Long-term medical-care costs related to prostate cancer: estimates from linked SEER-Medicare data.

Limited data are available concerning long-term prostate cancer (PCa)-related medical costs for use in assessing PCa prevention strategies. The aim of this study was to examine treatment, long-term survival, and long-term PCa-related costs by cancer stage. Costs in phases of care based on the natural history of PCa were also examined. Our data illustrate that initial care is characteristic of a rapid rate of cost accrual. This rate then decreases during continuing care. For terminal care, only stage IV resumes a rate of cost accrual similar to initial care. With average PCa-related costs of $18,168 observed over an average follow-up of 4 years, prevention strategies may result in a reduction in medical costs.

First-year costs of treating prostate cancer: estimates from SEER-Medicare data.

Pharmacologic therapies are currently being evaluated for the prevention of prostate cancer (PCa). As additional clinical data become available regarding their benefits and risks, an examination of their economic impact will also be important. The purpose of this study was to estimate mean per patient PCa-related costs during the first year following diagnosis and to examine the extent to which initial therapies are used, by initial cancer stage. Our data show that health-care costs were significant and varied by stage. With average first-year PCa-related costs of US$13,091, prevention strategies have the potential to reduce health-care costs.

Questionnaire-based assessment of bladder dysfunction in patients with mild to moderate Parkinson's disease.

OBJECTIVES: To assess the lower urinary tract symptoms (LUTS) in men and women with mild to moderate Parkinson's disease (PD) using validated symptom questionnaires. METHODS: Eighty men and 39 women with mild to moderate PD (Hoehn and Yahr score less than 3) were mailed LUTS questionnaires to complete and return. Men received the American Urological Association Symptom Index and women received the Urogenital Distress Inventory-6. Patients not responding by mail were called and asked to complete the survey over the telephone. Control populations of both symptomatic and asymptomatic men and women (without PD) were identified for comparison. RESULTS: The overall response rate was 78%. Men with early-stage PD had higher American Urological Association Symptom Index scores than age-matched controls (total score of 12.0 versus 7.7, P <0.05) and scores similar to those reported for men with symptomatic benign prostatic hyperplasia (12.5). Specific items noted to be higher among the men with PD included questions regarding frequency and urgency. Women with PD had higher scores on the Urogenital Distress Inventory-6 than non-age-matched controls (total score of 4.8 versus 2.1, P <0.05), but lower scores than an age-matched group of neurologically intact women presenting for urologic evaluation of LUTS (6.9, P <0.05). CONCLUSIONS: On the basis of the responses to the validated symptom indexes, the development of LUTS appears to occur at an earlier stage of PD than was once appreciated. Prompt evaluation and treatment of patients with lower urinary tract complaints in the setting of PD may identify bladder dysfunction at an earlier, more treatable stage.

Economic analysis of finasteride: a model-based approach using data from the Proscar Long-Term Efficacy and Safety Study.

Benign prostatic hyperplasia (BPH) is one of the most common medical conditions in older men in the United States. BPH is often associated with a reduction in quality of life and may progress to acute urinary retention (AUR), the inability to pass any urine. Recently, a 4-year placebo-controlled clinical trial known as the Proscar Long-Term Efficacy and Safety Study (PLESS) demonstrated that finasteride use reduces the risk of developing AUR by 57% and the need for BPH-related surgery by 55%. The economic implications of these findings were investigated using a model-based decision-analytic approach to compare finasteride with both watchful waiting and alpha-blocker therapy. The modeling used the longest-term published controlled data concerning alpha-blockers, which were for the alpha-blocker terazosin. The base case considered a 64-year-old man (the mean age of a PLESS patient) with prostatic enlargement on digital rectal examination and moderate-to-severe symptoms of BPH. The model suggested savings in surgical and AUR costs with finasteride versus watchful waiting, with an estimated 25% of total finasteride costs recouped in savings on surgical events avoided in the first year. Over 2 years, the expected cost per patient starting finasteride therapy was $2304, whereas the expected cost per patient starting terazosin was $2334. Analyses also explored the variation in economic results by baseline levels of prostate-specific antigen (PSA), a proxy for prostate volume. For patients with PSA levels > or =1.4 ng/mL, expected 2-year costs with finasteride and terazosin were $2342 and $2479, respectively. For patients with PSA levels > or =3.3 ng/mL, expected 2-year costs with finasteride were $373 less than with terazosin ($2347 vs $2720). Results were robust over a range of model assumptions and cost estimates. The analyses illustrate that all medical interventions, including watchful waiting, have associated costs. Finasteride shows cost offsets compared with watchful waiting and cost savings compared with terazosin over 2 years. Finasteride appears to be more economical in men with higher PSA levels.

