RESUMO
PURPOSE: The purpose of this American Urological Association (AUA) Guideline amendment is to provide a useful reference on the effective evidence-based management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH). MATERIALS AND METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies relevant to the management of BPH. The guideline was updated in 2023 to capture eligible literature published between September 2020 and October 2022. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. RESULTS: The BPH amendment resulted in changes to statements/supporting text on combination therapy, photoselective vaporization of the prostate (PVP), water vapor thermal therapy (WVTT), laser enucleation, and prostate artery embolization (PAE). A new statement on temporary implanted prostatic devices (TIPD) was added. In addition, statements on transurethral needle ablation (TUNA) and transurethral microwave thermotherapy (TUMT) were removed and information regarding these legacy technologies was added to the background section. References and the accompanying treatment algorithms were updated to align with the updated text. CONCLUSION: This guideline seeks to improve clinicians' ability to evaluate and treat patients with BPH/LUTS based on currently available evidence. Future studies will be essential to further support these statements to improve patient care.
Assuntos
Terapia a Laser , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Humanos , Masculino , Sintomas do Trato Urinário Inferior/terapia , Sintomas do Trato Urinário Inferior/complicações , Próstata/cirurgia , Hiperplasia Prostática/terapia , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata/métodos , Resultado do Tratamento , Guias de Prática Clínica como AssuntoRESUMO
PURPOSE: In recent years, water vapor thermal therapy (WVTT) has spread as minimally invasive technique in lower urinary tract symptoms due to benign prostatic hyperplasia treatment. Even if its safety and feasibility have been largely proved in young men, nobody has proved the same feasibility and safety in the elderly (men older than 75 years old). Our aim is to compare WVTT safety outcomes in men older than 75 with younger men. METHODS: We prospectively collected data on men who underwent water vapor thermal therapy from 2019. We compared data on operative time, number of injections, intra-operative and post-operative complications, reinterventions rate. RESULTS: We enrolled 426 patients; among these, 60 were older than 75 years old, 366 were younger. Our cohorts of patients had similar results in terms of intra-operative and post-operative complications. Operative time accounts about 11 min for both groups (p = 0.535), total number of injections was seven for young men and eight for elderly (p = 0.314). We found no intra-operative complications in elderly men group and only one in the younger group (p = 0.678), while five younger men underwent clot retention, and two elderly men experienced this complication (p = 0.239). Only one transfusion occurred in the elderly group. No differences between groups occurred in terms of length of stay, post-operative urinary retention and reintervention rate, while catheterization time was longer in the elderly men. CONCLUSION: WVTT is a safe procedure in elderly patients with comparable intra-operative and post-operative complication rate in comparison with younger patients.
Assuntos
Hipertermia Induzida , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Idoso , Humanos , Vapor , Idoso Fragilizado , Hiperplasia Prostática/complicações , Hipertermia Induzida/métodos , Itália , Sintomas do Trato Urinário Inferior/etiologia , Resultado do TratamentoRESUMO
PURPOSE: To investigate safety and feasibility of performing water vapor thermal therapy (WVTT; Rezum, Boston Scientific, Marlborough, MA, USA) without postoperative catheterization among men with benign prostatic hyperplasia. METHODS: This is a prospective, single arm, unblinded pilot study of 20 consecutive male patients ages 40-80 who underwent WVTT at a single academic institution. All patients underwent 1 injection per lobe at the point of maximal obstruction based on visualization. Primary outcome was evaluation of voiding parameters, symptom scores, and need for catheterization at 3 day, 1, 3, and 6 month follow up compared to baseline visit 30 days prior to surgery. RESULTS: Mean age was 65 years (range 55-75). Mean prostate volume and PVR were 43 cc (range 30-68) and 89 cc, with 30% (n = 6) having median lobes. Patients received 2-3 treatments based on presence of bilobar versus trilobar hyperplasia. One patient (55 cc prostate, no median lobe) required catheterization for acute urinary retention on postoperative day 2. No patients required antibiotics for urinary tract infection or inpatient readmission within 30 days. Qmax significantly increased from 6 mL/s to 8, 13, 12, and 14 at 3 days, 1, 3, and 6 months (p < 0.05). IPSS decreased from 17 preoperatively to 10, 6, 7, and 8 (p < 0.05). No significant differences were noted in PVR, IIEF, MSHQ-EjD, or SF-12. CONCLUSIONS: In well-selected men, catheter-free WVTT is feasible and improved voiding parameters and symptom scores. No changes in sexual function, infectious complications, or readmission were noted. Only 1 patient (5%) required postoperative catheterization within 30 days.
