The predictive value of baseline variables in the treatment of benign prostatic hyperplasia using high-energy transurethral microwave thermotherapy

OBJECTIVE: To evaluate the combination of patient age, prostate size, grade of outlet obstruction and total amount of energy, all independent predictive variables of treatment outcome in patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) treated with high-energy transurethral microwave thermotherapy (HE-TUMT), and thus provide nomograms for predicting treatment outcome after HE-TUMT. PATIENTS AND METHODS: Between October 1993 and July 1996, 247 patients with LUTS and BPH were treated with HE-TUMT using the Prostatron device, software version 2.5 (EDAP Technomed, Lyon, France). The World Health Organisation Response Evaluation Criteria were used to evaluate the outcome. Patient age, prostate volume, total amount of energy and grade of outlet obstruction were categorized using the Akaike information criterion (AIC). The probabilities of a good/intermediate vs a poor response at 26 weeks according to the AIC were calculated. RESULTS: Nomograms are presented providing the estimated probability (95% confidence interval) for a good/intermediate response of the evaluation of the International Prostate Symptom Score at 26 weeks by categories of prostate volume, total amount of TUMT energy and age, and of maximum urinary flow rate by categories of bladder outlet obstruction (linear passive urethral resistance ratio, linPURR) and total amount of energy, and of linPURR by categories of prostate volume and total amount of energy. The total amount of energy appeared to have the most impact in the prediction of good/intermediate and poor response in all three response evaluation criteria. CONCLUSIONS: These nomograms may assist urologists in making clinical recommendations for the treatment of men with LUTS and BPH using HE-TUMT.     

Neoadjuvant and adjuvant alpha-blockade improves early results of high-energy transurethral microwave thermotherapy for lower urinary tract symptoms of benign prostatic hyperplasia: a randomized, prospective clinical trial

OBJECTIVES: Improved long-term results with respect to symptoms, voiding function, and quality of life (QOL) in patients with lower urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH) are achieved with targeted high-energy transurethral microwave thermotherapy (TUMT) compared with alpha-blocker treatment alone. However, maximal improvement after TUMT is not attained until 3 to 6 months after treatment. Measures to provide earlier symptom relief and improved voiding function and QOL would add to the clinical utility of TUMT. The objective of the present study was to determine whether neoadjuvant and adjuvant alpha-blockade is capable of accelerating a post-TUMT decrease in LUTS of patients with BPH. METHODS: In this randomized, prospective study of 81 patients with LUTS of BPH, 41 underwent TUMT with neoadjuvant and adjuvant tamsulosin (0.4 mg daily) treatment, and 40 had TUMT alone. International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), and QOL score were determined before treatment and at periodic intervals thereafter up to 12 weeks after TUMT. RESULTS: Mean IPSS values in the TUMT plus tamsulosin group at 2 weeks (14.0, 95% confidence interval [CI] 13.1 to 14.9) and 6 weeks (8.6; 95% CI 7.7 to 9.5) were 15% and 24% lower, respectively, than those at 2 weeks (16.5, 95% CI 15.6 to 17.4) and 6 weeks (11.3, 95% CI 10.4 to 12.2) in the TUMT-alone group (P<0.0005). However, by the final evaluation at 12 weeks, no significant difference between the groups in mean IPSS was evident. A similar temporal pattern of difference between the two study groups was also observed in QOL score. No significant between-group difference in mean Qmax was evident after TUMT. Urinary retention 1 week or more in duration occurred in 5 (12%) of 40 TUMT-alone group patients compared with 1 (2%) of 41 TUMT plus tamsulosin group patients. CONCLUSIONS: Neoadjuvant and adjuvant alpha-blocker treatment results in significantly greater early symptom reduction and QOL score improvement after TUMT, adding to the clinical utility of this minimally invasive treatment modality. In addition, post-TUMT complications such as urinary retention may be reduced.     

Is the ratio of transition zone to total prostate volume higher in African-American men than in their Caucasian or Hispanic counterparts?