Optimal method of urgent decompression of the collecting system for obstruction and infection due to ureteral calculi.

PURPOSE: We compare the efficacy of percutaneous nephrostomy with retrograde ureteral catheterization for renal drainage in cases of obstruction and infection associated with ureteral calculi. MATERIALS AND METHODS: We randomized 42 consecutive patients presenting with obstructing ureteral calculi and clinical signs of infection (temperature greater than 38 C and/or white blood count greater than 17,000/mm.3) to drainage with percutaneous nephrostomy or retrograde ureteral catheterization. Preoperative patient and stone characteristics, procedural parameters, clinical outcomes and costs were assessed for each group. RESULTS: Urine cultures obtained at drainage were positive in 62.9% of percutaneous nephrostomy and 19.1% of retrograde ureteral catheterization patients. There was no significant difference in the time to treatment between the 2 groups. Procedural and fluoroscopy times were significantly shorter in the retrograde ureteral catheterization (32.7 and 5.1 minutes, respectively) compared with the percutaneous nephrostomy (49.2 and 7.7 minutes, respectively) group. One treatment failure occurred in the percutaneous nephrostomy group, which was successfully salvaged with retrograde ureteral catheterization. Time to normal temperature was 2.3 days in the percutaneous nephrostomy and 2.6 in the retrograde ureteral catheterization group, and time to normal white blood count was 2 days in the percutaneous nephrostomy and 1.7 days in the retrograde ureteral catheterization group (p not significant). Length of stay was 4.5 days in the percutaneous nephrostomy group compared with 3.2 days in the retrograde ureteral catheterization group (p not significant). Cost analysis revealed that retrograde ureteral catheterization was twice as costly as percutaneous nephrostomy. CONCLUSIONS: Retrograde ureteral catheterization and percutaneous nephrostomy effectively relieve obstruction and infection due to ureteral calculi. Neither modality demonstrated superiority in promoting a more rapid recovery after drainage. Percutaneous nephrostomy is less costly than retrograde ureteral catheterization. The decision of which mode of drainage to use may be based on logistical factors, surgeon preference and stone characteristics.

Serial prostate-specific antigen measurements in men with clinically benign prostatic hyperplasia during a 12-month placebo-controlled study with terazosin. HYCAT Investigator Group. Hytrin Community Assessment Trial.

OBJECTIVES: To prospectively analyze whether the treatment of men with clinically benign prostatic hyperplasia (BPH) with alpha blocking agents affects the serum prostate-specific antigen (PSA) levels, and to determine the magnitude of such effect. METHODS: Serial PSA measurements were performed using the Abbott IMx assay over 1 year in 134 men over the age of 55 years participating in the Hytrin Community Assessment Trial (HYCAT). HYCAT is a 1-year, randomized, placebo-controlled, double-blinded study of the alpha1-adrenergic antagonist terazosin. All men had lower urinary tract symptoms and a clinical diagnosis of BPH with an American Urological Association (AUA) symptom index of 13 points or more, an AUA bother score of 8 points or more, and a peak urinary flow rate of less than 15 mL/s. PSA was measured at baseline and at 8, 26, 39, and 52 (end of study) weeks. RESULTS: Baseline serum PSA levels weakly correlated with patients' age at study entry, and modestly with residual urine (positive correlation) and peak flow rate (negative correlation), although none of the levels were statistically significant. Changes of serum PSA during the course of the study did not correlate with either one of the symptom severity or bother assessment tools, residual urine, or peak flow rate. Mean PSA increased from a baseline of 2.5+/-0.22 ng/mL (mean+/-SE) by 0.5+/-0.11 ng/mL in the placebo-, and from 2.7+/-0.23 ng/mL by 0.3+/-0.11 ng/mL in the terazosin-treated patients (P = 0.36 by ANOVA). There were no differences in the changes in serum PSA when patients were stratified by decade of life according to the age-specific PSA reference ranges, or by the final dose of terazosin (2, 5, or 10 mg daily). CONCLUSIONS: The treatment of men with lower urinary tract symptoms and clinical BPH with the alpha1-adrenergic antagonist terazosin does not affect serum PSA concentration, and thus does not confound longitudinal monitoring of serum PSA levels in patients at risk for prostate carcinoma.