Assuntos
Estudos de Viabilidade , Hiperplasia Prostática , Vapor , Humanos , Masculino , Hiperplasia Prostática/terapia , Pessoa de Meia-Idade , Idoso , Estudos Prospectivos , Projetos Piloto , Resultado do Tratamento , Idoso de 80 Anos ou mais , Adulto , Hipertermia Induzida/métodosRESUMO
BACKGROUND: Benign prostatic hyperplasia (BPH) is a common chronic condition among men aged 50 or older, causing voiding and obstructive lower urinary tract symptoms. Water vapor thermal therapy (WVTT) using the Rezum® system is a new minimally invasive surgical technique that is increasingly reported as a treatment for BPH. METHODS: The protocol was submitted to the PROSPERO registry. We searched PubMed, Web of Science, Embase, Cochrane Library and ClinicalTrials.gov up to July 29, 2022. Quality assessment was carried out by a 20-item checklist form prepared by the Institute of Health Economics (IHE). Double arcsine transformation was performed to stabilize the variance of the original ratio. When I2 > 50%, the random effect model was used to calculate the pooled parameters. Otherwise, the fixed effect model was used. 95% confidence intervals (CIs) were calculated. A leave-one-out sensitivity analysis was performed to evaluate the impact of each study on the pooled outcomes, and finally, Egger's test was used to assess publication bias. RESULTS: A total of seven single-arm observational studies and one random controlled trial, including 1015 patients, were included. One year after WVTT, the International Prostate Symptom Score decreased by 11.37 (95% CI: -12.53, -10.21), the IPSS Quality of Life scale decreased by 2.59 (95% CI: -2.92, -2.26), the maximum urine flow rate increased by 5.26 ml/s (95% CI: 4.53, 5.99), and the postvoid residual decreased by 13.18 ml (95% CI: -24.32, -2.03). The most common complication was dysuria, with a pooled incidence of 21% (95% CI: 14%, 29%), and the second most common complication was hematuria, with a pooled incidence of 14% (95% CI: 10%, 18%). The pooled incidence of retreatment was 3% (95% CI: 2%, 5%). CONCLUSIONS: WVTT is an attractive alternative to medication or more invasive surgical procedures and can serve as first-line therapy for men with BPH.
Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Vapor , Próstata , Qualidade de Vida , Hiperplasia/complicações , Sintomas do Trato Urinário Inferior/etiologia , Resultado do TratamentoRESUMO
Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in men. When drug treatment is ineffective or conventional surgery is not suitable, novel minimally invasive therapies can be considered. These include prostatic urethral lift, prostatic artery embolisation, water vapor thermal therapy, Aquablation-image guided robotic waterjet ablation, temporary implantable nitinol device and prostatic stents. These novel therapies can be performed in outpatient setting under local anesthesia, with shorter operative and recovery times, and better protection of ejaculatory function and erectile function. General conditions of the patient and advantages and disadvantages of the each of these therapies should be fully considered to make individualized plans.
Assuntos
Embolização Terapêutica , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/complicações , Stents/efeitos adversos , Embolização Terapêutica/efeitos adversos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Resultado do Tratamento , Procedimentos Cirúrgicos Minimamente InvasivosRESUMO
PURPOSE: To perform a cost analysis of the current gold standard operation of Holmium Laser Enucleation of the prostate (HoLEP) compared to the new technique of water vapor thermal therapy with the Rezum™ system for the treatment of symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Between October 2017 and January 2020, consecutive patients with invalidating lower urinary tract symptoms due to BPH who underwent Rezum™ and HoLEP procedures from the Aix regional hospital were identified. The outcome of each technique was assessed in terms of cost from the institutional perspective. Detailed expense reports based were provided by the accounts department of the hospital. These were used to compare in-hospital costs for each procedure. RESULTS: A total of 53 and 94 consecutive patients underwent respectively water vapor thermal therapy and HoLEP. The median costs for the surgical procedure were 1344 (IQR 1331-1361) and 669 (IQR 584-824), respectively for Rezum™ and HoLEP (median difference 675; P<0.001). The median costs of the hospital stay were 869 (IQR 869-869) for Rezum™ and 1295 (IQR 1295-1330) for HoLEP (median difference 426; P<0.001). Finally, the median total costs per patient were lower for HoLEP (2005 [IQR 1902-2150]) than for Rezum™ (2228 [IQR 2209-2243]) procedure, and the median difference of 233 was significant (P<0.001). CONCLUSIONS: One of the anticipated benefits of Rezum™, reduced length of hospital stay with an associated reduction in cost, did not materialize within this study. The patient's clinical condition and expectations should also be taken into account when deciding between Rezum™ and standard therapies. LEVEL OF PROOF: 3.
