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1.
Prostate Cancer Prostatic Dis ; 26(3): 538-542, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-35851618

RESUMO

OBJECTIVE: To compare the initial perioperative outcomes of single-port transvesical simple prostatectomy (SP RASP) patients to those of open simple prostatectomy (OSP). PATIENTS AND METHODS: Perioperative data from 42 consecutive patients with BPH who underwent SP RASP were prospectively reviewed. Similarly, data from forty-three consecutive patients who underwent the standard OSP, were retrospectively collected. Through direct suprapubic bladder access, prostatic enucleation was performed using the prostatic capsule as a landmark. Then a complete vesicourethral mucosal advancement flap was accomplished. OSP was performed according to the standard approach. Demographics, Intra- and perioperative data were analyzed and assessed with a descriptive analysis. RESULTS AND LIMITATIONS: Baseline characteristics were comparable between the two groups, except for the preoperative median post-void residual volume, which was higher in the OSP group (p = 0.004). The SP RASP group had less intraoperative estimated blood loss (p < 0.001), no need for continuous bladder irrigation (p < 0.001), and less in-hospital opioid use (p < 0.001). Patients in the SP RASP group were discharged on postoperative day zero, compared to a median of 2 days for OSP (p < 0.001). The median Foley catheter duration was 7 days for SP RASP, compared to a median of 10 days for OSP (p < 0.001). SP RASP group had fewer postoperative complications, however, this did not reach statistical significance. CONCLUSION: SP RASP is an alternative approach in treating surgical BPH. It may offer patients less morbidity in comparison to OSP.


Assuntos
Hiperplasia Prostática , Neoplasias da Próstata , Procedimentos Cirúrgicos Robóticos , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/complicações , Estudos Retrospectivos , Neoplasias da Próstata/cirurgia , Resultado do Tratamento , Tempo de Internação , Prostatectomia/métodos , Procedimentos Cirúrgicos Robóticos/métodos , Perda Sanguínea Cirúrgica
2.
Brachytherapy ; 21(1): 85-93, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34656435

RESUMO

PURPOSE/OBJECTIVE(S): To determine if patients with unfavorable intermediate-risk (UIR), high-risk (HR), or very high-risk (VHR) prostate cancer (PCa) treated with 125I interstitial brachytherapy benefit from androgen deprivation therapy (ADT). MATERIALS/METHODS: We reviewed our institutional database of patients with UIR, HR, or VHR PCa, per 2018 NCCN risk classification, treated with definitive 125I interstitial brachytherapy with or without ADT from 1998-2017. Outcomes including biochemical failure (bF), distant metastases (DM), and overall survival (OS) were analyzed with the Kaplan-Meier method and Cox proportional hazards regression. PCa-specific mortality (PCSM) was analyzed with Fine-Gray competing-risk regression. RESULTS: Of 1033 patients, 262 (25%) received ADT and 771 (75%) did not. Median ADT duration was 6 months. By risk group, 764 (74%) patients were UIR, 219 (21%) HR, and 50 (5%) VHR. ADT was more frequently given to HR (50%) and VHR (56%) patients compared to UIR (16%; p<0.001), to older patients (p<0.001), corresponding with increasing PSA (p<0.001) and Grade Group (p<0.001). Median follow-up was 4.9 years (0.3-17.6 years). On multivariable analysis accounting for risk group, age, and year of treatment, ADT was not associated with bF, DM, PCSM, or OS (p≥0.05 each). CONCLUSION: Among patients with UIR, HR, and VHR PCa, the addition of ADT to 125I interstitial brachytherapy was not associated with improved outcomes, and no subgroup demonstrated benefit. Our findings do not support the use of ADT in combination with 125I interstitial brachytherapy. Prospective studies are required to elucidate the role of ADT for patients with UIR, HR, and VHR PCa treated with prostate brachytherapy.


Assuntos
Braquiterapia , Neoplasias da Próstata , Antagonistas de Androgênios/uso terapêutico , Androgênios , Braquiterapia/métodos , Humanos , Radioisótopos do Iodo , Masculino , Antígeno Prostático Específico , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Próstata/radioterapia , Estudos Retrospectivos
4.
J Urol ; 206(3): 715-724, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33872051

RESUMO

PURPOSE: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezum™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSIONS: Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.


