Hesperia Hospital

The evolving treatment landscape of muscle-invasive bladder cancer (MIBC) increasingly warrants novel trial design to evaluate perioperative strategies aimed at bladder preservation. To establish standardized outcome measures for evaluating organ preservation strategies in MIBC, the International Bladder Cancer Group (IBCG) and the Global Society of Rare Genitourinary Tumors (GSRGT) assembled an international, multidisciplinary consensus panel. The IBCG and GSRGT gathered global bladder cancer experts and patient advocates to establish a framework for risk-adapted bladder-sparing treatment approaches for MIBC. Working groups reviewed the literature and developed draft recommendations, which were discussed at a live meeting in December 2024 in Milan. This was followed by voting by the members using a modified Delphi process. Recommendations achieving ≥75% agreement during the meeting were further refined and presented. Clinical complete response (cCR) definition should encompass the absence of high-grade malignancy on pathology and malignant cells on urine cytology and no evidence of local or metastatic disease on cross-sectional imaging. Although cCR remains immature as a primary or coprimary end point in registrational trials, it could serve as a suitable end point in early-phase studies and risk-adapted investigations. Event-free survival (EFS) remains the preferred primary end point as it could reliably capture the durability of clinically meaningful benefit after omittance of surgical consolidation or chemoradiation. Given the composite nature of EFS, events should be prespecified, evaluated in an intention-to-treat approach, and meticulously collected. Continuous assessment of individual patient preferences should begin at the outset of perioperative therapy discussions, with informed decision making prioritized throughout. The consensus definition of cCR and the framework presented in this study can serve as a foundation for thorough testing of risk-adapted bladder-sparing treatment paradigms for MIBC.

Introduction. Mesotherapy is a widely used technique around the world. However, there is currently no internationally recognized, evidence-based standard for its various clinical applications. To address this gap, we have reviewed the current state of the art, critically evaluated its clinical benefits and limitations, and proposed a set of standards including procedural steps, recommended actions, and practical instructions in the form of protocols, guidelines, and expert recommendations. Methods. A team of researchers conducted a comprehensive literature review, selecting studies published between 1976 and 2023. Drawing on the available evidence and the needs expressed by patient associations, 23 clinical questions were developed and presented to a panel of experts. Through multiple rounds of evaluation, evidence-based recommendations were formulated and subsequently submitted for structured evaluation and voting by a broad, multidisciplinary panel of international experts, representing numerous national and international scientific societies. Results. The recommendations outlined in this guideline support the use of mesotherapy across diverse clinical and organizational settings, providing a standardized framework that ensures both efficacy and patient safety in osteoarticular pain, rehabilitation, and dermatological fields. Conclusions. The era of mesotherapy based on personal beliefs now gives way to evidence-based practice. The limitations underscore the need for continued high-quality research and scheduled guideline updates.

To the Editor, Bladder cancer is one of the most common cancers in humans, representing the 7th and 17th type of neoplasm in both genders. Its incidence and mortality are quite heterogeneous in different countries and are due to different risk factors, quality and prevalence of healthcare and the possibility of early diagnosis and treatment of the tumor and its potential recurrences [...].

Abstract Objectives Pharmacological treatment for erectile dysfunction (ED) is not always effective in patients with neurological disease; as such, penile prosthesis implant (PPI) can be a valid treatment option. We investigated outcomes of PPI in neurological patients using the Italian multi-institutional national registry of penile prostheses (INSIST-ED) Methods INSIST-ED registry, relating to patients implanted from 2014 to 2021, was analyzed. All data were prospectively recorded by 45 surgeons on a dedicated website (www.registro.andrologiaitaliana.it) and revised by a data-manager. We selected patients with neurological disease undergoing PPI for ED. Follow-up was scheduled at 3,6 and 12 months, then annually. We evaluated postoperative complications and functional outcomes through validated questionnaires (IIEF and EDITS). A non-validated questionnaire was administered to evaluate patient’satisfaction. Results 33 patients were included with a median age of 52 (IQR: 44.75-55.25). Peno-scrotal approach for PPI was performed in most cases (90.9%) while infra-pubic was used in 3 cases (9.1%). An inflatable and a malleabel device was implanted in 30 (90.9 %) and 3 cases (9.1 %), respectively. Median follow-up was 83 months (IQR: 67-99.5). Intraoperative complications occurred in one case (3%). Early postoperative complications (<90 days) were observed in 4 cases (12.1%): 3 peno-scrotal hematoma (Clavien-Dindo G1), 1 device infection requiring prosthesis explant (Clavien-Dindo G3a). At the last follow-up, 29 prostheses (87.9%) were still in place and well-functioning. Mechanical failure of inflatable PP occurred in 3 cases (9.1%). Median IIEF before surgery was 32 (IQR 30.25-36). At the last follow-up, IIEF was 61.5 (IQR 60.25-64.25), and median EDITS was 45.5 (IQR 39-46.75). Overall, 29 patients (87.9%) affirmed to be fully satisfied with the PPI. Conclusions Although PPI in the neurological population has been historically limited by the evidence of common complications and infections, our study showed that PPI represents a safe and effective procedure to treat ED in neurological patients. Conflicts of Interest The Authors have no conflict of interest.