Assuntos
Terapia a Laser , Lasers de Estado Sólido , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Custos e Análise de Custo , Humanos , Terapia a Laser/métodos , Lasers de Estado Sólido/uso terapêutico , Masculino , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Vapor , Ressecção Transuretral da Próstata/métodos , Resultado do TratamentoRESUMO
PURPOSE: To report our preliminary experience with water vapor thermal therapy with the Rezum™ System and Prostate Artery Embolization (PAE) for treatment of medically refractory, complete urinary retention to achieve successful cessation of catheter dependency in frail-patients. PATIENTS AND METHODS: A multi-institutional study was conducted including all patients who underwent Rezum™ procedure and PAE between October 2017 and June 2020. The included population focused on frail-patients unsuitable for conventional surgery with complete urinary retention. Rezum™ patients were identified and matched (1:1) with patients who underwent PAE. The matching criteria were age, Charlson score, prostate volume and duration of follow-up. The primary outcome was catheter-free survival, defined as spontaneous voiding and release from catheter dependence. RESULTS: Eleven patients from the Rezum™ group were matched to 11 embolized patients. PAE and Rezum™ patients were comparable in age (median: 77 vs. 75 years), Charlson score (median: 6 vs. 6) and prostate volume (74 vs. 60 cc). Procedures were significantly longer in the PAE group compared to the Rezum™ procedures (median: 148 vs. 8min, P<0.001). After a median follow-up of 12 months, spontaneous voiding was conserved in all cases (100%) after the Rezum™ procedure and in 5 cases (45.4%) after PAE (P=0.01). In catheter-free patients, the rate of benign prostatic hyperplasia medication use after procedure was 40% for PAE and 18.2% for Rezum™ patients (P=0.54). CONCLUSIONS: Our preliminary experience for treatment of complete urinary retention in frail-patients shows the feasibility of PAE and Rezum™ to restore spontaneous urination without being associated with the occurrence of major complications. Early data suggests that Rezum™ may provide superior results in terms of cessation of catheter dependence. Future studies are needed to definitively assess which treatment would be best suited for each patient. LEVEL OF EVIDENCE: 3.
Assuntos
Embolização Terapêutica , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Artérias , Cateteres de Demora , Humanos , Sintomas do Trato Urinário Inferior/terapia , Masculino , Próstata , Hiperplasia Prostática/complicações , Hiperplasia Prostática/terapia , Vapor , Resultado do Tratamento , Cateterismo Urinário , Cateteres UrináriosRESUMO
PURPOSE: Surgical therapies for symptomatic bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) are many, and vary from minimally invasive office based to high-cost operative approaches. This Guideline presents effective evidence-based surgical management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH). See accompanying algorithm for a detailed summary of procedures (figure[Figure: see text]). MATERIALS/METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible studies published between January 2007 and September 2020, which includes the initial publication (2018) and amendments (2019, 2020). The Team also reviewed articles identified by Guideline Panel Members. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table[Table: see text]). RESULTS: Twenty-four guideline statements pertinent to pre-operative and surgical management were developed. Appropriate levels of evidence and supporting text were created to direct urologic providers towards suitable and safe operative interventions for individual patient characteristics. A re-treatment section was created to direct attention to longevity and outcomes with individual approaches to help guide patient counselling and therapeutic decisions. CONCLUSION: Pre-operative and surgical management of BPH requires attention to individual patient characteristics and procedural risk. Clinicians should adhere to recommendations and familiarize themselves with criteria that yields the highest likelihood of surgical success when choosing a particular approach for a particular patient.
