapy 16 (25%) - None/Phytotherapy 13 (20%) − 5-ARIs 3 (2%) History of indwelling catheter 8 (12,3%) The median operative time was 82min (IQR, 40–134) and the mean resected prostate tissue was 42,6gr (range 21–86). All specimens revealed benign prostatic hyperplasia with different degrees of inflammation, but one case revealed an incidental pT1a adenocarcinoma of the prostate Gleason score 3 + 3. Intraoperatively, because of a poor quality of the vision the thin Morcescope/Nephroscope was removed and a 26Ch standard sheath with standard nephroscope was used for morcellation in 5 cases. No breakages of the resectoscopes or optics occurred. In 6 cases a bipolar coagulation has been done to ensure optimal haemostasis before morcellation. The median catheterization time and length of stay were 2 and 2 days, respectively. No major intraoperative complications occurred. No patients experienced hematuria requiring reintervention nor blood transfusion. The mean hemoglobin drop was 0.7 g/dl. All patients completed the 12-month follow-up. The overall complication rate was 18,4% ( n = 12), with the vast majority of complications being minor (Clavien Dindo grade I and II) and no severe complications (Clavien Dindo grade III to V) occurring. CDC grade I complications were urinary retention and prolonged gross hematuria, CDC grade II complications were mainly urinary tract infections, chronic obstructive pulmonary disease exacerbation, subileus (Table 2 ). Postoperative urinary incontinence and stenotic complications are described in Table 2 . Table 2 Descriptive early and late complications Early ( 90 days) Fever > 38°C (%) 4 (6%) - Urinary Retention (%) 4 (6%) - Prolonged Gross Hematuria (%) 3 (4%) - UTI (%) 5 (7%) - Subileus (%) 1 (1,5%) - COPD exacerbation 1 (1,5%) Urgency 10 (6,5%) 3 (4,6%) Urge incontinence (%) 5 (7,5%) 2 (3%) Stress incontinence 8 (12,3%) 4 (6%) Urethral Stricture - 3 (4,6%) Bladder Neck Contracture - - The mean IPSS and IPSS QoL significantly improved from 20,31 (SD = 5,5) and 3,8 preoperatively to 7,63 (SD = 4,0) and 1,3 at 12 months (p < 0,001), respectively. Urinary flow rate and PVR showed a significant improvement, from a baseline average of 10,26ml/s (SD = 3,0) and 119ml (SD = 163) to 20,27ml/s (SD = 5,2) and 18ml (SD = 19) postoperatively (p < 0,001), respectively. Prostate-specific antigen (PSA) levels also decreased significantly, from 3,7ng/ml (SD = 2,4) to 1,41ng/ml (SD = 1,2) at 12 months (p < 0,001) (Fig. 1 ) At 12-month follow-up consultation the patient satisfaction showed high levels of perceived benefit: 97% of patients scored much/very much improved. At the same time point, 3 patients (4,6%) had complained urethral complications requiring endoscopic treatment (2 bulbar strictures, 1 meatal stricture). Urinary stress incontinence requiring pad use was observed in 8 patients (12,3%) at 1 month, 4 patients (6%) at 3 months, and persisted in 1 patient (1,5%) at 12 months. No cases of bladder neck contracture were observed (Table 2 ). Overall, complications were 20% and did not independently predict patientreported satisfaction in this cohort (Fisher’s exact test no significant association between complications and dissatisfaction (p = 0,44)). Trifecta was achieved in 61,5% of the cases. Logistic regression analysis revealed a low preoperative Qmax was identified as good predictor, whereas neither prostate volume, age, nor resected tissue amount were statistically associated with Trifecta achievement in multivariate models (Table 3 ). Table 3 Univariate and Multivariate Analyses Univariate Analysis Multivariate Analysis Variable OR (univariate) p-value OR (multivariate) p-value Age 0.0261 0.4828 0.0069 0.8748 Prostate Volume 0.0227 0.0830 0.0244 0.3171 Resected tissue 0.0219 0.2121 -0.0101 0.7613 Preop Qmax -0.4286 0.0072 -0.4161 0.0127 Discussion In the evolving landscape of surgical innovation, technological advances continue to drive the development of less invasive approaches across all specialties. Minimally invasive surgical therapies (MISTs) have transformed the management of benign prostatic hyperplasia (BPH) by providing effective relief of obstruction with lower morbidity than traditional procedures ( 20 – 21 ). Laser-based techniques such as HoLEP have emerged as a surgical standard. Large randomized trials comparing HoLEP with transurethral resection and open/robotic prostatectomy have shown superior improvements in urinary flow and symptom scores, shorter catheterization and hospital stay, and fewer serious complications. HoLEP can enucleate glands larger than 100g with results comparable to open surgery but markedly lower morbidity ( 22 ). These data have led many guidelines to position HoLEP as the reference surgical option for men with BPH ( 1 – 2 ). Despite its durability, conventional HoLEP is typically performed with 26Ch resectoscopes. The larger sheath and steep learning curve have been hypothesized as possible cause of urethral trauma, transient incontinence and postoperative strictures ( 23 – 24 ). To limits the risk of these complications, some miniaturized instruments have been proposed. A prospective study ( 12 ) comparing 22Ch and 26Ch sheaths demonstrated that enucleation with the thinner resectoscope was independently associated with a lower rate of transient urinary leakage and provided better early improvements in IPSS and quality of life. Another retrospective series found no significant difference in the incidence of urethral strictures or bladder neck contracture but documented less blood loss with a 26Ch sheath compared with 28Ch ( 25 ). In a propensity score analysis highlighted as the adoption of thinner scopes allowed a better maintenance of body core temperature and reduction in the amount of irrigation, with a clear benefit in terms of overall surgical safety ( 11 ). Our series confirms that the use of a 22Ch resectoscope combined with enbloc adenoma dissection and early apical release preserves continence and limits urethral trauma: three patients (4,6%) developed a urethral stricture requiring endoscopic treatment, and only 1 patient (1,5%) complained stress urinary incontinence requiring pads persistent at 12 months. The enbloc technique itself appears to enhance anatomical preservation. By creating a single continuous incision with early division of the apex, the surgeon can