OBJECTIVE: To determine if the transition zone index (TZI, the ratio between transition zone volume, TZV, and total prostate volume, as estimated by transrectal ultrasonography, TRUS) differs among African-American (AA), Hispanic and Caucasian men. PATIENTS AND METHODS: The study group consisted of 104 age-matched men (36 AA, 34 Hispanic and 34 Caucasian) with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). A control group of 55 age-matched men, equally distributed among the three ethnic groups, but with no BPH (based on a digital rectal examination) were also evaluated. All men completed the International Prostate Symptom Score (IPSS) and a measurement of peak urinary flow rate (Qmax), prostate volume and TZV (by TRUS) and the TZI calculated. RESULTS: In the control group, the mean prostate volume was 20.9, 18.2 and 19.8 mL, the TZV 6.9, 4.9, and 5.4 mL and the TZI 0.33, 0.27 and 0.25 for AA, Hispanic and Caucasian men, respectively. The TZI was significantly higher in AA than in either Hispanic or Caucasian men (P < 0.03). Although there were no differences in prostate volume among the three ethnic groups with BPH, the mean (SD) TZV and TZI were significantly higher in AA men than in either their Hispanic or Caucasian counterparts, at 15.8 (7.6) mL and 0.43, 12.7 (8.1) mL and 0.37, and 13.8 (6.7) mL and 0.37, respectively. For all groups, age correlated with the IPSS (r = 0.22, P < 0.04); the mean (SD) IPSS was 14.3 (5.7), 10.2 (2.9) and 10.6 (4.9) for AA, Hispanic and Caucasian men, respectively. There was no correlation between the IPSS and either prostate volume or TZV, but there was a strong correlation with the TZI (r = 0.29, P < 0.01), regardless of race. CONCLUSIONS: These results suggest that AA men have a greater TZV and a higher TZI than their Caucasian or Hispanic counterparts, regardless of the presence of lower urinary tract symptoms. Studies are underway to determine if these differences are clinically significant and correlate with either subjective and/or objective parameters of BPH.     

Loss of Bcl-2 expression correlates with tumour recurrence in colorectal cancer

OBJECTIVE: To analyse the efficacy, correlations and adverse-event profile of placebo therapy from the initial placebo run-in period to beyond 2 years of treatment. PATIENTS AND METHODS: The effects of placebo therapy on prostate size, maximum urinary flow rate (Qmax) and symptoms were analysed, and adverse drug experiences documented, for a period of 25 months in 303 patients randomized to the placebo arm of a controlled trial evaluating finasteride in the treatment of BPH (the Canadian PROSPECT study). RESULTS: For all variables, the values during follow-up were significantly different from baseline (P < or = 0.001). Transrectal ultrasonography confirmed a progressive increase in prostate volume over 25 months (+8.4%) but Qmax improved for the first 5 months (to 1.4 mL/s over baseline) and remained 1.0 mL/s more than baseline at 25 months. The total symptom score improved by -2.9 points in the first 2 months on placebo and was ultimately 2.3 points below baseline at 25 months. The extent of the placebo response for symptoms (r=0.08, P=.180) and Qmax (r=0.04, P=0.550) was independent of age, but the response correlated with the initial severity of symptoms (r= -0.394, P < or = 0.001) and initial Qmax (r= -0.134, P=0.023). Patients with a prostate of < or = 40 mL had a clinically more important placebo response than those with larger prostates. In all, 246 patients (81.2%) reported adverse events thought to be secondary to placebo therapy. The most common complaint was urogenital (40.3%), specifically impotence (6.3%) and decreased libido (6.3%); 13.2% of patients discontinued placebo therapy because of significant adverse reactions. CONCLUSIONS: Placebo therapy rapidly produces a significant improvement in Qmax and symptoms of BPH but also causes clinically important adverse effects. The beneficial effect fades but remains after 2 years.     

Comparison of tamsulosin with alfuzosin in the treatment of patients with lower urinary tract symptoms suggestive of bladder outlet obstruction (symptomatic benign prostatic hyperplasia). The European Tamsulosin Study Group

OBJECTIVE: To compare the efficacy and tolerability of the alpha 1 A-subtype selective drug tamsulosin with the nonsubtype-selective agent alfuzosin in the treatment of patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), often termed symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: The study comprised 256 patients with benign prostatic enlargement and LUTS suggestive of BOO (symptomatic BPH) who received tamsulosin 0.4 mg once daily or alfuzosin 2.5 mg three times daily during 12 weeks of treatment. The response was assessed by measurements of maximum urinary flow rate (Qmax), a symptom score (Boyarsky) and blood pressure at regular intervals. RESULTS: Tamsulosin and alfuzosin produced comparable improvements in Qmax and total Boyarsky symptom score. Both treatments were well tolerated with respect to adverse events. Tamsulosin had no statistically significant effect on blood pressure compared with baseline but alfuzosin induced a significant reduction in both standing and supine blood pressure, compared with baseline (P < 0.05). CONCLUSION: Tamsulosin is the first adrenoceptor antagonist that is selective for the alpha 1 A-subtype; this specificity may explain its lack of effect on blood pressure compared with alfuzosin, an agent that is not receptor subtype specific. Moreover, this finding may partly explain why tamsulosin, in contrast to other currently available alpha 1-adrenoceptor antagonists, can be administered without dose titration. Another advantage compared with alfuzosin (and prazosin) is the once-daily dosing regimen of tamsulosin.     