Assuntos
Disfunção Erétil/cirurgia , Sintomas do Trato Urinário Inferior/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Prostatectomia/normas , Hiperplasia Prostática/cirurgia , Disfunção Erétil/diagnóstico , Disfunção Erétil/etiologia , Humanos , Sintomas do Trato Urinário Inferior/diagnóstico , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/urina , Masculino , Tamanho do Órgão , Complicações Pós-Operatórias/etiologia , Próstata/patologia , Próstata/cirurgia , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/diagnóstico , Hiperplasia Prostática/patologia , Medição de Risco/normas , Índice de Gravidade de Doença , Sociedades Médicas/normas , Resultado do Tratamento , Estados Unidos , Urologia/métodos , Urologia/normasRESUMO
PURPOSE OF REVIEW: To explore the sexual outcomes following the novel minimally invasive surgical procedures for benign prostatic hyperplasia- (BPH-) related lower urinary tract symptoms (LUTS), with an emphasis on ejaculatory dysfunction (EjD). RECENT FINDINGS: A database search with a 10-year time restriction was carried out until February 20, 2020 using MEDLINE through the PubMed Platform evaluating minimally invasive treatment modalities for BPH and their effect on EjD. After the article selection, we retrieved data for men randomized in 19 different studies with results in 40 separate published articles investigating minimally invasive BPH surgery and reporting EjD rates. To date, water vapor thermal therapy or Rezum, prostatic urethral lift (PUL) or UroLift®, prostate artery embolization (PAE), and Aquablation showed acceptable rates (< 2%) of retrograde ejaculation by 1 year and had very low adverse events related to the procedure. Both PUL and Rezum demonstrated lower rates when compared with PAE and Aquablation. With comparable sexual side effect profiles postoperatively, clinicians may determine which therapeutic modality is optimal for patients based on efficacy and cost-benefit. Further randomized clinical trials are required to directly compare the effect of novel minimally invasive surgical procedures for BPH-related LUTS on ejaculation and sexual function.
Assuntos
Hiperplasia Prostática/terapia , Ejaculação/fisiologia , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/fisiopatologia , Sintomas do Trato Urinário Inferior/terapia , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/fisiopatologia , Hiperplasia Prostática/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Disfunções Sexuais Fisiológicas/etiologiaRESUMO
BACKGROUND: Men often experience deterioration of sexual function after the use of α-blockers and 5-α reductase inhibitors for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia. Thus, an alternative treatment with water vapor thermal therapy (Rezum System, Boston Scientific, Marlborough, MA, USA) which is an efficacious minimally invasive surgical treatment that preserves sexual function was examined. AIM: To compare sexual function over 3 years after continuous daily treatment with pharmaceutical agents in the Medical Therapy of Prostatic Symptoms (MTOPS) study vs a single thermal therapy procedure (Rezum study) in subjects with matched criteria for LUTS severity and prostate size. METHODS: We used sexual function data from sexually active cohorts in the MTOPS study (1,209) randomized to doxazosin, finasteride, combination drugs and placebo, and sexually active men who received thermal therapy (86). MTOPS study participants completed the Brief Male Sexual Function Inventory; men in the Rezum trial completed the International Index of Erectile Function and Male Sexual Health Questionnaire. MAIN OUTCOME MEASURE: Estimated mean changes from baseline for sexual function variables were compared using a linear mixed repeated measures model with fixed effects for treatment and follow-up visits. RESULTS: With continued daily drug use, men experienced significant worsening of sexual desire, erectile and ejaculatory function with finasteride and combination drug therapy, and reduced desire and erectile function with doxazosin. Thermal therapy was not associated with significant negative changes in sexual function throughout 3 years after treatment. CLINICAL IMPLICATIONS: Water vapor thermal therapy can result in greater LUTS improvements than either doxazosin or finasteride alone, whereas combination drug therapy may equal that of this Rezum procedure, but all drug therapies did have a significant negative impact on sexual function in contrast to the preservation of libido, erectile, and ejaculatory function after thermal therapy. STRENGTH & LIMITATIONS: The report includes high-quality data from 2 large randomized controlled trials in subjects with similar baseline inclusion criteria for LUTS severity and prostate size. It is the first longitudinal assessment of sexual function domains restricted to sexually active men treated with drugs or a single minimally invasive surgical treatment with the Rezum procedure. A limitation of the study is the use of 2 different, although validated sexual function inventories (Brief Male Sexual Function Inventory and International Index of Erectile Function). CONCLUSION: A single water vapor thermal therapy procedure for targeted prostate tissue ablation for LUTS/ benign prostatic hyperplasia had no deleterious effect on 4 sexual function domains compared with appreciable worsening of sexual function after long-term single or combination drug use. McVary KT, Rogers T, Mahon J, et al. Is Sexual Function Better Preserved After Water Vapor Thermal Therapy or Medical Therapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia? J Sex Med 2018;15:1728-1738.