maintain the surgical plane, spare the external sphincter’s mucosa and achieve a gentle enucleation, especially using the "closed cavity enucleation" (without communication to the bladder): the small groove between the adenoma and the capsule allows excellent fluid turnover, washing out any blood and maintaining an optimal vision ( 10 ). These advantages may explain the high continence rates observed in our cohort: padfree status was achieved in 95,4%, 96,9% and 98,5% of patients at 3, 6 and 12 months, respectively. Our results also highlight excellent functional outcomes. The statistically significant changes in IPSS and IPSS qualityoflife score, in maximum urinary flow rate and PSA mirrored those reported in large HoLEP series and confirmed that miniaturization does not compromise efficacy, as already recently reported by Schmidt ( 14 ) and Rein ( 15 ). Perioperative morbidity was low. No patients required transfusion or reoperation, the mean hemoglobin drop was 0,7 g/dL, and the median catheterization and hospitalization time was 2 days. Early complications occurred in 18,4% of patients and were mostly minor (Clavien–Dindo grades I–II). Late complications were rare and included three urethral strictures and persistent stress incontinence in one patient. Logistic regression analysis did not identify predictors over the preoperative low Qmax; nonetheless, 61,5% of patients met the Trifecta definition of success and 97% reported they were very much or much improved at 12 months and confirm the data already available in the literature after standard HoLEP ( 26 ). From a technical point of view some aspects should be acknowledged. The use of the continuous flow resectoscopes with rotatable inner sheath, and 2,9mm rod lens scopes demonstrated great mechanical performances without any breakage or kinking reported. Moreover, the use of fiberoptic Morcescope or Mininephroscope, in a very limited percentage of cases, required a “conversion” to 26Ch standard sheath because of limited image size and a vision quality. In case of bipolar coagulation, the use of dedicated working elements and small loops allowed an optimal hemostasis in all cases. Strengths of our study include the prospective collection of multicenter data and complete 12-month follow-up. However, the absence of a direct comparator arm, modest sample size and reliance on two different miniature resectoscopes limit generalizability. Longer-term follow-up is needed to assess durability beyond one year. Our data suggest that MiLEP represents one of the possible tailored intervention that balances factors such as efficacy, morbidity, rapid recovery, and anatomy preservation. For that we think that referral centres will be the ideal place where manage challenging cases, with enhanced surgical results ( 27 ). This multicentre study demonstrates that MiLEP is a safe and effective surgical option for men with BPHrelated lower urinary tract symptoms. Significant improvements in symptom scores, urinary flow and PSA levels were maintained at 12months, and perioperative morbidity was low. The use of smallerdiameter instruments appears to reduce urethral trauma and preserve continence without sacrificing enucleation efficacy. These advantages, together with short catheterization and hospitalization times, make MiLEP an attractive minimally invasive alternative to conventional HoLEP, particularly for patients at higher risk of urethral trauma. Larger randomized studies with longer follow-up are warranted to confirm the long-term durability of these outcomes and establish the role of MiLEP as a standard of care. Declarations Conflict of Interest: All authors declare that they have no competing financial interests in relation to the work described. Ethics approval and consent to participate : see methods section Funding: This study was a spontaneous one, without anyfunding. Authorship: LC, GF, MDS :study design and writing of the draft; MDS, CMS, CMC, LB RC, FB data collection; LC, MDS, LO: statistical analysis and manuscript supervision; LC, CMS, GF, IGK: critical overview, supervision. All authors read and approved the final version of the manuscript. References Gravas S, Malde S, Cornu JN, Drake MJ, Gratzke C, Bachmann A, et al. From BPH to male LUTS: a 20 year journey of the EAU guidelines. Prostate Cancer Prostatic Dis 27, 48–53 (2024) Grosso AA, Amparore D, Di Maida F, de Cillis S, Cocci A, Di Dio M, et al. Comparison of perioperative and short-terms outcomes of en-bloc Holmium laser enucleation of the prostate (HoLEP) and robot-assisted simple prostatectomy: a propensity-score matching analysis. Prostate Cancer Prostatic Dis 27 (3):478-484 (2024) Tamalunas A, Keller P, Schott M, May M, Bannowsky A, Ahmed M, et al. 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Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of "Trifecta". World J Mens Health ;41(3):603-611 (2023) Secco S, Cindolo L. Do We Need Referral Centers for Benign Prostatic Hyperplasia that Offer Expertise in More Options? Yes, with a SMART (Specialized Medical Assessment for Right Treatment) Approach. Eur Urol Focus 26:S2405-4569(25)00067-7 (2025) Additional Declarations There is NO conflict of interest to disclose. Cite Share Download PDF Status: Posted Version 1 posted 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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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-7401199","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":506548286,"identity":"74857524-ce0d-4a07-afc0-ee5cde2b2258","order_by":0,"name":"Luca Cindolo","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6klEQVRIiWNgGAWjYBACPjBpwMDYwM7A+ADIYGBjZ2wAieAEbHAtzAzMBmAtzGAtuPWwQWmQFjYJMJMZagpOLRLJDz/8KLgj28/MfKyap+CeXR8zc+MDhoI/eLSkGUv2GDwzntnMlnabx6A4uY2ZsdkAr8MkchikGQwOJ244zGN2c4ZBQjLQL20SBLQw/4ZpKSRWCxvcFoYPBgl2hLXwPDOz7DE4DPJLsgRQSwIbyC8JBsY4tfCzJz++8ePPYdl+9uaDHxL+JNjLt7c/fPDhjxxOLRggsQFEJhCvgYHBnhTFo2AUjIJRMDIAAE1KRjUUnhUEAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-0712-2719","institution":"Villa Stuart Private Hospital","correspondingAuthor":true,"prefix":"","firstName":"Luca","middleName":"","lastName":"Cindolo","suffix":""},{"id":506548287,"identity":"e55157d0-5d3a-4ebc-b7e9-88c3af688035","order_by":1,"name":"Marco Domenico