Assuntos
Hipertermia Induzida/métodos , Sintomas do Trato Urinário Inferior/terapia , Hiperplasia Prostática/terapia , Idoso , Estudos Cross-Over , Disfunção Erétil/epidemiologia , Disfunção Erétil/etiologia , Seguimentos , Humanos , Hipertermia Induzida/efeitos adversos , Hipertermia Induzida/estatística & dados numéricos , Sintomas do Trato Urinário Inferior/diagnóstico , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Hiperplasia Prostática/complicações , Qualidade de Vida , Retratamento/estatística & dados numéricos , Índice de Gravidade de Doença , Disfunções Sexuais Fisiológicas/epidemiologia , Disfunções Sexuais Fisiológicas/etiologia , Vapor , Estados Unidos
5.
Brachytherapy ; 19(1): 43-50, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31813740

RESUMO

PURPOSE: To validate the 2019 NCCN subgroups of favorable- and unfavorable-intermediate risk (IR) prostate cancer among patients treated with brachytherapy, who are underrepresented in the studies used to develop the 2019 NCCN classification. METHODS: We included all 2,705 men treated with I-125 LDR brachytherapy monotherapy at a single institution, and who could be classified into the 2019 NCCN risk groups. Biochemical failure and distant metastasis rates were calculated using cumulative incidence analysis. RESULTS: Of 1,510 IR patients, 756 (50%) were favorable-IR, and 754 (50%) were unfavorable-IR. Median follow up was 48 months (range, 3-214). As compared to favorable-IR, the unfavorable-IR group was associated with significantly higher rates of biochemical failure (HR, 2.87; 95% CI, 2.00-4.10; p < 0.001) and distant metastasis (HR, 3.14; 95% CI, 1.78-5.50, p < 0.001). For favorable-IR vs. unfavorable-IR groups, 5-year estimates of biochemical failure were 4.3% (95% CI, 2.6-6.1%) vs. 17.0% (95% CI, 13.6-20.5%; p < 0.001), and for distant metastasis were 1.6% (95% CI, 0.5-2.6%) vs. 5.4% (95% CI, 3.3-7.4%; p < 0.001), respectively. Patients with one unfavorable-intermediate risk factor (unfavorable-IRF; HR, 2.27; 95% CI, 1.54-3.36; p < 0.001) and 2-3 unfavorable-IRFs (HR, 4.42; 95% CI, 2.89-6.76; p < 0.001) had higher biochemical failure rates; similar findings were observed for distant metastasis (1 unfavorable-IRF: HR, 2.46; 95% CI, 1.34-4.53, p = 0.004; 2-3 unfavorable-IRFs: HR, 4.76; 95% CI, 2.49-9.10, p < 0.001). CONCLUSIONS: These findings validate the prognostic utility of the 2019 NCCN favorable-IR and unfavorable-IR prostate cancer subgroups among men treated with brachytherapy. Androgen deprivation was not beneficial in any subgroup. Alternative treatment intensification strategies for unfavorable-IR patients are warranted.


Assuntos
Braquiterapia , Recidiva Local de Neoplasia/sangue , Neoplasias da Próstata/classificação , Neoplasias da Próstata/radioterapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Seguimentos , Humanos , Radioisótopos do Iodo , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Prognóstico , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Fatores de Risco
6.
Urology ; 137: 115-120, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31785277

RESUMO

OBJECTIVE: To determine the relationship between urologic oncology fellowship training (UOFT) and diagnostic yield of prostate biopsy. METHODS: Retrospective review was conducted of patients who underwent prostate biopsy across the Cleveland Clinic between 2000 and 2018. Biopsies done by urologists with and without UOFT were detailed via descriptive statistics and appropriate (chi-square, Student t, Wilcoxon rank-sum) tests. Multivariate logistic regression was used to examine the association between UOFT and positive prostate biopsy, adjusting for relevant covariates. RESULTS: A total of 11,241 biopsies by 129 urologists had complete information available for review. Sixteen urologists (12.4%) had UOFT; 113 either completed a different fellowship or no fellowship. Those with UOFT were more likely to use MRI-guided biopsy (7.80% vs 3.05%, P <.0001), more likely to get a positive biopsy (41.25% vs 32.72%, P <.0001), and more likely to obtain an adequate number (by ≥12) of cores (90.25% vs 74.53%, P <.0001). UOFT remained a significant predictor of positivity when adjusting for patient age and race, PSA, 5-alpha-reductase-inhibitor use, year of biopsy, years in practice, and type of biopsy (MRI or transrectal ultrasound guided). UOFT also predicted higher-risk biopsy (Gleason sum ≥7), adjusting for the same variables, though this association lost significance when adjusting for adequacy of biopsy. The learning curve to achieve a higher percentage of positive biopsies was steeper for nonurologic oncology fellowship trained than for UOFT urologists. CONCLUSION: UOFT is associated with higher diagnostic yield on prostate biopsy, higher uptake of MRI-guided biopsy, and less steep learning curve. This may be due to patient selection, technique, or, as we demonstrate here, adherence to guidelines.


