A comprehensive analysis of cost of an active surveillance cohort compared to radical prostatectomy as primary treatment for prostate cancer.

INTRODUCTION: Active surveillance (AS) seems to be a cost-effective strategy. However, most publications are based on simulation models of theoretical cohorts, and long-term implications are not usually considered. OBJECTIVE: To assess the real cost differences of two cohorts of men with low-risk prostate cancer (PCa) treated with AS or laparoscopic radical prostatectomy (LRP) in a public health system. MATERIALS AND METHODS: Patients diagnosed from 2005 to 2009 were included in an AS program (Group 1) or treated with LRP at diagnosis (Group 2), with a minimum follow-up of 5 years. Actual costs for each patient were calculated on an individual basis: Group 1: semiannual PSA measurements and repeat biopsies are scheduled every 1-3 years. Costs of outpatient clinic visits were calculated, as well as all tests required for monitoring or active treatment. Group 2: costs of the procedure, emergency visits, re-admissions and outpatient clinic visits were calculated, as well as costs of oncological salvage therapies or functional surgical procedures. RESULTS: Out of 151 men diagnosed with low-risk PC, 54 (35.8%) were included in an AS (Group 1) and 97 (64.2%) were submitted to LRP (Group 2). Mean follow-up for both groups was 6.5 years (SD 1.8) and 6.7 years (SD 1.4), respectively, p = 0.49. Group 1 had a total cost per patient of 2970.47€. Group 2 had a total cost per patient of 5694.06€. CONCLUSIONS: AS was associated with cost-saving over LRP. This cost reduction of AS in the management of low-risk PCa is based on the accounting of real costs of individual patients and confirms previously published estimation-based reports.

A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study.

BACKGROUND: The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. OBJECTIVE: To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. INTERVENTION: Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Qmax, prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. RESULTS AND LIMITATIONS: One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Qmax, and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1(st) yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. CONCLUSIONS: Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. PATIENT SUMMARY: The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement.

A European multicenter randomized noninferiority trial comparing 180 W GreenLight XPS laser vaporization and transurethral resection of the prostate for the treatment of benign prostatic obstruction: 12-month results of the GOLIATH study.

PURPOSE: We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments. MATERIALS AND METHODS: A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup. RESULTS: Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence. CONCLUSIONS: Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study.

BACKGROUND: The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. OBJECTIVE: The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were complication free. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. INTERVENTION: 180-W GL XPS system or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Measurements used were IPSS, Qmax, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. RESULTS AND LIMITATIONS: The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p<0.001). Early reintervention rate within 30 d was three times higher after TURP (p=0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. CONCLUSIONS: XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT01218672.

Weight of the resected specimen after transurethral resection as a new predictive variable for recurrence of non-muscle-invasive bladder tumour.

OBJECTIVE: To evaluate the role of the weight of the resected specimen after transurethral resection as a predictive factor for recurrence and progression of non-muscle-invasive bladder tumour (NMIBT). PATIENTS AND METHODS: The weight of the resected tumour was measured consecutively in 144 subjects who underwent transurethral resection of bladder tumours at our institution. The median (interquartile range [IQR]) follow-up was 58 (61.3) months. The probability of recurrence and progression at 1 and 5 years were calculated using the currently accepted variables. Thresholds for the specimen weight were determined according to percentiles and receiver-operating characteristic curves. RESULTS: The median (IQR) weight of the specimen was 6 (16) g. Multivariate analysis showed that the weight of the resected specimen was an independent predictive risk factor for recurrence at a threshold value of 6 g with a hazard ratio of 1.7 (95% confidence interval: 1.048-2.761) P = 0.03. Progression was not associated with the weight of the resected specimen. CONCLUSIONS: The weight of the resected specimen is a new variable for predicting the risk of recurrence of NMIBT. Tumours weighing >6 g, according to the present data, have a 1.7-fold higher likelihood of recurrence than those tumours that weigh less.

GreenLight HPS 120-W laser vaporization versus transurethral resection of the prostate for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: a randomized clinical trial with 2-year follow-up.

BACKGROUND: High-level evidence to support the use of photoselective vaporization of the prostate (PVP) is limited. OBJECTIVE: Assess the efficacy and safety of GreenLight HPS 120-W laser PVP compared with transurethral resection of the prostate (TURP). DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was performed with 50 patients having lower urinary tract symptoms due to benign prostatic hyperplasia in each treatment arm. INTERVENTION: Random allocation to PVP or TURP. MEASUREMENTS: International Prostate Symptom Score (IPSS), quality of life (QoL), and changes in maximum flow rate (Qmax) were the main end points. Patients were evaluated at a follow-up time of 2 yr. Five patients were lost to follow-up. A last observation carried forward analysis was done. RESULTS AND LIMITATIONS: Both laser PVP and TURP resulted in the same IPPS reduction at 2 yr (-15.7 and -14.9, respectively; p=0.48) and in the same gain in Qmax (+14.5 ml/s and +13.1 ml/s, respectively; p=0.65). QoL was equivalent for both treatment modalities. These results were independent of prostate size, American Society of Anesthesiologists risk category, and prior indwelling catheter. No statistically significant differences were detected between arms in terms of complication rates. In the laser PVP group, three patients were readmitted to the hospital and two developed a urethral stricture. In the TURP group, two patients were readmitted, six developed a urethral stricture, and two developed bladder neck sclerosis. In-hospital stay and time to catheter removal were significantly shorter with PVP. Limitations are the potential lack of power to detect differences in the complications between groups and the lack of blindness due to the nature of the intervention. CONCLUSIONS: GreenLight HPS 120-W laser PVP is as effective as TURP for symptom reduction and improvement of QoL. No differences were seen in the response of storage and voiding symptoms. Laser PVP and TURP have the same complication rate. Length of stay is shorter for laser PVP group.