Salvaggio","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Marco","middleName":"Domenico","lastName":"Salvaggio","suffix":""},{"id":506548288,"identity":"4f2504c5-7ad1-4dc3-8ef6-22c42051a5d5","order_by":2,"name":"Cesare Mario Scoffone","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Cesare","middleName":"Mario","lastName":"Scoffone","suffix":""},{"id":506548289,"identity":"d298d802-6a07-4934-b258-40393a544fef","order_by":3,"name":"Cecilia Cracco","email":"","orcid":"","institution":"Ospedale Cottolengo di Torino, S.C. Urologia","correspondingAuthor":false,"prefix":"","firstName":"Cecilia","middleName":"","lastName":"Cracco","suffix":""},{"id":506548290,"identity":"1afe8365-5fa2-4490-9417-3fecf3c4cafa","order_by":4,"name":"Ioannis Goumas Kartalas","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Ioannis","middleName":"Goumas","lastName":"Kartalas","suffix":""},{"id":506548291,"identity":"850b2fb3-a924-4355-94d1-387ce25f651e","order_by":5,"name":"Luigi Bevilacqua","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Luigi","middleName":"","lastName":"Bevilacqua","suffix":""},{"id":506548292,"identity":"e6942499-dbbd-4692-b242-45b433e69e0d","order_by":6,"name":"Luca Orecchia","email":"","orcid":"https://orcid.org/0000-0001-8376-5380","institution":"AOU Policlinico Tor Vergata","correspondingAuthor":false,"prefix":"","firstName":"Luca","middleName":"","lastName":"Orecchia","suffix":""},{"id":506548293,"identity":"aee06f62-50d4-4d35-aece-595bdebaa105","order_by":7,"name":"roberto castelucci","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"roberto","middleName":"","lastName":"castelucci","suffix":""},{"id":506548294,"identity":"554b41ba-6427-4048-af53-02d7107d4b2d","order_by":8,"name":"Francesco Dibitetto","email":"","orcid":"https://orcid.org/0000-0003-0922-5962","institution":"Uroclinic, Casa di Cura Villa Claudia","correspondingAuthor":false,"prefix":"","firstName":"Francesco","middleName":"","lastName":"Dibitetto","suffix":""},{"id":506548295,"identity":"3841c31a-e807-43fb-9f1a-e0dda3c6c1a7","order_by":9,"name":"Giovanni Ferrari","email":"","orcid":"","institution":"Dept. of Urology, “Hesperia Hospital”, and CURE Group","correspondingAuthor":false,"prefix":"","firstName":"Giovanni","middleName":"","lastName":"Ferrari","suffix":""}],"badges":[],"createdAt":"2025-08-18 15:30:44","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7401199/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7401199/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90793800,"identity":"e52048de-dfbf-421f-b7ae-41654b8da5dd","added_by":"auto","created_at":"2025-09-08 08:39:21","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":160963,"visible":true,"origin":"","legend":"\u003cp\u003eIPSS, Qmax , PSA and IPSS-QoL variation between preoperative and 12-month follow-up\u003c/p\u003e","description":"","filename":"Fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-7401199/v1/26ace10033807c925d71edda.png"},{"id":91663550,"identity":"019784b9-8743-4cd6-9b04-c4296de68a17","added_by":"auto","created_at":"2025-09-18 23:08:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":779635,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7401199/v1/4692f847-23d3-4d39-8f06-89a4d90fce20.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"Minimally invasive laser enucleation of the prostate (MiLEP) is feasible and safe: 12-month follow-up, real-life, prospective multicenter study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eHolmium Laser Enucleation of the Prostate (HoLEP) is a gold-standard therapy for Lower urinary tracts symptoms (LUTS) related to benign prostatic hyperplasia (BPH) with obstruction (BPO), offering long-term efficacy and safety (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). The indications for this treatment have been recently widened to the treatment of recurrent LUTS/BPO, concomitant bladder stone, and in presence of prostate cancer (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eSeveral approaches have been used to remove the whole adenoma (en bloc, two lobes, three lobes, and recently topdown technique) (\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), but the calliper of the instruments was quite homogeneous in the last 30 years and across different studies being 26Ch. In different case series not negligeable urethral traumas, postoperative strictures, and transient incontinence rates have been reported (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), and these events could negatively impact on postoperative quality of life. Especially during the learning curve phase, the difficulty of this surgical technique could lead to a higher rate of unfavourable postoperative events, being a significant problem for patients and surgeons.\u003c/p\u003e\u003cp\u003eIn order to minimize postoperative complications, the use of a smaller calibre device has been hypothesized. Every effort in the reduction of endoscopes diameters should be considered in a better respect of patient\u0026rsquo;s anatomy, as happened in the endoscopic management of urinary stone diseases (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Very recently the minimally invasive laser enucleation of the prostate (MiLEP) has been introduced thanks to introduction of specific thin resectoscopes (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Only small series have been published so far showing a reduced incidence of urethral strictures and transient urinary incontinence (\u003cspan additionalcitationids=\"CR11 CR12 CR13 CR14\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). However, there are sparse and inhomogeneous data in the literature regarding MiLEP with short term outcomes reported. This study evaluates the 12month follow-up in a multicenter cohort of patients treated with MiLEP in four centers using a standardized technique.