Assuntos
Educação , Bolsas de Estudo , Biópsia Guiada por Imagem/métodos , Próstata/patologia , Neoplasias da Próstata/patologia , Urologia/educação , Idoso , Competência Clínica , Erros de Diagnóstico/prevenção & controle , Educação/métodos , Educação/normas , Bolsas de Estudo/métodos , Bolsas de Estudo/estatística & dados numéricos , Humanos , Curva de Aprendizado , Imagem por Ressonância Magnética Intervencionista/métodos , Masculino , Pessoa de Meia-Idade , Melhoria de Qualidade , Ultrassonografia de Intervenção/métodos , Estados Unidos
7.
8.
Urology ; 134: 192-198, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31542460

RESUMO

OBJECTIVE: To test the hypothesis that transurethral prostate procedures (TUPPs) eliminating tissue result in greater medication discontinuation and lower de novo initiation rates than procedures inducing tissue necrosis. METHODS: Retrospective review of all men undergoing first time TUPPs at a large tertiary center from 2001 to 2016 was completed. Procedure type and urologic medication use before, 3-12 months after, and greater than 12 months after TUPP were analyzed with simple open prostatectomy as a comparator. Tissue-eliminating TUPPs included transurethral resection of the prostate and laser prostatectomy. Tissue-necrosing procedures included microwave therapy (transurethral microwave therapy) and radiofrequency ablation (transurethral needle ablation), which were grouped in analyses. Medication types were 5-alpha reductase inhibitors (5ARI), alpha blockers, anticholinergics, and beta-3 agonists (B3A). RESULTS: A total 5150 TUPPs were analyzed. Preoperative medication use significantly varied across TUPPs for 5ARI (P <.01), alpha-blockers (P .01), and anticholinergics (P .047), but not B3A (P .476). Transurethral resection of the prostate and laser prostatectomy were associated with significantly higher medication discontinuation rates and lower resumption and initiation rates compared to tissue-necrosing procedures. Relative to TUPPs, simple prostatectomy had significantly higher medication discontinuation, as well as the lowest resumption and initiation rates. CONCLUSION: Tissue-eliminating benign prostatic hyperplasia procedures were associated with better medication discontinuation, resumption, and de novo initiation rates compared to tissue-necrosing benign prostatic hyperplasia procedures.


Assuntos
Uso de Medicamentos/estatística & dados numéricos , Micro-Ondas/uso terapêutico , Prostatectomia , Hiperplasia Prostática/terapia , Terapia por Radiofrequência , Ressecção Transuretral da Próstata , Inibidores de 5-alfa Redutase/uso terapêutico , Antagonistas Adrenérgicos alfa/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Idoso , Antagonistas Colinérgicos/uso terapêutico , Desprescrições , Humanos , Masculino , Prostatectomia/métodos , Estudos Retrospectivos
9.
Curr Urol Rep ; 20(8): 45, 2019 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-31218458

RESUMO

PURPOSE OF REVIEW: To provide an economic context within which to consider treatment options for benign prostatic hyperplasia (BPH). To this end, this review provides a comparison of the costs of combination medical therapy, operative treatment, and office-based therapies for BPH from a payer perspective. RECENT FINDINGS: Analysis of Medicare charges from the authors' institution, as well as local retail costs of medication, demonstrated a wide range in costs of commonly used BPH treatments. In this study, interventions for BPH reached cost equivalence with combination medical therapy within 6 months to 8 years. A myriad of options for managing men with symptomatic BPH exist. It is prudent not only to consider surgeon preference and patient-specific factors when selecting a treatment but also to understand the economic impact different BPH therapies confer.