Antimicrobial prophylaxis prior to shock wave lithotripsy in patients with sterile urine before treatment: a meta-analysis and cost-effectiveness analysis.

OBJECTIVES: To determine the efficacy and cost-effectiveness of routine antimicrobial prophylaxis prior to shock wave lithotripsy (SWL) in patients with a sterile pretreatment urine culture. METHODS: A structured MedLine search revealed eight prospective, randomized, controlled trials (RCTs) of active treatment versus placebo or no treatment (n = 885) and six clinical series (non-RCTs; n = 597) addressing the use of antimicrobial prophylaxis for SWL. A meta-analysis was performed on the eight RCTs, with the primary outcome being the diagnosis of a urinary tract infection (UTI) post-SWL. A cost analysis was performed comparing a prophylactic strategy (prophylaxis for every patient and treatment for post-SWL UTIs) with a treatment-only strategy for post-SWL UTIs using various antimicrobial combinations and the median probability of post-SWL UTIs determined by meta-analysis. RESULTS: The incidence of post-SWL UTIs ranged from 0% to 28% in the control group and from 0% to 7.7% in the patients who underwent prophylaxis. Combining the placebo/no-drug treatment arms in the six RCTs by meta-analysis (Bayesian analysis) resulted in a median probability of a post-SWL UTI of 5.7% (95% confidence interval [CI] 3.8% to 8.4%). For the drug treatment arms, the median probability of a UTI was 2.1% (95% CI 0.9% to 3.6%). Relative risk (RR) analysis resulted in an overall RR of post-SWL UTIs with prophylaxis versus without prophylaxis of 0.45 (95% CI 0.22 to 0.93) (P = 0.0005). Depending on the antimicrobial regimen used for prophylaxis and treatment, a prophylactic strategy added minimally to the overall treatment cost of SWL, and proved cost beneficial when taking into consideration serious UTIs requiring inpatient treatment. CONCLUSIONS: A policy of antibiotic prophylaxis prior to SWL in patients with sterile pretreatment urine cultures is efficacious in reducing the rate of post-SWL UTIs. Discounting inpatient episodes for sepsis and acute pyelonephritis, however, the strategy is not cost-effective. In contrast, using literature-derived incidence estimates for post-SWL urosepsis or pyelonephritis necessitating inpatient treatment, prophylaxis becomes both efficacious and cost-effective, and thus constitutes a dominant strategy.

The Hytrin Community Assessment Trial study: a one-year study of terazosin versus placebo in the treatment of men with symptomatic benign prostatic hyperplasia. HYCAT Investigator Group.

OBJECTIVES: To determine the clinical effectiveness and safety of alpha(1)-blockade therapy versus placebo in the treatment of men with moderate to severe symptoms of prostatism in a community-based population under usual care conditions. METHODS: The Hytrin Community Assessment Trial is a prospective, placebo-controlled, randomized, double-blinded, 1-year clinical trial, conducted at 15 academic medical centers (regional sites) and 141 private urology practices (satellite sites). A total of 2084 men at least 55 years old with moderate to severe symptoms of benign prostatic hyperplasia (BPH) as determined by an American Urological Association (AUA) Symptom Score (AUA-SS) of 13 or more points and a bother score (AUA-BS) of 8 or more were enrolled. Randomized patients at regional sites were required to have a peak urinary flow rate less that 15 mL/s with voided volume of at least 150 mL. Treatment with terazosin was initiated with 1 mg daily for 3 days, followed by 2 mg daily for 25 days. Thereafter, patients were titrated stepwise to 5 or 10 mg if they failed to achieve a 35% or greater improvement in the AUA-SS. Primary outcome measures were AUA-SS, AUA-BS, BPH Impact Index (BII), disease-specific quality of life (QQL) score, and treatment failure as defined as discontinuation due to persistent or worsening symptoms or need for surgical intervention for BPH. Secondary outcome measures were peak urinary flow rate and postvoid residual urine volume. RESULTS: AUA-SS (0 to 35 point scale) improved from a baseline mean of 20.1 points by 37.8% during terazosin (n=976) and by 18.4% during placebo (n=973) treatment (P<0.001). Similarly, statistically superior improvements were observed in regard to the AUA-BS, BII, and the QQL score in the terazosin-treated patients. Peak urinary flow rate improved from a baseline of 9.6 mL/s (both regional treatment groups) by 2.2 mL/s in the terazosin group (n=137) and by 0.7 mL/s in the placebo group (n=140) (P< or = 0.05). Treatment failure occurred in 11.2% of terazosin- and 25.4% of placebo-treated patients (P<0.001; Kaplan-Meier adjusted withdrawal rates of 365 days). Withdrawal from study drug treatment due to adverse events occurred in 19.7% of terazosin- and 15.2% of placebo-treated patients (P<0.001). CONCLUSIONS: Terazosin given once daily in a dose ranging from 2 to 10 mg in community-based urology practices under conditions simulating usual care is effective in reducing the symptoms, perception of bother, and the impairment of QQL due to urinary symptoms in men with moderate to severe symptoms of prostatism. This effect is superior to placebo and maintained over 12 months of follow-up. Clinical research outcome studies in BPH can be conducted in community-based practices, thus simulating as closely as possible "usual care" conditions.