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eWe prospectively enrolled men presenting LUTS related to BPH/BPO and already candidate for HoLEP. Preoperative evaluations included clinical and laboratory data collection, International Prostate Symptom Score (IPSS), uroflowmetry, prostate volume and post-void residual (PVR) by suprapubic ultrasound, serum total PSA, and urinary continence. Patients were considered continent if they did not require the use of at least one pad/day. Data of all patients consecutively treated with MiLEP were anonymized and recorded in the study after ethical committee approval (350/2021/OSS/ESTMO of \u0026ldquo;Comitato Etico dell\u0026rsquo;Area Vasta Emilia Nord\u0026rdquo;, Italy, 07/09/2021). Each patient gave written informed consent for data collection and to the surgical technique. The study was performed in accordance with the Declaration of Helsinki. Exclusion criteria were: IPSS\u0026thinsp;\u0026lt;\u0026thinsp;7, previous urogenital surgery, urothelial carcinoma of the bladder, previous colorectal or spinal surgery, neurological disorders with urinary symptoms, prior radiotherapy or chemotherapy.\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eSurgical Procedure:\u003c/h2\u003e\u003cp\u003eAll procedures were performed under spinal anaesthesia with the patient in the lithotomy position using holmium:YAG laser (settings: enucleation energy 1.8-2J/30-50Hz; coagulation 1.2J/40Hz). The use of antibiotics and the management of antiaggregants/anticoagulants have been done according to the individual center protocols. The enucleation technique was the en-bloc with early apical sphincter release (EAR), as already described (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Two 22Ch continuous-flow resectoscopes were used depending on the center availability: RZ-Medizintechnik\u0026reg; GmbH (Tuttlingen, Germany) and EndoMed Systems GmbH (Ravensburg, Germany), both equipped with a compatible working element and a 550\u0026micro;m laser fiber. Prostatic tissue was morcellated using a 22Ch fiberoptic Morcescope (RZ-Medizintechnik\u0026reg;) or a 22Ch fiberoptic mininephroscope (EndoMed Systems). The two sets have exactly the same outer diameter and the same mechanical features. The Piranha\u0026reg; morcellator (Richard Wolf, Knittlingen, Germany) was used at 1Hz and 750rpm, using 2 saline solution inflows. All technical problems encountered during the procedures have been collected. The tissue fragments were weighted and sent for pathological evaluation. At the end of the procedure a three-way 22Ch Dufour catheter was left with gentle bladder irrigation for 24 hours. The patients were then discharged when the clinical conditions made it possible without a catheter.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eFollow-up and Outcome Measures\u003c/h3\u003e\n\u003cp\u003ePatients were evaluated postoperatively at 1, 6, and 12 months. Patient satisfaction was recorded at 12 months using the validated Patient Global Impression of Improvement (PGI-I scale) (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Complications were collected and classified as early (within 30 post-operative days) or late (after 90 days). Early complications were classified according to Clavien\u0026ndash;Dindo classification (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). Late complications as urethral strictures or incontinence or reintervention were collected.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStatistical Analysis\u003c/b\u003e Continuous variables were tested for normality and are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or median and ranges where appropriate. Paired t-tests were used to assess longitudinal changes in IPSS, Qmax, and PSA from baseline to 12 months. Clinical success was defined as \u0026ldquo;Trifecta\u0026rdquo; and it was defined as the contemporary presence of: a) no postoperative complications within the first postoperative month; b) 3-months postoperative Qmax\u0026thinsp;\u0026gt;\u0026thinsp;15ml/s and c) no urinary incontinence at 3-month evaluation. Logistic regression analyses (univariate and multivariate) were performed to identify independent predictors of clinical success. A p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant. Patients were stratified into three classes according PGI-I scale: 1\u0026ndash;3\u0026thinsp;=\u0026thinsp;satisfied/very satisfied, 4\u0026thinsp;=\u0026thinsp;no changes, 5\u0026ndash;7\u0026thinsp;=\u0026thinsp;not satisfied. A binary variable \u0026ldquo;Complication\u0026rdquo; was defined (\u0026ge;\u0026thinsp;1 recorded complication\u0026thinsp;=\u0026thinsp;1; none\u0026thinsp;=\u0026thinsp;0). A Fisher\u0026rsquo;s exact test was done after collapsing classes not satisfied\u0026thinsp;+\u0026thinsp;indifferent vs satisfied/very satisfied, and fitted a proportionalodds (ordinal logistic) model with satisfaction class as the outcome and \u003cem\u003eComplication\u003c/em\u003e as the sole predictor.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 65 patients were enrolled in this study with a mean age of 68,3 years (range 50\u0026ndash;83). Among them, 8 patients (12,3%) were catheter-dependent preoperatively due to acute urinary retention. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows the preoperatively characteristics of the patient\u0026rsquo;s population.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u003cem\u003eDescriptive pre-operative characteristics of the study cohort\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOverall (n\u0026thinsp;=\u0026thinsp;65)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAge (years)\u003c/b\u003e Median (IQR)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e69,2 (50,0, 82.0)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eProstate volume (cc)\u003c/b\u003e Median (IQR)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e79 (65\u0026ndash;100)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePSA (ng/ml)\u003c/b\u003e Mean (SD)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3,7 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePVR (ml)\u003c/b\u003e Mean (SD)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e119 (163)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eQ max (ml/sec)\u003c/b\u003e Mean (SD)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10,26 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIPSS\u003c/b\u003e Mean (SD)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e20,31 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eIPSS QoL (mean)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3,8 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePre-operative anticoagulants\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- None\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e49 (75%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- Antiplatelet\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (20%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- Anticoagulant\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eBPH Therapy\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- Alpha-blockers\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e34 (53%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- Combination therapy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e16 (25%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- None/Phytotherapy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (20%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026minus;\u0026thinsp;5-ARIs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eHistory of indwelling catheter\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (12,3%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe median operative time was 82min (IQR, 40\u0026ndash;134) and the mean resected prostate tissue was 42,6gr (range 21\u0026ndash;86). All specimens revealed benign prostatic hyperplasia with different degrees of inflammation, but one case revealed an incidental pT1a adenocarcinoma of the prostate Gleason score 3\u0026thinsp;+\u0026thinsp;3.\u003c/p\u003e\u003cp\u003eIntraoperatively, because of a poor quality of the vision the thin Morcescope/Nephroscope was removed and a 26Ch standard sheath with standard nephroscope was used for morcellation in 5 cases. No breakages of the resectoscopes or optics occurred. In 6 cases a bipolar coagulation has been done to ensure optimal haemostasis before morcellation.\u003c/p\u003e\u003cp\u003eThe median catheterization time and length of stay were 2 and 2 days, respectively.\u003c/p\u003e\u003cp\u003eNo major intraoperative complications occurred. No patients experienced hematuria requiring reintervention nor blood transfusion. The mean hemoglobin drop was 0.7 g/dl. All patients completed the 12-month follow-up. The overall complication rate was 18,4% (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;12), with the vast majority of complications being minor (Clavien Dindo grade I and II) and no severe complications (Clavien Dindo grade III to V) occurring. CDC grade I complications were urinary retention and prolonged gross hematuria, CDC grade II complications were mainly urinary tract infections, chronic obstructive pulmonary disease exacerbation, subileus (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Postoperative urinary incontinence and stenotic complications are described in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u003cem\u003eDescriptive early and late complications\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eEarly\u003c/p\u003e\u003cp\u003e(\u0026lt;\u0026thinsp;30 days)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eLate\u003c/p\u003e\u003cp\u003e(\u0026gt;\u0026thinsp;90 days)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFever\u0026thinsp;\u0026gt;\u0026thinsp;38\u0026deg;C (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUrinary Retention (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProlonged Gross Hematuria (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUTI (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSubileus (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (1,5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCOPD exacerbation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (1,5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eUrgency\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10 (6,5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (4,6%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUrge incontinence (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (7,5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (3%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStress incontinence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (12,3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (6%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUrethral Stricture\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (4,6%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBladder Neck Contracture\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe mean IPSS and IPSS QoL significantly improved from 20,31 (SD\u0026thinsp;=\u0026thinsp;5,5) and 3,8 preoperatively to 7,63 (SD\u0026thinsp;=\u0026thinsp;4,0) and 1,3 at 12 months (p\u0026thinsp;\u0026lt;\u0026thinsp;0,001), respectively. Urinary flow rate and PVR showed a significant improvement, from a baseline average of 10,26ml/s (SD\u0026thinsp;=\u0026thinsp;3,0) and 119ml (SD\u0026thinsp;=\u0026thinsp;163) to 20,27ml/s (SD\u0026thinsp;=\u0026thinsp;5,2) and 18ml (SD\u0026thinsp;=\u0026thinsp;19) postoperatively (p\u0026thinsp;\u0026lt;\u0026thinsp;0,001), respectively. Prostate-specific antigen (PSA) levels also decreased significantly, from 3,7ng/ml (SD\u0026thinsp;=\u0026thinsp;2,4) to 1,41ng/ml (SD\u0026thinsp;=\u0026thinsp;1,2) at 12 months (p\u0026thinsp;\u0026lt;\u0026thinsp;0,001) (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eAt 12-month follow-up consultation the patient satisfaction showed high levels of perceived benefit: 97% of patients scored much/very much improved. At the same time point, 3 patients (4,6%) had complained urethral complications requiring endoscopic treatment (2 bulbar strictures, 1 meatal stricture). Urinary stress incontinence requiring pad use was observed in 8 patients (12,3%) at 1 month, 4 patients (6%) at 3 months, and persisted in 1 patient (1,5%) at 12 months. No cases of bladder neck contracture were observed (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Overall, complications were 20% and did not independently predict patientreported satisfaction in this cohort (Fisher\u0026rsquo;s exact test no significant association between complications and dissatisfaction (p\u0026thinsp;=\u0026thinsp;0,44)). Trifecta was achieved in 61,5% of the cases. Logistic regression analysis revealed a low preoperative Qmax was identified as good predictor, whereas neither prostate volume, age, nor resected tissue amount were statistically associated with Trifecta achievement in multivariate models (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u003cem\u003eUnivariate and Multivariate Analyses\u003c/em\u003e \u003cb\u003eUnivariate Analysis Multivariate Analysis\u003c/b\u003e\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOR (univariate)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eOR (multivariate)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.0261\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.4828\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.0069\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.8748\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProstate Volume\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.0227\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.0830\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.0244\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.3171\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eResected tissue\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.0219\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.2121\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e-0.0101\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.7613\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePreop Qmax\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e-0.4286\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.0072\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e-0.4161\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.0127\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn the evolving landscape of surgical innovation, technological advances continue to drive the development of less invasive approaches across all specialties. Minimally invasive surgical therapies (MISTs) have transformed the management of benign prostatic hyperplasia (BPH) by providing effective relief of obstruction with lower morbidity than traditional procedures (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Laser-based techniques such as HoLEP have emerged as a surgical standard. Large randomized trials comparing HoLEP with transurethral resection and open/robotic prostatectomy have shown superior improvements in urinary flow and symptom scores, shorter catheterization and hospital stay, and fewer serious complications. HoLEP can enucleate glands larger than 100g with results comparable to open surgery but markedly lower morbidity (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). These data have led many guidelines to position HoLEP as the reference surgical option for men with BPH (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eDespite its durability, conventional HoLEP is typically performed with 26Ch resectoscopes. The larger sheath and steep learning curve have been hypothesized as possible cause of urethral trauma, transient incontinence and postoperative strictures (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). To limits the risk of these complications, some miniaturized instruments have been proposed. A prospective study (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) comparing 22Ch and 26Ch sheaths demonstrated that enucleation with the thinner resectoscope was independently associated with a lower rate of transient urinary leakage and provided better early improvements in IPSS and quality of life. Another retrospective series found no significant difference in the incidence of urethral strictures or bladder neck contracture but documented less blood loss with a 26Ch sheath compared with 28Ch (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). In a propensity score analysis highlighted as the adoption of thinner scopes allowed a better maintenance of body core temperature and reduction in the amount of irrigation, with a clear benefit in terms of overall surgical safety (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Our series confirms that the use of a 22Ch resectoscope combined with enbloc adenoma dissection and early apical release preserves continence and limits urethral trauma: three patients (4,6%) developed a urethral stricture requiring endoscopic treatment, and only 1 patient (1,5%) complained stress urinary incontinence requiring pads persistent at 12 months.\u003c/p\u003e\u003cp\u003eThe enbloc technique itself appears to enhance anatomical preservation. By creating a single continuous incision with early division of the apex, the surgeon can maintain the surgical plane, spare the external sphincter\u0026rsquo;s mucosa and achieve a gentle enucleation, especially using the \"closed cavity enucleation\" (without communication to the bladder): the small groove between the adenoma and the capsule allows excellent fluid turnover, washing out any blood and maintaining an optimal vision (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). These advantages may explain the high continence rates observed in our cohort: padfree status was achieved in 95,4%, 96,9% and 98,5% of patients at 3, 6 and 12 months, respectively. Our results also highlight excellent functional outcomes. The statistically significant changes in IPSS and IPSS qualityoflife score, in maximum urinary flow rate and PSA mirrored those reported in large HoLEP series and confirmed that miniaturization does not compromise efficacy, as already recently reported by Schmidt (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) and Rein (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e\u003cp\u003ePerioperative morbidity was low. No patients required transfusion or reoperation, the mean hemoglobin drop was 0,7 g/dL, and the median catheterization and hospitalization time was 2 days. Early complications occurred in 18,4% of patients and were mostly minor (Clavien\u0026ndash;Dindo grades I\u0026ndash;II). Late complications were rare and included three urethral strictures and persistent stress incontinence in one patient. Logistic regression analysis did not identify predictors over the preoperative low Qmax; nonetheless, 61,5% of patients met the Trifecta definition of success and 97% reported they were very much or much improved at 12 months and confirm the data already available in the literature after standard HoLEP (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eFrom a technical point of view some aspects should be acknowledged. The use of the continuous flow resectoscopes with rotatable inner sheath, and 2,9mm rod lens scopes demonstrated great mechanical performances without any breakage or kinking reported. Moreover, the use of fiberoptic Morcescope or Mininephroscope, in a very limited percentage of cases, required a \u0026ldquo;conversion\u0026rdquo; to 26Ch standard sheath because of limited image size and a vision quality. In case of bipolar coagulation, the use of dedicated working elements and small loops allowed an optimal hemostasis in all cases.