Assuntos
Hiperplasia Prostática/economia , Hiperplasia Prostática/terapia , Terapia Combinada/economia , Custos e Análise de Custo , Humanos , Masculino , Medicare/economia , Estados Unidos , Procedimentos Cirúrgicos Urológicos Masculinos/economia , Procedimentos Cirúrgicos Urológicos Masculinos/métodos , Agentes Urológicos/economia , Agentes Urológicos/uso terapêutico
10.
Curr Urol Rep ; 19(9): 72, 2018 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-30022307

RESUMO

PURPOSE OF REVIEW: To review the costs associated with benign prostatic hyperplasia (BPH) management. Specifically, to compare the costs of medical therapy, office-based procedures, and surgical management from a payer perspective. RECENT FINDINGS: The American Urological Association released updated guidelines in 2018 for the surgical management of BPH. Over recent years, analyses investigating the cost-effectiveness of the modalities included in these guidelines have been completed. These show relatively newer, minimally-invasive office-based therapies can provide cost-effective alternatives to medical therapy. Likewise, surgical therapies provide a cost-effective means of BPH management, if performed well with low complication rates. However, comparisons of these studies are limited by the biases they contain. Minimally-invasive office-based therapies and well performed surgical therapies for BPH can achieve cost equivalence to combination medical therapy within a few years. Factors such as age, gland size, patient compliance, and surgeon skill should be considered when personalizing treatment recommendations for each patient.


Assuntos
Hiperplasia Prostática/economia , Hiperplasia Prostática/terapia , Inibidores de 5-alfa Redutase/uso terapêutico , Antagonistas Adrenérgicos alfa/uso terapêutico , Procedimentos Cirúrgicos Ambulatórios/economia , Análise Custo-Benefício , Quimioterapia Combinada/economia , Humanos , Estilo de Vida , Masculino , Medicare/economia , Estados Unidos , Procedimentos Cirúrgicos Urológicos Masculinos/economia
11.
Clinicoecon Outcomes Res ; 10: 29-43, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29343977

RESUMO

OBJECTIVE: To conduct a cost-effectiveness analysis from payers' perspectives of six treatments for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and to examine positioning of these modalities in the marketplace for the best use of health care funds and quality-of-life benefits for patients. METHODS: The economic analysis was conducted with a Markov model to compare combination prescription drug therapy (ComboRx), minimally invasive therapies (MITs) including convective radiofrequency (RF) water vapor thermal therapy (Rezum®), conductive RF thermal therapy (Prostiva®), and prostatic urethral lift (UroLift®), and invasive surgical procedures including photovaporization of the prostate (Greenlight® PVP) and transurethral resection of the prostate (TURP). Effects assessed with International Prostate Symptom Score, adverse events, and re-treatment rates were estimated from medical literature; treatments effects were modeled using a common baseline score. Starting with each therapy, patients' transitions to more intensive therapies when symptoms returned were simulated in 6-month cycles over 2 years. Incremental cost-effectiveness ratios (ICERs) were calculated for pairs of treatments; uncertainty in ICERs was estimated with probabilistic sensitivity analyses. RESULTS: ComboRx was least effective and provided one-third of the symptom relief achieved with MITs. UroLift was similar in effectiveness to Prostiva and Rezum but costs more than twice as much. The cheaper MITs were ~$900 more expensive than the cost of ComboRx generic drugs over 2 years. TURP and PVP provided slightly greater relief of LUTS than MITs at approximately twice the cost over 2 years; typically, they are reserved for treatment of more severe LUTS. CONCLUSION: The analysis evaluated the costs and symptom relief of six treatment options in the continuum of care from a common baseline of LUTS severity. Identification of treatments for LUTS/BPH that demonstrate cost-effectiveness and provide appreciable symptom relief is paramount as reimbursement for patient care moves from volume-based services to value-based services.