Assuntos
Antagonistas de Receptores Adrenérgicos alfa 1/uso terapêutico , Hipertermia Induzida/métodos , Hiperplasia Prostática/terapia , Vapor , Inibidores de 5-alfa Redutase/uso terapêutico , Antagonistas Adrenérgicos alfa/uso terapêutico , Doxazossina/uso terapêutico , Quimioterapia Combinada , Humanos , Sintomas do Trato Urinário Inferior/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Ereção Peniana , Hiperplasia Prostática/complicações , Inquéritos e Questionários , Resultado do TratamentoRESUMO
PURPOSE: To report the efficacy and safety of water vapor thermal therapy to achieve catheter removal in frail patients with refractory acute urinary retention. METHODS: Data from consecutive frail patients with indwelling urinary catheter undergoing the Rezum™ therapy (Boston Scientific Corporation, Marlborough, MA) at a single center between October 2017 and June 2021 were prospectively collected. The included patients were deemed unfit or at high risk of complications for conventional benign prostatic hyperplasia (BPH) surgery. Prostate volumes up to 120 mL were considered eligible. The primary endpoint was successful cessation of catheter dependency, assessed postoperatively and up to 1 year of follow-up. RESULTS: A total of 24 men met our inclusion criteria. The median age, Charlson comorbidity index, and duration of preoperative catheterization were 77 years (IQR 67-86), 6 (IQR 3-7), and 113 days (IQR 87-159), respectively. Two cases (8.3%) of postoperative complications were recorded (Clavien II and Clavien IIIa). After a median postoperative catheterization time of 21 days (IQR 11-32), all patients regained spontaneous voiding. During follow-up, two patients died and a total of 22 patients completed the 1 year follow-up. All patients maintained spontaneous voiding without recurrence of urinary retention. No surgical retreatment was performed. In terms of pharmacological management, 22/24 patients (91.7%) had a BPH medication pre-Rezum™; this decreased to 8/22 patients (36.3%) post-Rezum™ (p < 0.001). CONCLUSIONS: In this single-institution, prospective, and observational study, water vapor thermal therapy was found to be effective and safe in restoring successful spontaneous voiding in a cohort of elderly and frail patients.
Assuntos
Hiperplasia Prostática , Retenção Urinária , Masculino , Idoso , Humanos , Idoso de 80 Anos ou mais , Retenção Urinária/terapia , Retenção Urinária/complicações , Cateteres de Demora/efeitos adversos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Vapor , Cateteres Urinários/efeitos adversos , Cateterismo Urinário , Estudos Prospectivos , Idoso Fragilizado , Resultado do TratamentoRESUMO
Introduction: Water vapor intraprostatic injection (Rezum procedure) for benign prostatic hyperplasia (BPH) is one of the most promising minimally invasive surgical treatments. Five-year outcomes from the multicenter randomized controlled trial (RCT) demonstrated significant and durable urinary and sexual function results in selected patients. We compared the sexual and urinary outcomes of this procedure in patients satisfying inclusion criteria of the RCT with unselected patients. Materials and Methods: We prospectively followed all patients with symptomatic BPH who underwent Rezum therapy at eight institutions and analyzed the functional results. Patients were divided into two groups: patients who matched the 5-year RCT inclusion criteria (Group A) and patients who did not (Group B). The pre- and postoperative data, complications, presence of antegrade ejaculation, and urinary and sexual outcomes were periodically recorded. Results: A total of 426 patients were eligible for the study (232 in Group A and 194 in Group B). Patients in Group B had a higher American Society of Anesthesiologists score, prostate volume, and postvoid residual measurement. No difference was found in terms of preoperative International Prostate Symptom Score, International Index of Erectile Function, maximum urinary flow, and prostate-specific antigen. Longer operative time and higher number of vapor injections were required in Group B, with no differences in hospital stay, injection density, and complication rates. All the urinary and sexual outcomes improved with no differences between the two groups. The reintervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in Group B. Conclusions: In our large multicenter series, water vapor intraprostatic injections showed a safe and effective profile regardless of the prostate size, presence of indwelling catheter, antiplatelet/anticoagulant medications, and patients' comorbidities.
Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/tratamento farmacológico , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/complicações , Vapor , Resultado do Tratamento , Sintomas do Trato Urinário Inferior/etiologia , Ressecção Transuretral da Próstata/métodosRESUMO
BACKGROUND: Several surgical treatments are available for managing lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). Water vapor thermal therapy (WVTT) is a new minimally invasive therapy. This study estimates the budget impact of introducing WVTT for LUTS/BPH into the Spanish health care system. METHODS: A model simulated the evolution of men over 45 years of age with moderate-severe LUTS/BPH after surgical treatment, over a 4-year time horizon, from the Spanish public health care service´s perspective. The technologies in scope included those most used in Spain: WVTT, transurethral resection (TURP), photoselective laser vapourization (PVP) and holmium laser enucleation (HoLEP). Transition probabilities, adverse events and costs were identified from the scientific literature and validated by a panel of experts. Sensitivity analyses were performed by varying the most uncertain parameters. RESULTS: Per intervention, WVTT resulted in savings of 3,317, 1,933 and 2,661 compared to TURP, PVP and HoLEP. Over a 4-year time horizon, when performed in 10% of the cohort of 109,603 Spanish males with LUTS/BPH, WVTT saved 28,770,125 against the scenario without WVTT availability. CONCLUSIONS: WVTT could reduce the cost of managing LUTS/BPH, increase the quality of health care and reduce the length of procedure and hospital stay.
Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Vapor , Sintomas do Trato Urinário Inferior/terapia , Sintomas do Trato Urinário Inferior/complicações , Orçamentos , Atenção à Saúde , Resultado do TratamentoRESUMO
Background: Current guidelines recommend Rezum water vapor thermal therapy for the treatment of benign prostatic hyperplasia (BPH) for prostate glands ranging in volume from 30 to 80 cm3. Few prospective studies have specifically evaluated the use of Rezum for larger prostates. Objective: To evaluate the safety and efficacy of water vapor thermal therapy in patients with a prostate gland >80 cm3 and ≤150 cm3. Design setting and participants: In this prospective, single-arm study at seven centers in the USA, subjects were males aged >50 yr with symptomatic BPH and prostate volume of >80 cm3 and ≤150 cm3. Intervention: Rezum was used to deliver sterile water vapor via a transurethral approach to ablate targeted areas of prostate tissue. Outcome measurements and statistical analysis: The primary efficacy outcome was response to therapy, defined on a per-patient basis as a ≥30% improvement in International Prostate Symptom Score (IPSS) from baseline to 6 mo. The primary safety outcome was a composite of serious device-related safety events. Secondary outcomes included catheterization for device-related retention. IPSS outcomes over time were analyzed via generalized estimating equations. Results and limitations: Among 47 eligible patients, prostate volume ranged from 80.8 to 148.1 cm3. All patients completed 6-mo follow-up, and 40/47completed 12-mo follow-up. At 6 mo, 83% were treatment responders according to the primary efficacy endpoint. The mean IPSS improvement at 6 mo was 11.9 ± 7.5 points, reflecting significant improvement. The primary safety outcome was met, with no occurrence of device-related composite safety events. The study is limited by the nonrandomized design and early termination, unrelated to safety or effectiveness. Conclusions: Our results are consistent with previous findings for prostate glands of up to 80 cm3, and indicate the safety and efficacy of Rezum for BPH in patients with a larger prostate. Patient summary: Rezum therapy, in which water vapor is used to treat targeted areas of the prostate, is currently recommended for patients with benign enlargement of the prostate and a prostate size of up to 80 cm3. We found that this treatment was also effective and safe in patients with a larger prostate of 80-150 cm3.
RESUMO
Objective: To understand which attributes men with benign prostatic hyperplasia (BPH) undergoing water vapor thermal therapy (WVTT) find important while considering treatment options for the condition. Methods: Men (n = 170) with lower urinary tract symptoms due to BPH who underwent WVTT between April 2019 and November 2020 in a Toronto urologic clinic were invited to participate in an online survey. The survey included eight attributes of BPH surgical procedures and five attributes of WVTT. Patients were asked how important each attribute was to them before they selected a BPH procedure and decided to undergo WVTT. Results: In total, 128 respondents (75%) completed the survey. A majority of the respondents were White (88%), married (83%), and aged 60-69 years old (45%). Approximately 97% of respondents rated the ability to avoid further BPH treatments as "very important" or "extremely important," followed by duration to return to normal activities (79%), and wait times to receive the procedure (57%). Only 47% of patients reported that postprocedural catheterization was important. For WVTT, 98% of the respondents rated avoiding more invasive surgical treatments and 88% rated a quick recovery as important attributes. Conclusions: Among men with moderate-to-severe BPH undergoing WVTT, the most important attributes for selecting a BPH surgical procedure were avoiding further BPH treatments, returning quickly to normal activities, and reducing treatment wait times. Most men chose WVTT to avoid more invasive procedures and have a quick recovery.
Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Hiperplasia Prostática/cirurgia , Vapor , Resultado do Tratamento , Procedimentos Cirúrgicos Minimamente Invasivos , Sintomas do Trato Urinário Inferior/cirurgiaRESUMO
BACKGROUND: Minimally invasive surgical therapies, such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL), are typically second-line options for patients in whom medical management (MM) failed but who are unwilling or unsuitable to undergo invasive transurethral resection of the prostate (TURP). However, the incremental cost-effectiveness of WVTT or PUL as first- or second-line therapy is unknown. We evaluated the incremental cost-effectiveness of alternative first- and second-line treatments for patients with moderate-to-severe benign prostatic hyperplasia (BPH) in Singapore to help policymakers make subsidy decisions based on value for money. METHODS: We considered six stepped-up treatment strategies, beginning with MM, WVTT, PUL or TURP. In each strategy, patients requiring retreatment advance to a more invasive treatment until TURP, which may be undergone twice. A Markov cohort model was used to simulate transitions between BPH severity states and retreatment, accruing costs and quality-adjusted life-years (QALYs) over a lifetime horizon. RESULTS: In moderate patients, strategies beginning with MM had similar cost and effectiveness, and first-line WVTT was incrementally cost-effective to first-line MM (33,307 SGD/QALY). First-line TURP was not incrementally cost-effective to first-line WVTT (159,361 SGD/QALY). For severe patients, WVTT was incrementally cost-effective to MM as a first-line treatment (30,133 SGD/QALY) and to TURP as a second-line treatment following MM (6877 SGD/QALY). TURP was incrementally cost-effective to WVTT as a first-line treatment (48,209 SGD/QALY) in severe patients only. All pathways involving PUL were dominated (higher costs and lower QALYs). CONCLUSION: Based on the common willingness-to-pay threshold of SGD 50,000/QALY, this study demonstrates the cost-effectiveness of WVTT over MM as first-line treatment for patients with moderate or severe BPH, suggesting it represents good value for money and should be considered for subsidy. PUL is not cost-effective as a first- nor second-line treatment. For patients with severe BPH, TURP as first-line is also cost-effective.
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate, common among older men. Its symptoms include difficulties with starting and completing urination, incontinence, frequent and urgent need to urinate. Minimally invasive procedures, such as water vapor thermal therapy (WVTT) and prostatic urethral lift (PUL), are typically offered as second-line options to patients for whom medication has failed but who are unwilling or unsuitable to undergo invasive surgery (transurethral resection of the prostate, TURP). However, whether offering these procedures as first-line options represents good value for money (i.e. cost-effectiveness) is an open question. To address this question and inform subsidy decisions in Singapore, we investigated six stepped-up treatment strategies which differ in first- and second-line treatments. For each strategy, we simulated healthcare costs and quality of life for a cohort of moderate and severe BPH patients over their lifetime, considering the possibility of treatment-related adverse effects and multiple rounds of retreatment. The incremental cost of a unit improvement in quality of life for a strategy relative to the next most expensive one was compared against a willingness-to-pay threshold to determine cost-effectiveness. We found that WVTT was cost-effective relative to medication as a first-line treatment for patients with moderate or severe BPH, suggesting it represents good value for money and should be considered for subsidy. PUL was not cost-effective as first- nor second-line treatment. TURP is cost-effective as first-line for severe BPH patients only.
Assuntos
Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Análise Custo-Benefício , Ressecção Transuretral da Próstata/efeitos adversos , Singapura , Procedimentos Cirúrgicos Minimamente Invasivos , Resultado do TratamentoRESUMO
AIM: The aim of this work is to evaluate the initial experience with water vapor thermal therapy (WVTT) for benign prostatic hyperplasia (BPH) in Spanish university hospitals, as well as to describe the differences in technique and follow-up between centers. MATERIALS AND METHODS: This retrospective observational multicenter study collected baseline characteristics, surgical, postoperative and follow-up data at 1, 3, 6, 12 and 24 months, including validated questionnaires, flowmetric variations, complications, and the need for pharmacological or surgical treatment following the procedure. Possible triggers for postoperative acute urinary retention (AUR) were also analyzed. RESULTS: A total of 105 patients were included. No differences were observed between the groups with and without AUR with respect to catheterization time (5 and 4.3 days respectively, P=.178), or prostate volume (47.9g and 41.4g respectively, P=.147). The mean improvement at 3, 6, 12 and 24 months in terms of peak flow was 5.3, 5.2, 4.2 and 3.8ml/s, respectively. As for ejaculation, an improvement was observed after 3 months of follow-up and was maintained over time. CONCLUSIONS: Minimally invasive treatment for BPH with WVTT shows good functional outcomes at 24 months follow-up, without significant impairment of sexual function and a low incidence of complications. There are minor inter-hospital variations, mainly in the immediate postoperative period.