\u003c/p\u003e\u003cp\u003eStrengths of our study include the prospective collection of multicenter data and complete 12-month follow-up. However, the absence of a direct comparator arm, modest sample size and reliance on two different miniature resectoscopes limit generalizability. Longer-term follow-up is needed to assess durability beyond one year. Our data suggest that MiLEP represents one of the possible tailored intervention that balances factors such as efficacy, morbidity, rapid recovery, and anatomy preservation. For that we think that referral centres will be the ideal place where manage challenging cases, with enhanced surgical results (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThis multicentre study demonstrates that MiLEP is a safe and effective surgical option for men with BPHrelated lower urinary tract symptoms. Significant improvements in symptom scores, urinary flow and PSA levels were maintained at 12months, and perioperative morbidity was low. The use of smallerdiameter instruments appears to reduce urethral trauma and preserve continence without sacrificing enucleation efficacy. These advantages, together with short catheterization and hospitalization times, make MiLEP an attractive minimally invasive alternative to conventional HoLEP, particularly for patients at higher risk of urethral trauma. Larger randomized studies with longer follow-up are warranted to confirm the long-term durability of these outcomes and establish the role of MiLEP as a standard of care.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflict of Interest:\u0026nbsp;\u003c/strong\u003e All authors declare that they have no competing financial interests in relation to the work described.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e: see methods section\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThis study was a spontaneous one, without anyfunding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthorship:\u0026nbsp;\u003c/strong\u003eLC, GF, MDS :study design and writing of the draft; MDS, CMS, CMC, LB RC, FB data collection; LC, MDS, LO: statistical analysis and manuscript supervision; LC, CMS, GF, IGK: critical overview, supervision.\u003c/p\u003e\n\u003cp\u003eAll authors read and approved the final version of the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eGravas S, Malde S, Cornu JN, Drake MJ, Gratzke C, Bachmann A, et al. From BPH to male LUTS: a 20 year journey of the EAU guidelines. \u003cem\u003eProstate Cancer Prostatic Dis\u003c/em\u003e 27, 48\u0026ndash;53 (2024)\u003c/li\u003e\n \u003cli\u003eGrosso AA, Amparore D, Di Maida F, de Cillis S, Cocci A, Di Dio M, et al.\u0026nbsp;Comparison of perioperative and short-terms outcomes of en-bloc Holmium laser enucleation of the prostate (HoLEP) and robot-assisted simple prostatectomy: a propensity-score matching analysis. Prostate Cancer Prostatic Dis \u003cstrong\u003e27\u003c/strong\u003e(3):478-484 (2024)\u003c/li\u003e\n \u003cli\u003eTamalunas A, Keller P, Schott M, May M, Bannowsky A, Ahmed M, et al. 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Top-down holmium laser enucleation of the prostate (HoLEP) versus traditional HoLEP for the treatment of benign prostatic hyperplasia (BPH): 1-year outcomes of a randomized controlled trial. \u003cem\u003eProstate Cancer Prostatic Dis\u003c/em\u003e 27, 462\u0026ndash;468 (2024)\u003c/li\u003e\n \u003cli\u003eOrtner G, Pang KH, Yuan Y, Herrmann TRW, Biyani CS, Tokas T. Peri- and post-operative outcomes, complications, and functional results amongst different modifications of endoscopic enucleation of the prostate (EEP): a systematic review and meta-analysis.\u0026nbsp;\u003cem\u003eWorld J Urol\u003c/em\u003e 41, 969\u0026ndash;980 (2023)\u003c/li\u003e\n \u003cli\u003eVentimiglia E, Orecchia L, Bevilacqua L, Tondelli E, Oliva I, Cindolo L, et al. Anatomic endoscopic enucleation of the prostate using a novel hybrid thulium:yttrium-aluminium-garnet laser generator: surgical technique and clinical outcomes. \u003cem\u003eWorld J Urol\u003c/em\u003e 42(1):498. (2024)\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLicari LC, Bologna E, Manfredi C, Wosnitzer M, Chung DE, Kaplan SA, et al. Incidence and management of BPH surgery related urethral stricture: results from a large U.S. database.\u0026nbsp;\u003cem\u003eProstate Cancer Prostatic Dis\u003c/em\u003e 27, 537\u0026ndash;543 (2024)\u003c/li\u003e\n \u003cli\u003eGiusti G, Proietti S, Peschechera R, Taverna G, Sortino G, Cindolo L, et al. Sky is no limit for ureteroscopy: extending the indications and special circumstances.\u0026nbsp;\u003cem\u003eWorld J Urol\u003c/em\u003e 33, 257\u0026ndash;273 (2015)\u003c/li\u003e\n \u003cli\u003ede Figueiredo FCA, Teloken PE. Minimally invasive laser enucleation of the prostate (MiLEP): slim (22Ch) and ultra slim (18.5Ch) HoLEP.\u0026nbsp;\u003cem\u003eUrol Video J\u003c/em\u003e 14, 100146 (2022)\u003c/li\u003e\n \u003cli\u003eTaha T, Savin Z, Lifshitz K, Tsivian A, Zilberman DE, Ramon J, et al. Mini HoLEP (MiLEP) vs HoLEP: a propensity score matched analysis.\u0026nbsp;\u003cem\u003eWorld J Urol\u003c/em\u003e 41, 2801\u0026ndash;2807 (2023)\u003c/li\u003e\n \u003cli\u003eIbis MA, Tokatlı Z. Does the use of a small size resectoscope during enucleation prevent transient urinary leakage and urethral stricture following holmium laser enucleation of the prostate.\u0026nbsp;\u003cem\u003eLUTS\u003c/em\u003e 14, 86\u0026ndash;91 (2022)\u003c/li\u003e\n \u003cli\u003eAlves BB, Gabrich P, Favorito LA. Prospective results of the minimally invasive laser enucleation of the prostate (MiLEP).\u0026nbsp;\u003cem\u003eProstate\u003c/em\u003e 84, 1501\u0026ndash;1505 (2024)\u003c/li\u003e\n \u003cli\u003eSchmidt J, Ralla B, Maxeiner A, Krediet J, Beutel H, Allah AH, et al. Minimally invasive holmium laser enucleation of the prostate (MiLEP) vs HoLEP: retrospective analysis of perioperative outcomes in a propensity score-matched cohort.