12.
J Urol ; 198(5): 1129, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28757122
13.
Int J Radiat Oncol Biol Phys ; 97(5): 962-975, 2017 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-28333019

RESUMO

PURPOSE: We compare the efficacy and toxicity among the 3 major modalities available used to treat high-risk prostate cancer (HRCaP). METHODS AND MATERIALS: From 1996 to 2012, 2557 HRCaP patients were treated: 734 received external beam radiation therapy (EBRT) with or without androgen deprivation therapy (ADT), 515 received low-dose-rate prostate brachytherapy (LDR) with or without ADT, and 1308 received radical prostatectomy (RP) with or without EBRT. Biochemical relapse-free survival (bRFS), clinical relapse-free survival (cRFS), and prostate cancer-specific mortality (PCSM) were assessed. Toxicity was assessed using the Common Terminology Criteria for Adverse Events, version 4.03. The log-rank test compared bRFS and cRFS among the modalities, and Cox regression identified factors associated with bRFS and cRFS. Gray's test compared differences in late toxicity and PSCM among the modalities. Competing risk regression identified factors associated with PCSM. RESULTS: The median follow-up time and age were 63.5 months and 65 years, respectively. The bRFS at 5 and 10 years, respectively, was 74% and 53% for EBRT, 74% and 52% for LDR, and 65% and 47% for RP (P=.0001). The cRFS at 5 and 10 years, respectively, was 85% and 73% for EBRT, 90% and 76% for LDR, and 89% and 75% for RP (P=.121). The PCSM at 5 and 10 years, respectively, was 5.3% and 11.2% for EBRT, 3.2% and 3.6% for LDR, and 2.8% and 6.8% for RP (P=.0004). The 10-year cumulative incidence of ≥grade 3 genitourinary toxicity was 8.1% for EBRT, 7.2% for LDR, and 16.4% for RP (P<.0001). The 10-year cumulative incidence of ≥grade 3 gastrointestinal toxicity was 4.6% for EBRT, 1.1% for LDR, and 1.0% for RP (P<.0001). CONCLUSION: HRCaP treated with EBRT, LDR, or RP yields efficacy showing better bRFS for LDR and EBRT relative to RP, equivalence for cRFS, and a PCSM advantage of LDR and RP over EBRT. The toxicity is lowest for LDR.


Assuntos
Braquiterapia/mortalidade , Quimiorradioterapia/mortalidade , Gastroenteropatias/mortalidade , Prostatectomia/mortalidade , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/terapia , Radioterapia Conformacional/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Androgênios/administração & dosagem , Braquiterapia/estatística & dados numéricos , Quimiorradioterapia/estatística & dados numéricos , Intervalo Livre de Doença , Gastroenteropatias/prevenção & controle , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Ohio/epidemiologia , Prostatectomia/estatística & dados numéricos , Lesões por Radiação/mortalidade , Lesões por Radiação/prevenção & controle , Radioterapia Adjuvante/mortalidade , Radioterapia Adjuvante/estatística & dados numéricos , Radioterapia Conformacional/estatística & dados numéricos , Estudos Retrospectivos , Terapia de Salvação/mortalidade , Terapia de Salvação/estatística & dados numéricos , Taxa de Sobrevida , Resultado do Tratamento
14.
J Urol ; 197(6): 1507-1516, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-27993667

RESUMO

PURPOSE: We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezum® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. RESULTS: Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported. CONCLUSIONS: Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.


Assuntos
Sintomas do Trato Urinário Inferior/terapia , Terapia por Radiofrequência , Convecção , Estudos Cross-Over , Método Duplo-Cego , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Hiperplasia Prostática/complicações , Terapia por Radiofrequência/métodos , Fatores de Tempo , Resultado do Tratamento
16.
J Sex Med ; 13(6): 924-33, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27129767

RESUMO

INTRODUCTION: Most surgical treatments for male lower urinary tract symptoms and benign prostatic hyperplasia affect erectile and ejaculatory functions negatively, leading to patient dissatisfaction. AIM: To determine whether water vapor thermal therapy, when conducted in a randomized controlled trial, would significantly improve lower urinary tract symptoms secondary to benign prostatic hyperplasia and urinary flow rate while preserving erectile and ejaculatory functions. METHODS: Men at least 50 years old with International Prostate Symptom Scores of at least 13, a peak flow rate of at least 5 to no higher than 15 mL/s, and prostate volume of 30 to 80 cm(3) were randomized 2:1 between Rezum System thermal therapy and control. Thermal water vapor (103°C) was injected into lateral and median lobes as required for treatment of benign prostatic hyperplasia. The control procedure entailed rigid cystoscopy with simulated active treatment sounds. MAIN OUTCOME MEASURES: Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for International Prostate Symptom Score, peak flow rate, and sexual function using the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. The minimal clinically important difference in erectile function perceived by subjects as beneficial was determined for each erectile function severity category. Subjects not sexually active were censored from sexual function analysis. RESULTS: No treatment- or device-related de novo erectile dysfunction occurred after thermal therapy. International Index of Erectile Function and Male Sexual Health Questionnaire for Ejaculatory Function scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (P = .0011). Also, 32% of subjects achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. International Prostate Symptom Score and peak flow rate were significantly superior to controls at 3 months and throughout 1 year (P < .0001). CONCLUSION: Convective water vapor thermal therapy provides sustainable improvements for 12 months to lower urinary tract symptoms and urinary flow while preserving erectile and ejaculatory functions.


