A European Registry Evaluating Symptomatic Effectiveness of Pharmacologically Treated Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Enlargement: Lessons Learned.

PURPOSE: We evaluated unmet needs of lower urinary tract symptoms-benign prostatic enlargement pharmacological treatment by measuring symptom improvement, persistence and deterioration in real life. A prospective registry was conducted for 24 months in 5 European countries and analyzed by the European Association of Urology Research Foundation. MATERIALS AND METHODS: Previously untreated and treated patients were enrolled to the registry in both primary care and urology referral centers in France, Germany, Italy, Spain and the UK. RESULTS: Overall, 2,175 patients were enrolled with 1,838 analyzed, consisting of 575 previously untreated lower urinary tract symptoms-benign prostatic enlargement patients (no alpha blockers for at least 1 month or no 5-alpha reductase inhibitors for at least 6 months) and 1,263 previously treated patients. During the registry 90% of patients adhered to the prescribed regimen. After 24 months, 70% of previously untreated and 42% of previously treated patients experienced symptom improvement (International Prostate Symptom Score [IPSS] reduction of ≥3 points). Symptomatic patients (IPSS ≥8) remained in both groups (59% in previously untreated and 61% in previously treated), with greater symptom deterioration (IPSS increase ≥3 points) in 18.9% in previously treated vs 7.8% in previously untreated patients. Both clinical lower urinary tract symptoms-benign prostatic enlargement progression and surgery rates were similar in untreated vs treated groups at 16% vs 17% and 5% vs 7%, respectively, at 24 months. CONCLUSIONS: This prospective registry confirmed lower urinary tract symptoms-benign prostatic enlargement pharmacological treatment effectiveness in a real-world setting, with low clinical progression observed in about 1 in 6 patients and lower surgery rates below 1 in 20, by 24 months.

Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years.

INTRODUCTION: Successful outcomes have been reported for the treatment of lower urinary tract symptoms (LUTS) with the prostatic urethral lift (PUL) in a number of clinical investigations. Our aim was to investigate PUL outcomes in patients treated in a day-to-day clinical setting without the rigid exclusion criteria of clinical studies. MATERIALS AND METHODS: We investigated the outcome of the PUL procedure at five German departments during the initial period when PUL was approved for the clinic (10/2012-06/2014). All candidates for transurethral resection of the prostate (TURP) received PUL information and were given the choice of procedures. The only exclusion criterion was an obstructive median lobe. No patients were excluded because of high post-void residual volume (PVR), prostate size, retention history or LUTS oral therapy. Maximum urinary flow (Qmax), PVR, International Prostate Symptom Score (IPSS) and Quality of Life (QOL) were assessed at baseline, 1, 6, 12, and 24 months after surgery. RESULTS: Of 212 TURP candidates, 86 choose PUL. A mean of 3.8 (2-7) UroLift implants were implanted in patients of 38-85 years with a prostate size of 17-111 ml over 57 (42-90) min under general or local anesthesia. Thirty-eight (38.4%) patients had severe BPH obstruction and would have been denied PUL utilizing previously reported study criteria. Within 1 month 74 (86%) reported substantial symptom relief with significant improvements in Qmax, PVR, IPSS, and QOL (p < 0.001) that was maintained within the follow-up. Sexual function including ejaculation was unchanged or improved. No Clavien-Dindo Grad ≥ 2 was reported postoperatively. Eleven (12.8%) patients were retreated over 2 years. Twelve (86%) of 14 patients presenting with chronic urinary retention were catheter free at last follow-up. CONCLUSION: PUL is a promising surgical technique that may alleviate LUTS, even in patients with severe obstruction.

[Avanafil for the treatment of erectile dysfunction in practice. Non-interventional study AVANTI]. / Avanafil zur Therapie der erektilen Dysfunktion in der Praxis : Nicht interventionelle Studie AVANTI.