\u0026nbsp;\u003cem\u003eProstate\u003c/em\u003e (2025)\u003c/li\u003e\n \u003cli\u003eRein P, Meisl C, Burkardt O, Abt D. Lessons learned from our preliminary experience with MiLEP: a retrospective analysis of efficacy and safety using slim and ultra-slim instruments.\u0026nbsp;\u003cem\u003eWorld J Urol\u003c/em\u003e 43, 424 (2025)\u003c/li\u003e\n \u003cli\u003eSaitta G, Becerra JEA, Del \u0026Aacute;lamo JF, Gonz\u0026aacute;lez LL, Elbers JR, Suardi N, et al. \u0026apos;En Bloc\u0026apos; HoLEP with early apical release in men with benign prostatic hyperplasia.\u0026nbsp;\u003cem\u003eWorld J Urol\u003c/em\u003e 37(11), 2451-2458. (2019)\u003c/li\u003e\n \u003cli\u003eHossack T, Woo H. Validation of a patient reported outcome questionnaire for assessing success of endoscopic prostatectomy. \u003cem\u003eProstate Int\u003c/em\u003e 2, 182\u0026ndash;187 (2014)\u003c/li\u003e\n \u003cli\u003eDe Nunzio C, Lombardo R, Autorino R, Cicione A, Cindolo L, Damiano R, et al. Contemporary monopolar and bipolar transurethral resection of the prostate: prospective assessment of complications using the Clavien system.\u0026nbsp;\u003cem\u003eInt Urol Nephrol\u003c/em\u003e 45, 951\u0026ndash;959 (2013)\u003c/li\u003e\n \u003cli\u003eMamoulakis C, Efthimiou I, Kazoulis S, Christoulakis I, Sophocleous G, Stolzenburg JU, et al. The modified Clavien classification system: a standardized platform for reporting complications in transurethral resection of the prostate.\u0026nbsp;\u003cem\u003eWorld J Urol\u003c/em\u003e 29, 205\u0026ndash;210 (2011)\u003c/li\u003e\n \u003cli\u003eNguyen DD, Li T, Ferreira R, Baker Berjaoui M, Nguyen AV, Chughtai B, et al. 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Risk factors for urethral stricture and/or bladder neck contracture after monopolar transurethral resection of the prostate for benign prostatic hyperplasia.\u0026nbsp;\u003cem\u003eUrologia\u003c/em\u003e 85, 150\u0026ndash;157 (2018)\u003c/li\u003e\n \u003cli\u003eThai KH, Smith JC, Stutz J, Sung J, Shaver C, El Tayeb MM. Urethral complications while using 26F vs 28F resectoscope sheaths in holmium laser enucleation of the prostate: a retrospective observational study.\u0026nbsp;\u003cem\u003eJ Endourol\u003c/em\u003e 35, 165\u0026ndash;170 (2021)\u003c/li\u003e\n \u003cli\u003eGrosso AA, Di Maida F, Nardoni S, Salvi M, Giudici S, Lambertini L, et al. Patterns and Predictors of Optimal Surgical and Functional Outcomes after Holmium Laser Enucleation of the Prostate (HoLEP): Introducing the Concept of \u0026quot;Trifecta\u0026quot;. \u003cem\u003eWorld J Mens Health\u003c/em\u003e ;41(3):603-611 (2023)\u003c/li\u003e\n \u003cli\u003eSecco S, Cindolo L. Do We Need Referral Centers for Benign Prostatic Hyperplasia that Offer Expertise in More Options? Yes, with a SMART (Specialized Medical Assessment for Right Treatment) Approach. \u003cem\u003eEur Urol Focus\u003c/em\u003e 26:S2405-4569(25)00067-7 (2025)\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-7401199/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7401199/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eMinimally invasive surgical therapies have transformed the management of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction. Holmium laser enucleation of the prostate (HoLEP) is considered the gold standard for men with bothersome LUTS. HoLEP is performed with 26Ch instruments, which can cause urethral trauma, strictures, transient incontinence. Recent miniaturised 22Ch tools (MiLEP) aim to reduce morbidity without compromising efficacy.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThis prospective multicenter study enrolled 65 men with BPH/BPO undergoing MiLEP. Preoperative assessment included IPSS, uroflowmetry, PSA, prostate volume and urinary continence. The MiLEP were performed en-bloc with early apical release. Follow-up assessed subjective and objective outcomes together with complications and patient satisfaction. Clinical success was defined as Trifecta. Logistic regression evaluated predictors of success.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eMean age was 68,3 years and mean operative time was 82 minutes. Mean resected tissue weight was 42,6g. No major intraoperative complications occurred; median catheterisation and hospital stay were 2 and 2 days, respectively. Overall complication rate was 18,4%, mostly Clavien\u0026ndash;Dindo grade I\u0026ndash;II. Late complications were urethral stricture in 4,6% and persistent stress incontinence in 1,5%. At 12months, mean IPSS, IPSS QoL, Qmax, PSA significantly improved (all p\u0026thinsp;\u0026lt;\u0026thinsp;0,001). Overall satisfaction was very high (97% \u0026ldquo;much or very much improved\u0026rdquo;). Trifecta was achieved in 61,5% of cases. Logistic regression identified lower pre operative Qmax as the only predictor of Trifecta achievement; prostate volume, age and resected tissue weight were not significant.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eMiLEP is a safe and effective alternative to conventional HoLEP. Significant improvements in symptom scores, flow rate and PSA were sustained at 12 months with low morbidity and high continence preservation. These findings suggest that MiLEP may expand the benefits of enucleation to patients who might otherwise face higher complication risks. Larger trials and longer follow up are needed to confirm our data.\u003c/p\u003e","manuscriptTitle":"Minimally invasive laser enucleation of the prostate (MiLEP) is feasible and safe: 12-month follow-up, real-life, prospective multicenter study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-08 08:39:16","doi":"10.21203/rs.3.rs-7401199/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c1eba256-5b98-4f11-97c8-278160f4516e","owner":[],"postedDate":"September 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":53806288,"name":"Health sciences/Medical research"},{"id":53806289,"name":"Health sciences/Diseases/Urogenital diseases"},{"id":53806290,"name":"Health sciences/Medical research/Outcomes research"}],"tags":[],"updatedAt":"2025-09-18T23:00:23+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-08 08:39:16","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7401199","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7401199","identity":"rs-7401199","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}