Urethral stricture in women. Morphofunctional diagnosis and treatment.

OBJECTIVES: The objective of this article is to describe the diagnosis of bladder outlet obstruction in women and the treatment of urethral strictures as a cause of it. METHOD: A bibliographic review was performed in the Medline (PubMed) data base on articles published on the diagnosis of bladder outlet obstruction in women and the treatment of urethral stricture in the period between 1989-2009. RESULTS: The prevalence of obstruction in women varies between 2.7% and 23% in the literature. Videourodynamic studies are the gold standard for diagnosis. 78% of obstructions are functional, and only 6.8% are secondary to urethral stricture. Strictures commonly affect urethral meatus and distal third of the urethra, the most frequent cause being yatrogenic, secondary to incontinence surgery, urethral dilations and traumatic catheterization. The treatment of urethral stricture will depend on the location and length of the stricture, length of the healthy proximal urethra, bladder neck integrity and coexistence of incontinence. The repeat failure of non-invasive techniques and the presence of partial or total urethral defects will be subsidiary to urethral reconstruction techniques by means of flaps or grafts, although the technique of choice is still controversial. CONCLUSION: The diagnosis of bladder outlet obstruction in women is limited by the absence of clearly defined urodynamic parameters. Urethral stricture is an infrequent cause of obstruction, the treatment of which may constitute a therapeutic challenge. Early stricture relapse may constitute ground for considering early surgical reconstruction. Vaginal flaps are the cornerstone of urethral reconstructions. Extensive vulvar scarring may require the use of grafts.

Estenosis de uretra en la mujer. Diagnóstico morfo-funcional y tratamiento / Urethral stricture in women. Morphofunctional diagnosis and treatment

OBJETIVO: El objetivo del presente artículo es la descripción del diagnóstico de la obstrucción infravesical en la mujer y el tratamiento de la estenosis uretral como causa de la misma.MÉTODO: Se realizó una revisión bibliográfica en la base de datos de Medline (PubMed) de los artículos publicados sobre el diagnóstico de la obstrucción infravesical en la mujer y el tratamiento de la estenosis uretral en el periodo 1989-2009.RESULTADOS: La prevalencia de obstrucción en la mujer varía en la literatura entre el 2,7 y el 23%. El patrón de referencia para su diagnóstico es el estudio videourodinámico. El 78% de las obstrucciones son de carácter funcional y sólo un 6,8 % son secundarias a la estenosis uretral. La estenosis afecta comúnmente al meato uretral y el tercio distal de la uretra, y la causa más frecuente es la iatrogénica, secundaria a cirugía de la incontinencia, dilataciones uretrales y la cateterización traumática. El tratamiento de la estenosis de uretra dependerá de la localización y longitud de la estenosis, la longitud de la uretra sana proximal, la integridad del cuello vesical y la coexistencia de incontinencia. El fracaso repetido de técnicas no invasivas y la presencia de defectos parciales o totales de uretra serán subsidiarias de técnicas de reconstrucción uretral mediante colgajos o injertos, aunque la técnica de elección es motivo de controversia.CONCLUSIÓN: El diagnóstico de la obstrucción infravesical en la mujer está limitado por la ausencia de parámetros urodinámicos claramente definidos. La estenosis uretral es una causa infrecuente de obstrucción cuyo tratamiento puede constituir un desafio terapéutico. La recidiva precoz de la estenosis debería ser motivo para considerar la reconstrucción quirúrgica precoz. Los colgajos vaginales constituyen la base de las reconstrucciones uretrales. La cicatrización vulvar extensa pueden hacer necesaria la utilización de injertos(AU)

OBJECTIVES: The objective of this article is to describe the diagnosis of bladder outlet obstruction in women and the treatment of urethral stricture as a cause thereofMETHOD: A bibliographic review was performed in the Medline (PubMed) data base on articles published on the diagnosis of bladder outlet obstruction in women and the treatment of urethral stricture in the 1989-2009 period.RESULTS: The prevalence of obstruction in women varies between 2.7% and 23% in the literature. The gold standard for diagnosis is the videourodynamic study. 78% of obstructions are functional, and only 6.8% are secondary to urethral stricture. Stricture commonly affects the urethral meatus and the distal third of the urethra, the most frequent cause being yatrogenic, secondary to surgery for incontinence, urethral dilations and traumatic catheterisation. The treatment of urethral stricture will depend on the location and length of the stricture, the length of the healthy proximal urethra, bladder neck integrity and the coexistence of incontinence. The repeat failure of non-invasive techniques and the presence of partial or total urethra defects will be subsidiary to urethral reconstruction techniques by means of flaps or grafts, although the technique of choice is still controversial.CONCLUSION: The diagnosis of bladder outlet obstruction in women is limited by the absence of clearly defined urodynamic parameters. Urethral stricture is an infrequent cause of obstruction, the treatment of which may constitute a therapeutic challenge. Early stricture relapse may constitute grounds for considering early surgical reconstruction. Vaginal flaps are the cornerstone of urethral reconstructions. Extensive vulvar scarring may require the use of grafts(AU)