The cost-effectiveness of terazosin and placebo in the treatment of moderate to severe benign prostatic hyperplasia.

OBJECTIVES: To evaluate the cost-effectiveness and functional status effects of terazosin, an alpha(1)-adrenoceptor antagonist, compared with placebo in the treatment of men with moderate to severe, symptomatic, benign prostatic hyperplasia (BPH). METHODS: Prospective, randomized, double-blind, placebo-controlled multicenter trial of 2084 patients was conducted at 15 academic regional centers and 141 community-based satellite centers. Information about the use of health care resources and non-disease-specific functional status measures was collected by a standardized telephone interview of patients at baseline and every month thereafter for 12 months. Other information, such as American Urologic Association (AUA) disease-specific functional status scores, was obtained from the patient study records. Patients had a mean age of 65.7 years (range, 46 to 94), with a clinical diagnosis of BPH. At baseline men had at least moderate BPH symptoms by AUA Symptom score (13 or more) and Bother Score (8 or more). On entry, patients at regional sites had peak urinary flow rates 15 mL/s or less and total voided urine volumes 150 mL or greater. A total of 1053 patients were randomized to terazosin and 1031 to placebo treatment. Primary outcome measures included payments for all direct medical resource consumption (inpatient care, emergency department care, outpatient care, and medications); changes in three AUA disease-specific functional status indicators, (Symptom, Bother, and Quality of Life scores), and non-disease-specific functional status measures (days of work loss, days of customary activity loss, and days of bed rest). RESULTS: Total payments for health care resource (including study drug medication), adjusted to reflect 1000 patients per treatment group, were $3,781,803 and $3,568,263 in the placebo and terazosin groups, respectively. All three AUA disease-specific functional status scores improved significantly more in the terazosin group than in the placebo group. We found no difference between terazosin and placebo in all three nonspecific functional status measures. CONCLUSIONS: Compared with placebo, terazosin therapy for moderate to severe symptomatic BPH results in approximately equivalent payments for direct medical care, better disease-specific functional status improvement, and comparable change in non-disease-specific functional status measures.

The assessment of patient complaints.

The objective documentation of patient symptom level is one of the most essential part of its recommendation for the diagnosis, evaluation, work-up, and eventual treatment of patients with prostatism. The AUA Symptom Score is an appropriate system, and should be adopted as the standard instrument during evaluation and follow-up. However, it should be remembered that the symptoms of BPH are not specific. In fact, age-matched women have similar symptoms and equal severity of symptoms when evaluated with the AUA symptom score instrument (Chai, Belville et al., 1993; Chancellor and Rivas, 1993; Lepor and Machi, 1993). This does not take away from the usefulness of the AUA symptom score which was not developed to diagnose BPH, but rather to measure objectively the severity of symptoms, and to follow the progression or improvement of symptoms following treatment. Thus, disease specificity is not a prerequisite for the usefulness of a symptom score used in this capacity. Additional evaluation by urodynamics may be necessary in selected cases. It should be emphasized that optimal treatment decisions for individual patients will also need to take into account how a given level of symptoms affects that patient's quality of life (bothersomeness).