OBJECTIVE AND METHOD: In the prospective, multicentric, non-interventional AVANTI study, the selection criteria for the PDE-5 inhibitor Avanafil were evaluated and it's acceptance in the treatment of patients with erectile dysfunction was investigated. Data from 1,804 probands with an average age of 58.0 years were analyzed. RESULTS: Doctors and patients most commonly referred to Avanafil as a fast-acting substance (70.6% and 78.6%, respectively). A favorable side-effect profile was more focused when the patient co-decided (62.7%) than if the doctor selected (48.4%). 41.2% of the physicians emphasized the potency, 56.7% of the patients preferred to receive a modern medicine. Doctors and patients assessed the drug as effective and well tolerated.

Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study.

OBJECTIVES: To compare prostatic urethral lift (PUL) with transurethral resection of the prostate (TURP) with regard to symptoms, recovery experience, sexual function, continence, safety, quality of life, sleep and overall patient perception. PATIENTS AND METHODS: A total of 80 patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH) were enrolled in a prospective, randomized, controlled, non-blinded study conducted at 10 European centres. The BPH6 responder endpoint assessed symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation and safety. Additional evaluations of patient perspective, quality of life and sleep were prospectively collected, analysed and presented for the first time. RESULTS: Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Qmax ) were observed in both arms throughout the 2-year follow up. Change in IPSS and Qmax in the TURP arm were superior to the PUL arm. Improvements in IPSS QoL and BPHII score were not statistically different between the study arms. PUL resulted in superior quality of recovery, ejaculatory function preservation and performance on the composite BPH6 index. Ejaculatory function bother scores did not change significantly in either treatment arm. TURP significantly compromised continence function at 2 weeks and 3 months. Only PUL resulted in statistically significant improvement in sleep. CONCLUSION: PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study.

BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. Noninferiority was evaluated using a one-sided lower 95% confidence limit for the difference between PUL and TURP performance. RESULTS AND LIMITATIONS: Preservation of ejaculation and quality of recovery were superior with PUL (p<0.01). Significant symptom relief was achieved in both treatment arms. The study demonstrated not only noninferiority but also superiority of PUL over TURP on the BPH6 endpoint. Study limitations were the small sample size and the inability to blind participants to enrollment arm. CONCLUSIONS: Assessment of individual BPH6 elements revealed that PUL was superior to TURP with respect to quality of recovery and preservation of ejaculatory function. PUL was superior to TURP according to the novel BPH6 responder endpoint, which needs to be validated in future studies. PATIENT SUMMARY: In this study, participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01533038.

Nocturia: state of the art and critical analysis of current assessment and treatment strategies.

This editorial of the topic issue of the World Journal of Urology provides a state of the art on nocturia which includes descriptions of the terminology, epidemiology, health-related quality of life, medical and financial consequences, pathophysiology, assessment tools and treatment strategies of nocturia. This summary also includes a flowchart on the pathophysiology of nocturia with illustration of the various causes of reduced bladder capacity, increased fluid intake or increased diuresis; a flowchart with the key findings of frequency-volume charts to determine the underlying pathophysiology; and a flowchart on the treatment of the various causes of nocturia. The editorial critically discusses current assessment and treatment strategies in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and nocturia. The outcome of nocturia remains hidden in drug trials of patients with LUTS/BPH because nocturia-specific measures were not included. The authors recommend using frequency-volume charts, measurement of the hours of undisturbed sleep, and nocturia-specific quality of life questionnaires (e.g., ICIQ-N or N-Qol) in all future studies in patients with LUTS/BPH and nocturia.

Impact of desmopressin on nocturia due to nocturnal polyuria in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH).