Assuntos
Sintomas do Trato Urinário Inferior/terapia , Ereção Peniana , Hiperplasia Prostática/complicações , Idoso , Idoso de 80 Anos ou mais , Cistoscopia , Método Duplo-Cego , Ejaculação , Disfunção Erétil/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Vapor , Inquéritos e Questionários , Resultado do Tratamento
17.
J Urol ; 195(5): 1529-1538, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26614889

RESUMO

PURPOSE: This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezum® System and control. Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary end point compared International Prostate Symptom Score reduction at 3 months. Treatment subjects were followed for 12 months. RESULTS: There were 197 men randomized (active 136, control 61). Thermal therapy and control International Prostate Symptom Score was reduced by 11.2 ± 7.6 and 4.3 ± 6.9 respectively (p <0.0001). Treatment subject baseline International Prostate Symptom Score of 22 decreased at 2 weeks (18.6, p=0.0006) and by 50% or greater at 3, 6 and 12 months, p <0.0001. The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p <0.0001). No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly. CONCLUSIONS: Convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia symptoms and preserves erectile and ejaculatory function. Treatment can be delivered in an office or hospital setting using oral pain medication and is applicable to all prostate zones including the median lobe.


Assuntos
Hipertermia Induzida/métodos , Sintomas do Trato Urinário Inferior/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata/métodos , Urodinâmica/fisiologia , Cistoscopia , Método Duplo-Cego , Seguimentos , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/fisiopatologia , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/complicações , Hiperplasia Prostática/diagnóstico , Vapor , Fatores de Tempo , Resultado do Tratamento
18.
Urol Pract ; 3(3): 175-179, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-37592563

RESUMO

INTRODUCTION: As health care reform is ongoing, reimbursement will continually be increasingly scrutinized and decreased despite growing numbers of patients with comorbid medical conditions. This study determined the impact of inpatient comorbidity documentation on hospital reimbursement in a female pelvic medicine and reconstructive surgery group. METHODS: Departmental financial records from 2011 to 2012 were reviewed. All admissions by 4 female pelvic medicine and reconstructive surgeons at a tertiary referral center were collected. All DRG (Diagnosis Related Group) codes of pathological conditions specific to males, stones and nonsubspecialty issues were excluded from analysis. Using CMS (Centers for Medicare and Medicaid Services) reimbursement rates the effects of documenting and coding comorbidities or complications were determined. Geographic multipliers were excluded. The study objective was to determine the impact of inpatient documentation on hospital reimbursement from a urological subspecialty group. RESULTS: Each of 4 surgeons admitted an average of 29 inpatients per year of whom 29% had a comorbidity or complication documented. Mean reimbursement was $3,486 greater for cases with versus without a coded comorbidity or complication. This resulted in an additional $31,374 of reimbursement annually per surgeon or $125,496 for the group. CONCLUSIONS: Documenting comorbidities and complications in urology patients appropriately results in a substantial increase in reimbursement. Care should be taken by urologists to accurately note comorbid medical conditions. This is especially crucial as health care reform continues and growing numbers of patients present with chronic disease while reimbursement is further scrutinized and decreased.

