{"title":"前列腺肥大患者的水蒸气热疗（Rezūm 系统）：一项前瞻性比较研究的结果。","authors":"Raffaele Balsamo, Simone Tammaro, Massimiliano Trivellato, Felice Crocetto, Biagio Barone, Ferdinando Fusco, Davide Arcaniolo, Celeste Manfredi, Luca Cindolo, Raffaele Ranavolo, Francesco Uricchio","doi":"10.23736/S2724-6051.24.05883-X","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Rezūm is a novel minimally invasive surgical technique (MIST) useful for BPH patients with medium-sized prostate (30-80 cm<sup>3</sup>) refractory to medical treatment. The aim of this study was to evaluate the efficacy and safety of Rezūm as a treatment option in large-sized prostates (>80 cm<sup>3</sup>).</p><p><strong>Methods: </strong>We performed a prospective, comparative, single-center study from June 2022 to June 2023, including consecutive patients undergoing surgery with the Rezūm System. Enrolled men were classified into two subgroups based on prostate size: medium prostate (MP) (30-80 cm<sup>3</sup>) and large prostate (LP) (≥80 cm<sup>3</sup>). Inclusion criteria included an International Prostate Symptom Score (IPSS) Total score of ≥ 8 points. International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual (PVR), and International Index of Erectile Function 5-item version (IIEF-5) were collected at baseline and at three, six, and 12 months post-procedure. Ejaculation presence was assessed at 3 months. Post-operative complications were described using the Clavien-Dindo (CD) classification. The primary outcome was the IPSS-Total score, with intraoperative and postoperative CD grade ≥III complications as secondary outcomes.</p><p><strong>Results: </strong>One hundred and twenty-one patients (PV 78.2±32.1 mL) were included in the study, 51 large prostate (LP) and 70 medium prostate (MP). The IPSS-Total score and Q<inf>max</inf> showed a statistically significant (P<0.0001) improvement at 3, 6, and 12 months respectively. PVR decreased at 3, 6, and 12 months; however, only at 3 months this variation was statistically significant (P<0.0001). At 3-month follow-up, anejaculation was detected in (3; 5.8% and 1; 1.4%) patients in LP and MP group respectively (P=0.86). IIEF-5 significantly improved 3 months after surgery in the LP subgroup (P<0.0001).</p><p><strong>Conclusions: </strong>Rezūm water vapor therapy appears to be effective for treating BPH in larger prostates. Additionally, it demonstrates a low risk of impairing sexual function, indicating a favorable safety profile.</p>","PeriodicalId":53228,"journal":{"name":"Minerva Urology and Nephrology","volume":null,"pages":null},"PeriodicalIF":4.9000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Water vapor thermal therapy (Rezūm System) in patients with large prostates: results from a prospective comparative study.\",\"authors\":\"Raffaele Balsamo, Simone Tammaro, Massimiliano Trivellato, Felice Crocetto, Biagio Barone, Ferdinando Fusco, Davide Arcaniolo, Celeste Manfredi, Luca Cindolo, Raffaele Ranavolo, Francesco Uricchio\",\"doi\":\"10.23736/S2724-6051.24.05883-X\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Rezūm is a novel minimally invasive surgical technique (MIST) useful for BPH patients with medium-sized prostate (30-80 cm<sup>3</sup>) refractory to medical treatment. The aim of this study was to evaluate the efficacy and safety of Rezūm as a treatment option in large-sized prostates (>80 cm<sup>3</sup>).</p><p><strong>Methods: </strong>We performed a prospective, comparative, single-center study from June 2022 to June 2023, including consecutive patients undergoing surgery with the Rezūm System. Enrolled men were classified into two subgroups based on prostate size: medium prostate (MP) (30-80 cm<sup>3</sup>) and large prostate (LP) (≥80 cm<sup>3</sup>). Inclusion criteria included an International Prostate Symptom Score (IPSS) Total score of ≥ 8 points. International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual (PVR), and International Index of Erectile Function 5-item version (IIEF-5) were collected at baseline and at three, six, and 12 months post-procedure. Ejaculation presence was assessed at 3 months. Post-operative complications were described using the Clavien-Dindo (CD) classification. The primary outcome was the IPSS-Total score, with intraoperative and postoperative CD grade ≥III complications as secondary outcomes.</p><p><strong>Results: </strong>One hundred and twenty-one patients (PV 78.2±32.1 mL) were included in the study, 51 large prostate (LP) and 70 medium prostate (MP). The IPSS-Total score and Q<inf>max</inf> showed a statistically significant (P<0.0001) improvement at 3, 6, and 12 months respectively. PVR decreased at 3, 6, and 12 months; however, only at 3 months this variation was statistically significant (P<0.0001). At 3-month follow-up, anejaculation was detected in (3; 5.8% and 1; 1.4%) patients in LP and MP group respectively (P=0.86). IIEF-5 significantly improved 3 months after surgery in the LP subgroup (P<0.0001).</p><p><strong>Conclusions: </strong>Rezūm water vapor therapy appears to be effective for treating BPH in larger prostates. Additionally, it demonstrates a low risk of impairing sexual function, indicating a favorable safety profile.</p>\",\"PeriodicalId\":53228,\"journal\":{\"name\":\"Minerva Urology and Nephrology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2024-11-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Minerva Urology and Nephrology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.23736/S2724-6051.24.05883-X\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Minerva Urology and Nephrology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.23736/S2724-6051.24.05883-X","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Water vapor thermal therapy (Rezūm System) in patients with large prostates: results from a prospective comparative study.
Background: Rezūm is a novel minimally invasive surgical technique (MIST) useful for BPH patients with medium-sized prostate (30-80 cm3) refractory to medical treatment. The aim of this study was to evaluate the efficacy and safety of Rezūm as a treatment option in large-sized prostates (>80 cm3).
Methods: We performed a prospective, comparative, single-center study from June 2022 to June 2023, including consecutive patients undergoing surgery with the Rezūm System. Enrolled men were classified into two subgroups based on prostate size: medium prostate (MP) (30-80 cm3) and large prostate (LP) (≥80 cm3). Inclusion criteria included an International Prostate Symptom Score (IPSS) Total score of ≥ 8 points. International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual (PVR), and International Index of Erectile Function 5-item version (IIEF-5) were collected at baseline and at three, six, and 12 months post-procedure. Ejaculation presence was assessed at 3 months. Post-operative complications were described using the Clavien-Dindo (CD) classification. The primary outcome was the IPSS-Total score, with intraoperative and postoperative CD grade ≥III complications as secondary outcomes.
Results: One hundred and twenty-one patients (PV 78.2±32.1 mL) were included in the study, 51 large prostate (LP) and 70 medium prostate (MP). The IPSS-Total score and Qmax showed a statistically significant (P<0.0001) improvement at 3, 6, and 12 months respectively. PVR decreased at 3, 6, and 12 months; however, only at 3 months this variation was statistically significant (P<0.0001). At 3-month follow-up, anejaculation was detected in (3; 5.8% and 1; 1.4%) patients in LP and MP group respectively (P=0.86). IIEF-5 significantly improved 3 months after surgery in the LP subgroup (P<0.0001).
Conclusions: Rezūm water vapor therapy appears to be effective for treating BPH in larger prostates. Additionally, it demonstrates a low risk of impairing sexual function, indicating a favorable safety profile.
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