PURPOSE: To evaluate the efficacy of desmopressin on nocturia, quality of sleep (QoS), and health-related quality of life (HRQoL) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and nocturia due to nocturnal polyuria (NP) as the predominant symptom. METHODS: A German observational, multicenter, post-marketing surveillance study including men with LUTS/BPH and nocturia due to NP starting 3 months of desmopressin treatment. RESULTS: In total, 137 patients with a mean of 3.8 nocturnal voids (range 2-7) were included. Desmopressin significantly reduced the mean number of nocturnal voids by 53 %, mean IPSS nocturia question by 50 %, and the mean ratio of night/24-h urine volume by 39 % from baseline to endpoint. The hours of undisturbed sleep significantly increased by 74 %; 71 % of men reported about undisturbed sleep of ≥4 h at study end. Additionally, there was a significant reduction in the Leeds Sleep Evaluation Questionnaire score, indicating a clinically relevant QoS improvement. This was associated with an improved HRQoL, as shown by a significant improvement in both the mean IPSS-QoL question by 43 % and mean ICIQ-N nocturia problem question by 53 %. Concomitant alpha-blocker use had no effect on the efficacy of desmopressin. The incidence of adverse events was low (2.2 %). Hyponatremia was not observed in any patient. The majority of patients and physicians rated the efficacy and tolerability of desmopressin as good/very good. CONCLUSIONS: Desmopressin is an effective and well-tolerated treatment for nocturia due to NP in patients with LUTS/BPH in daily practice under routine conditions.

Nocturia and its impact on health-related quality of life and health care seeking behaviour in German community-dwelling men aged 50 years or older.

PURPOSE: To evaluate the prevalence of nocturia/nocturnal voiding frequency and its impact on overall physical and mental health status in German community-dwelling men and determine which lower urinary tract symptom (LUTS) is responsible for medical consultations in the 2-year follow-up period. METHODS: A sample of German men aged 50-80 years from a community-dwelling study was chosen for re-evaluation 2 years after initial assessment. Men were clinically investigated and completed the International Prostate Symptom Score, American Urology Association-Symptom Problem Index (AUA-SPI), and the Short-Form Health Survey (SF-12). RESULTS: In total, 1,562 men were eligible for analysis. Mean nocturnal voiding frequency was 2.3 for all men and increased with ageing. SF-12 data indicated that physical but not mental health status was lower than in the average population. LUTS severity reduced both physical and mental health status (p < 0.001). Clinically relevant nocturia (≥ 2 voids/night) was present in 43 % of men and reduced both physical and mental health status (p < 0.001), whereas both HRQoL scales were not significantly reduced in men without or only one nocturnal void. In multivariate regression analysis using patient-reported bother (AUA-SPI) from LUTS, only bother from nocturnal voiding was significantly associated with medical consultations in the investigated 2-year follow-up period (odds ratio 2.6; 95 % confidence interval 1.6-4.2; p < 0.001). CONCLUSIONS: Our study confirmed that nocturnal voiding is highly prevalent in community-dwelling men and reduce both physical and mental health status. Bother from nocturnal voiding is the most relevant component of LUTS responsible for medical consultations in German men.

Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies.

PURPOSE: To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride. METHODS: The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted. RESULTS: We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates. CONCLUSION: PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.

Age-stratified normal values for prostate volume, PSA, maximum urinary flow rate, IPSS, and other LUTS/BPH indicators in the German male community-dwelling population aged 50 years or older.

PURPOSE: To establish age-stratified normal values for prostate volume, serum total prostate-specific antigen (PSA) concentration, maximum urinary flow rate (Q (max)), micturition and postvoid residual urine volumes, IPSS, and quality of life. These community-derived values of healthy older men are necessary to correctly judge patients with lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH). METHODS: Analysis of LUTS/BPH-related determinants in community-dwelling men in the city of Herne, Germany after exclusion of subgroups with co-morbidities or co-medications with possible influence on the key items. RESULTS: The analysis is based on 1,763 participants. In these men aged 50-80 years, mean total prostate volume continuously increased from 24 to 38 cc and mean PSA concentration from 1.1 to 2.5 ng/ml. PSA concentration in men with a prostate volume <25 cc also showed a continuous increase with aging, starting at 0.8 in the youngest and ending at 1.9 ng/ml in the oldest age group. Mean Q (max) of free uroflowmetry (from 22.1 to 13.7 ml/s) and mean micturition volume (from 329 to 193 cc) showed a continuous decrease that was dependent on prostate size. Mean postvoid residual urine was nearly unchanged over the age groups at approximately 20-30 cc. Although IPSS increased continuously with aging (from 4 to 7), QoL remained unchanged at 2 over the age groups. Prostate size had a minor impact on IPSS. CONCLUSIONS: Normal values for investigated LUTS/BPH-related determinants and the influence of aging hereon should serve as references during the assessment of Caucasian patients in Europe.