19.
Int J Radiat Oncol Biol Phys ; 92(4): 884-93, 2015 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-25962627

RESUMO

PURPOSE/OBJECTIVES: To report long-term efficacy and toxicity for a single-institution cohort of patients treated with low-dose-rate prostate brachytherapy permanent implant (PI) monotherapy. METHODS AND MATERIALS: From 1996 to 2007, 1989 patients with low-risk (61.3%), intermediate-risk (29.8%), high-intermediate-risk (4.5%), and high-risk prostate cancer (4.4%) were treated with PI and followed up prospectively in a registry. All patients were treated with (125)I monotherapy to 144 Gy. Late toxicity was coded retrospectively according to a modified Common Terminology Criteria for Adverse Events 4.0 scale. The rates of biochemical relapse-free survival (bRFS), distant metastasis-free survival (DMFS), overall survival (OS), and prostate cancer-specific mortality (PCSM) were calculated. We identified factors associated with late grade ≥3 genitourinary (GU) and gastrointestinal (GI) toxicity, bRFS, DMFS, OS, PCSM, and incontinence. RESULTS: The median age of the patients was 67 years, and the median overall and prostate-specific antigen follow-up times were 6.8 years and 5.8 years, respectively. The overall 5-year rates for bRFS, DMFS, OS, and PCSM were 91.9%, 97.8%, 93.7%, and 0.71%, respectively. The 10-year rates were 81.5%, 91.5%, 76.1%, and 2.5%, respectively. The overall rates of late grade ≥3 GU and GI toxicity were 7.6% and 0.8%, respectively. On multivariable analysis, age and prostate length were significantly associated with increased risk of late grade ≥3 GU toxicity. The risk of incontinence was highly correlated with both pre-PI and post-PI transurethral resection of the prostate. CONCLUSIONS: Prostate brachytherapy as monotherapy is an effective treatment for low-risk and low-intermediate-risk prostate cancer and appears promising as a treatment for high-intermediate-risk and high-risk prostate cancer. Significant long-term toxicities are rare when brachytherapy is performed as monotherapy.


Assuntos
Braquiterapia/métodos , Neoplasias da Próstata/radioterapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Braquiterapia/efeitos adversos , Estudos de Coortes , Intervalo Livre de Doença , Seguimentos , Hemorragia Gastrointestinal/etiologia , Trato Gastrointestinal/efeitos da radiação , Humanos , Fístula Intestinal/etiologia , Radioisótopos do Iodo/uso terapêutico , Masculino , Pessoa de Meia-Idade , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/patologia , Lesões por Radiação/patologia , Dosagem Radioterapêutica , Risco , Fatores de Tempo , Ressecção Transuretral da Próstata/efeitos adversos , Incontinência Urinária/etiologia , Sistema Urogenital/efeitos da radiação
20.
Pract Radiat Oncol ; 5(5): e437-e442, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25899222

RESUMO

PURPOSE: To ascertain the safety and efficacy of permanent prostate brachytherapy (PPB) in early prostate cancer patients who have undergone previous total proctocolectomy and J-pouch anastomosis for inflammatory bowel disease. METHODS AND MATERIALS: We identified 10 patients with a previous history of prostate cancer and J-pouch anastomosis from our institutional review board-approved database. Seven patients had PPB and 3 had prostatectomy. Only patients treated with PPB were included. Patient records were reviewed to collect data on treatment-related toxicity and oncological outcomes. RESULTS: All 7 patients who underwent PPB had low- to intermediate-risk prostate cancer. The mean prostatic volume was 24.40 mL and the average number of iodine-125 seeds implanted was 84. Postimplant dosimetric calculations showed a mean prostate volume receiving 100% of the prescribed dose (V100) of 88.76%, V150 of 45.23%, V200 of 16.79%, radiation dose delivered to 90% of the prostate of 147.89 Gy, volume of ileal pouch receiving 100% of the prescribed dose of 0.164 mL, and volume of ileal pouch receiving 50% of the prescribed dose of 1.38 mL. After a mean follow-up of 19 months, none of the patients had evidence of biochemical failure or clinical failure. There were no long-term genitourinary side effects detected. Two patients had Common Terminology Criteria for Adverse Events version 4.0 grade II gastrointestinal side effects, of which symptoms resolved to baseline in 1 patient, whereas the other patient progressed to chronic active enteritis (pouchitis). CONCLUSION: Low- to intermediate-risk prostate cancer patients with J-pouch anastomosis after total colectomy for inflammatory bowel disease are candidates for definitive treatment with PPB. Caution should be exercised while deploying the most posterior row of seeds to minimize enteral pouch radiation doses.


Assuntos
Braquiterapia/métodos , Colectomia/métodos , Colite Ulcerativa/terapia , Iodo/uso terapêutico , Neoplasias da Próstata/complicações , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/radioterapia
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