Water vapor therapy (Rezum®; Boston Scientific, Marlborough, MA, USA) for bladder outflow obstruction (BOO) due to benign prostatic enlargement (BPE) is a minimally invasive and innovative surgical technique. The aim of this study was to evaluate its mid-term results in a large multicentric cohort of Italian patients. Patients with BPO and moderate to severe LUTS who underwent Rezum® (Boston Scientific) treatment from May 2019 to July 2021 were included in this study. Pre- and postoperative evaluation comprised full urological evaluation with urine culture, digital rectal examination, serum PSA, transrectal prostate ultrasound, uroflowmetry, post-void residual and IPSS, OAB-q SF, ICIQ-UI SF and IIEF-5, ejaculatory anterograde rate. Minimum follow-up was 12 months. Patients' subjective satisfaction was recorded with Patient Global Impression of Improvement (PGI-I) Scale together with any early or late reported complications, classified according to Clavien-Dindo Scale. Statistical analysis was conducted as appropriate. Overall, 352 patients were eligible for the analysis. Procedures were routinely done on an outpatient basis. Mean operative was 12 minutes. The catheter was left in place for a median of 7 days. After treatment, Q<inf>max</inf>, IPSS and IPSS-QoL, OAB-q SF, ICIQ-UI SF and IIEF-5 from baseline to last control follow-up (median 16, IQR 13-20 months) were improved (P<0.05). The postoperative anterograde ejaculation rate was recorded in 74.1% vs. preoperative 43.8% (P<0.001). Early (≤30 days) postoperative complications occurred in 176 patients (50%), all Clavien-Dindo Grade ≤2. One patient experienced clot retention and hematuria requiring hospitalization and blood transfusion. No late AEs were recorded. Surgical retreatment rate was 2.5% (9/352), all cases occurred within the first year. Median PGI-I was 2 (1-2). We confirmed the safety and efficacy of water vapor therapy for the treatment of symptomatic benign prostatic obstruction (BPO) on a large cohort of patients. Anterograde ejaculation was preserved in the majority of patients, with good subjective improvement. Further studies may rule out possible role of Rezum® (Boston Scientific) in new patients' setting.

Cardiac surgery in Jehovah's Witnesses (JW) patients who refuse blood transfusion is challenging requiring dedicated strategies. We aimed to analyze non-selected JW patients undergoing cardiac surgery and to compare with matched controls both perioperative outcomes and long-term survival. We retrospectively analyzed JW patients undergoing cardiac surgery from January 2016 to March 2021 and compared them with matched controls. The primary outcome was a composite of in-hospital perioperative adverse events and in-hospital mortality. The secondary outcome was all-cause mortality at long-term follow-up. A total of 113 JW patients and 113 controls were included. Baseline clinical characteristics, including laboratory parameters were comparable. Overall, there were no statistical differences between JW vs controls in terms of in-hospital mortality (2.7% vs 1.8%, p = 1.00) but mortality was remarkably high (40%) in JW patients with post-op hemoglobin < 8g/dl. Logistic regression analysis found that the JW group was not associated with a higher occurrence of the composite outcome (adjusted odds ratio 0.91, 95% confidence interval [CI] 0.54-1.57). After a median follow-up of 1397 [IQR 922.7-1723.5] days, JW patients were not associated with a significantly higher all-cause mortality (adjusted hazard ratio 0.77, 95% CI 0.24-2.42). Cardiac surgery can be safely performed in non-anemic JW patients despite the refusal of blood transfusions. Favorable clinical outcomes can be achieved by the use of specific perioperative strategies for bloodless surgery with no differences as compared to control patients except in JW patients with a very low level of post-operative hemoglobin not supported by immediate transfusions.