Association of polymorphisms in CYP19A1 and CYP3A4 genes with lower urinary tract symptoms, prostate volume, uroflow and PSA in a population-based sample.

PURPOSE: The known importance of testosterone for the development of benign prostatic hyperplasia (BPH) prompted us to test the hypothesis whether polymorphisms of two genes (CYP19A1 and CYP3A4) involved in testosterone metabolism are associated with clinical BPH-parameters. METHODS: A random sample of the population-based Herne lower urinary tract symptoms cohort was analysed. All these men underwent a detailed urological work-up. Two polymorphisms in the CYP19A1 gene [rs700518 in exon 4 (A57G); rs10046 at the 3'UTR(C268T)] and one in the 3'UTR of CYP3A4 [rs2740574 (A392G)] were determined by TaqMan assay from genomic DNA of peripheral blood. These polymorphisms were correlated to clinical and laboratory BPH-parameters. RESULTS: A total of 392 men (65.4 ± 7.0 years; 52-79 years) were analysed. Mean International Prostate Symptom Score (IPSS; 7.5), Q (max) (15.4 ml/s), prostate volume (31 ml) and prostate specific antigen (PSA) (1.8 ng/ml) indicated a typical elderly population. Both polymorphisms in the CYP19A1 gene were not correlated to age, IPSS, Q (max), prostate volume and post-void residual volume. Serum PSA was higher in men carrying the heterozygous rs10046 genotype (2.0 ± 0.1 ng/ml) than in those with the CC-genotype (1.7 ± 0.2 ng/ml, P = 0.012). Men carrying one a mutated allele of the CYP3A4 gene had smaller prostates (27.0 ± 2.0 vs. 32 ± 0.8 ml, P = 0.02) and lower PSA levels (1.6 ± 0.3 vs. 1.9 ± 0.1 ng/ml). CONCLUSIONS: The inconsistent associations observed herein and for other gene polymorphisms warrant further studies. In general, the data regarding the association of gene polymorphism to BPH-parameters suggest that this disease is caused by multiple rather than a single genetic variant. A rigorous patient selection based on anatomo-pathological and hormonal profile may possible reduce the number of confounders for future studies thus enabling a more detailed assessment of the association between genetic factors and BPH-parameters.

From pathogenesis to prevention of castration resistant prostate cancer.

BACKGROUND: Significant progress in understanding the molecular basis of castration resistant prostate cancer (CRPCa) has been achieved in recent years. Despite this progress, CRPCa still remains a lethal disease. Early detection and prevention of CRPCa may provide a new strategy to improve survival of patients diagnosed with PCa at risk to fail standard androgen deprivation therapy (ADT). METHODS: Herein, we review pathogenetic mechanisms implicated in PCa progression toward castration resistant disease that are detectable in hormone naive PCa to define relevant therapeutic targets for prevention. RESULTS: Upregulation of androgen receptor (AR) expression has been recognized a major determinant for the development of CRPCa. This hypersensitive pathway is further boosted by the increase of intratumoral androgen synthesis. AR mutants bind promiscuous steroids, and may convert AR antagonists to agonists. Various non-hormonal growth factor receptors transactivate the AR, even in absence of androgens (outlaw pathway). Finally, PCa cells can bypass the AR through various mechanisms, including BCL-2, COX-2, neuroendocrine differentiation. Most of these pathogenetic factors involved in the development of CRPCa are detectable in hormone naive PCa tissue even at the time of initial diagnosis, and could be targeted by drugs currently available. CONCLUSIONS: CRPCa is the end-stage of a multifactorial and heterogeneous disease process. Pathogenetic factors responsible for the development of the CRPCa phenotype are detectable in the patient's PCa tissue long before the clinical onset of the disease. This approach provides opportunity for early detection and prevention by targeting pathways relevant for the individual disease process.