Assuntos
Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Seguimentos , Vapor , Resultado do Tratamento , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , HospitaisRESUMO
Water vapor thermal therapy is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses steam to ablate prostatic tissue to relieve lower urinary tract symptoms associated with BPH. It is an option for 30 to 80 g prostates in well-selected patients, and may avoid sexual side effects seen in other more invasive BPH treatments. It is a simple procedure with a short learning curve that can be performed in-office under local and oral anesthesia. Water vapor therapy should be offered to ideal candidates along with information regarding its risks, benefits, and outcomes.
Assuntos
Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Próstata/cirurgia , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Vapor , Resultado do TratamentoRESUMO
Purpose: Water vapor thermal therapy (WVTT, i.e., Rezum®) and prostatic urethral lift (PUL, i.e., Urolift®) are minimally invasive surgical therapy (MIST) options for benign prostatic hyperplasia (BPH). Few studies have directly compared the two procedures. We examined the clinical characteristics and postoperative outcomes of patients undergoing WVTT and PUL at our high-volume urban academic center. Methods: We reviewed our institutional MIST database to identify patients with prostate sizes ≥30 and ≤80 cc who underwent WVTT or PUL for treatment of BPH between January 2017 and September 2021. Pre- and postoperative outcomes, including retreatment rates, American Urological Association symptom score (AUA-SS), maximum flow (Qmax), postvoid residual (PVR), medication usage, trial of void success rates, catheterization requirements, and postoperative complications within 90 days were extracted and compared between procedures. Results: Three hundred seven patients received WVTT and 110 patients received PUL with average follow-up times of 11.3 and 12.8 months, respectively. WVTT patients showed significant improvements in AUA-SS, Qmax, and PVR, whereas PUL patients showed improvements in only AUA-SS and Qmax. Both WVTT and PUL patients with longitudinal follow-up demonstrated improvements in AUA-SS, Qmax, and PVR. Postoperatively, alpha-blocker utilization was significantly decreased following both WVTT and PUL (WVTT: 73.9%-46.6%, PUL: 76.4%-38.2%, both p < 0.001). Compared to patients receiving PUL, WVTT patients more frequently reported postoperative dysuria (22.8% vs 8.3%, p = 0.001) and nonclot-related retention (18.9% vs 7.3%, p = 0.005); PUL patients more frequently experienced postoperative clot retention (7.3% vs 2.6%, p = 0.027). There were no differences in rates of postoperative bladder spasm, trial of void success, urinary tract infections, or emergency department visits. Postoperative erectile dysfunction and retrograde ejaculation were rare and occurred at similar rates. Conclusion: In the real-world setting, WVTT and PUL have similar medium-term efficacy in improving symptoms and decreasing medication utilization for patients with BPH. Differences in postoperative complication profiles should inform patient counseling.
Assuntos
Hiperplasia Prostática , Humanos , Masculino , Hiperplasia Prostática/cirurgia , Próstata/cirurgia , VaporRESUMO
CONTEXT: In recent years, new technologies have been developed to treat benign prostatic enlargement (BPE). Three of these devices may be utilized in office and are promising additions. OBJECTIVE: To systematically review all clinical trials investigating prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), and temporary implantable nitinol device (TIND), with emphasis on clinical efficacy and complications. EVIDENCE ACQUISITION: We performed a systematic review of PubMed/Medline database in November 2020 according to Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. EVIDENCE SYNTHESIS: Of 168 articles identified, 18 met the inclusion criteria. Evidence consisted of few randomized controlled trials, and multiple single-arm prospective and retrospective studies. Among the three modalities, PUL demonstrates rare occurrence of serious complications but higher retreatment rates at short- and long-term follow-up. WVTT offers lower retreatment rates with a similar safety profile. TIND studies report varying rates of retreatment and complications. All technologies offer low rates of erectile and ejaculatory dysfunction, although the risk appears to be highest for WVTT (<10.8%). CONCLUSIONS: Among the emerging technologies introduced to treat BPE, the in-office PUL, WVTT, and TIND systems are valuable additions to the current surgical options. These systems offer unique advantages that should be considered in the shared decision-making process. PATIENT SUMMARY: In this report, we identified all clinical trials reporting on the efficacy and safety of the in-office prostatic urethral lift (PUL), water vapor thermal therapy (WVTT), and temporary implantable nitinol device (TIND) systems for the treatment of benign prostatic enlargement. We found that PUL and WVTT demonstrate acceptable outcomes in terms of functional improvement, retreatment, and complications. More data with longer follow-up are required to further evaluate TIND, but early results are promising.