Common genetic polymorphisms of AURKA and prostate cancer risk.

PURPOSE: AURKA is a centrosome-associated serine/threonine kinase involved in mitotic chromosomal segregation. The AURKA gene is located on chromosome 20q13, also known as HPC20 prostate cancer susceptibility locus. Therefore, we investigated in this Caucasian case-control study two single nucleotide polymorphisms (SNPs) of the AURKA gene, rs8173 located in the 3'-untranslated region (G1891C) and rs2273535 in exon 5 (Phe31Ile), and their association with prostate cancer risk. METHODS: DNA was extracted from peripheral blood of 824 prostate cancer patients and 1,081 control patients with benign prostatic hyperplasia (BPH). Genotypes were determined using 5'-nuclease TaqMan assays. Multiple logistic regressions were performed to calculate odds ratios (OR) and confidence intervals (CI) and to adjust for confounders. RESULTS: The odds ratios calculated relative to the wild-type were for the homozygous polymorphic genotypes 1.11 (95% CI = 0.70-1.76) for rs8173 and 1.32 (95% CI = 0.76-2.31) for rs2273535, respectively. Stratified analyses according to Gleason score showed also no statistically significant association for the investigated polymorphisms and prostate cancer risk. CONCLUSIONS: The two investigated SNPs in AURKA were not found to be associated with prostate cancer risk. Other common SNPs of AURKA should be investigated in further studies because of its location on a prostate cancer susceptibility locus.

The evolving role of oestrogens and their receptors in the development and progression of prostate cancer.

CONTEXT: Oestrogens were proven effective in the hormonal treatment of advanced prostate cancer (PCa) >60 yr ago and are still used as second-line hormonal therapy. Paradoxically, oestrogens might also be involved in the development and progression of PCa. OBJECTIVE: To examine mechanisms of how oestrogens may affect prostate carcinogenesis and tumour progression. EVIDENCE ACQUISITION: Recent data obtained from animal, experimental, and clinical studies were reviewed. EVIDENCE SYNTHESIS: The human prostate is equipped with a dual system of oestrogen receptors (oestrogen receptor alpha [ERalpha], oestrogen receptor beta [ERbeta]) that undergoes profound remodelling during PCa development and tumour progression. In high-grade prostatic intraepithelial neoplasia (HGPIN), the ERalpha is upregulated and most likely mediates carcinogenic effects of estradiol as demonstrated in animal models. Preliminary clinical studies with the ERalpha antagonist toremifene have identified the ERalpha as a promising target for PCa prevention. The partial loss of the ERbeta in HGPIN indicates that the ERbeta acts as a tumour suppressor. The ERbeta is generally retained in hormone-naïve PCa but is partially lost in castration-resistant disease. The progressive emergence of the ERalpha and the oestrogen-regulated progesterone receptor (PR) during PCa progression and hormone-refractory disease suggests that these tumours can use oestrogens and progestins for their growth. The TMPRSS2-ERG gene fusion recently reported as a potentially aggressive molecular subtype of PCa is regulated by ER-dependent signalling. TMPRSS2-ERG expression has been found to be increased by ERalpha agonist (oestrogens) and decreased by ERbeta agonists. CONCLUSIONS: Oestrogens and their receptors are implicated in PCa development and tumour progression. There is significant potential for the use of ERalpha antagonists and ERbeta agonists to prevent PCa and delay disease progression. Tumours equipped with the pertinent receptors are potential candidates for this new therapeutic approach.

The efficacy of drugs for the treatment of LUTS/BPH, a study in 6 European countries.

OBJECTIVES: This paper profiles the usage and effectiveness of various LUTS/BPH drugs in real-life practice. METHOD: The TRIUMPH study recorded the treatment and outcomes of 2351 newly-presenting LUTS/BPH patients in 6 European countries over a 1-year follow-up period. At each visit the clinician recorded the treatment, co-morbidities, complications and drugs prescribed, and the patient completed an IPSS questionnaire. The results were analysed using change in IPSS as the primary outcome measure. RESULTS: Over the study period 74.9% of patients were prescribed medication, the majority (83% of those medicated) were prescribed only a single drug. Tamsulosin was the most commonly prescribed drug in all countries (38% of medicated cases), although with national variation from 24% in Poland to 70% in Italy. The alpha-blockers were the most effective, with a mean reduction of 6.3 IPSS points. Finasteride was slightly less effective (4.1 points). Significant improvements were seen in 43% of patients on phytotherapy with Serenoa repens or Pygeum africanum compared to 57% of those on finasteride and 68% on alpha-blockers. The only combination therapy found to produce a statistically significant improvement over the use of individual drugs was finasteride+tamsulosin (8.1 points compared to 6.7 for tamsulosin alone and 4.2 for finasteride alone). CONCLUSIONS: All drug treatments showed some improvement over watchful-waiting for most patients over the study period: the alpha-blockers were found to be the most effective. There were marked national differences in prescribing patterns, both in individual drug choice and in the use of combination therapies.

Characteristics of patients presenting with LUTS/BPH in six European countries.

OBJECTIVES: Knowledge of the clinical profile of the population with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) is important for health care management, impacting on manpower requirements, pharmacologic demands and health service costs. Data collected by the TransEuropean Research Into the Use of Management Policies for LUTS suggestive of BPH in Primary Health care project were used to profile 4979 patients from six European countries newly presenting with LUTS/BPH to general practitioners or office-based urologists. METHODS: At recruitment, the clinician completed a questionnaire detailing the treatment provided, examination results, and covariates including age, initial symptom severity and comorbidities. The patient completed an International Prostate Symptom Score/quality-of-life questionnaire. RESULTS: The majority of patients (77%) sought medical advice because of the bothersomeness of their symptoms, and presented at ages between 58 and 71 years. Small but statistically significant differences among countries were found in initial symptom severity, initial quality of life and age at diagnosis, but these are not thought to be clinically significant. There were marked national differences in patient management, with, for example, 10% of patients in France reporting no examinations, compared with 0.5% in Poland, while free-flow measurements varied from less than 1% in France to 35% in Poland. CONCLUSIONS: Patient heterogeneity does not explain the differences in patient management among countries, which undoubtedly is the result of differences in health care traditions, infrastructure and socioeconomic factors, as well as patient preference.

Prostate size and PSA serum levels in male patients with spinal cord injury.

OBJECTIVES: To evaluate prostate size and serum prostate-specific antigen (PSA) levels in male patients with spinal cord injury (SCI). As a result of improved medical care, the life expectancy in patients with SCI today equals the life expectancy of the general population. Therefore, male patients with SCI are likely to develop benign prostatic hyperplasia or prostate cancer. Although animal experiments indicate that neurogenic factors play an important role in prostate growth, the influence of these factors is not well examined in humans. METHODS: The data of 100 male patients with SCI and 575 noninjured men were evaluated. The inclusion criteria were age older than 35 years and SCI for longer than 2 years. The exclusion criteria were previous prostate surgery, acute urinary tract infection, and bladder or prostate cancer. PSA was measured by an immunoenzymatic assay, and the prostatic volume was assessed by transrectal ultrasonography. For analysis, patients were grouped according to age. RESULTS: With increasing age, the mean prostate volume increased in the patients with SCI and in the control group. The mean PSA level increased with age in the control group and to a far lesser extent in the patients with SCI. Neither for the entire cohort nor for the subgroups delineated by age were the differences in mean PSA level and mean prostate volume between patients with SCI and the control group statistically significant. CONCLUSION: Prostate growth is detectable in patients with SCI. Although there is a tendency toward a lower prostate volume and lower serum PSA level in patients with SCI, the differences were not statistically significant. According to our results, the reference ranges for PSA levels are not vastly different from the general reference ranges.