Efficacy and safety of luteinizing hormone-releasing hormone antagonist cetrorelix in the treatment of symptomatic benign prostatic hyperplasia

As the life expectancy for men increases, more cases of benign prostatic hyperplasia (BPH) will be expected. Symptomatic BPH causes morbidity and can lower the quality of life. We investigated whether short term administration of the LH-releasing hormone antagonist cetrorelix could provide an improved treatment for men with BPH. Thirteen patients with moderate to severe symptomatic BPH were treated with cetrorelix (5 mg, s.c., twice daily for 2 days followed by 1 mg/day, s.c., for 2 months). Patients were evaluated at baseline, during treatment, and up to 18 months after therapy. We determined the effects of cetrorelix on the International Prostate Symptom Score (IPSS), Quality of Life score, sexual function, prostate size, uroflowmetry, and hormonal levels. Treatment with cetrorelix produced a decline of 52.9% (P < 0.0001) in IPSS, a 46% improvement in the Quality of Life score (P < 0.001), a rapid reduction of 27% (P < 0.006) in prostatic volume, and an increase in peak urinary flow rates by 2.86 mL/s. Serum testosterone fell to castrate levels on day 2, but was inhibited only by 64-74% during maintenance therapy, and after cessation of treatment returned to normal. During long term follow-up, most patients continued to show a progressive improvement in urinary symptoms (decline in IPSS from 67% to 72% at weeks 20 and 85, respectively) and an enhancement of sexual function, and prostatic volume remained normal. Our study demonstrates that in patients with symptomatic BPH, treatment with cetrorelix is safe and produces long term improvement.     

Effect of low-phosphorus milk for infants on blood and urine calcium and phosphorus parameters in neonates

OBJECTIVE: To determine the variation in repeated measurements of post-void residual urine volume (PVR), determined by transabdominal ultrasonography (TAUS), within an individual over time (test-retest reliability). PATIENTS AND METHODS: Forty men with symptomatic benign prostatic hyperplasia and awaiting transurethral resection of the prostate were studied over 3 months. Each underwent TAUS to determine both pre- and post-micturition residual volumes on six occasions within the study period. RESULTS: Although one-third of the patients had approximately constant residual volumes (variation in range < 120 mL), two-thirds had wide intra-individual variations over time (variation in range 150-670 mL). The values were log transformed to give a normal distribution and subjected to analysis of variance; there was a wide variation between and also within individuals. The larger the mean PVR, the larger was the overall variation in time. For those with a mean PVR of < 100 mL, the variation was less marked and these patients showed a more consistent test-retest repeatability. CONCLUSIONS: Although the PVR determined by TAUS may be useful to indicate aspects of bladder dysfunction or outlet obstruction, the wide variation in repeated measurements in the same individual limits its use for any clinical purpose that requires repeated assessment, e.g. in monitoring the response to treatment. There is poor test-retest reliability and PVRs cannot be determined reliably from a single measurement.     

Maternal smoking during pregnancy and the risk of conduct disorder in boys

(BACKGROUND): We studied the clinical efficacy of transurethral microwave thermotherapy (TUMT) using Endotherm UMW system (OLYMPUS). (METHODS): TUMT was performed in 28 patients with benign prostatic hyperplasia (BPH). Three patients of them were catheterized because of urinary retention. The treatment was performed in a single session for an hour. The urethral surface temperature was set at 39 degrees C, and the coolant flow of the urethral applicator (21 Fr balloon catheter) was set at 30 ml/min, to heat up the broad area of the prostate up to 45 degrees C. The clinical efficacy was evaluated by analyzing subjective responses, using the International Prostate Symptom Score (I-PSS) scale (S) and QOL score (L), and objective responses, using peak urinary flow rate (Qmax), average flow rate (Qave), residual urine volume and prostate volume following the treatment. (RESULTS): At 24 weeks after the treatment, significant improvement were observed in S score (41%), L score (37%), Qmax (53%) and Qave (62%). Although there was no significant decrease in residual urine and prostate volume. The three patients, with a catheter indwelled because of urinary retention, were all free of the catheter within 4 weeks after the treatment. During and after the treatment, no severe adverse effects, including transient urinary retention needed for indwelling a catheter, was detected. (CONCLUSION): A single session of TUMT by Endotherm UMW considered to be safe and useful for symptomatic BPH patients, even who are not indicated for transurethral resection of the prostate (TUR-P) because of underlying disorders.     

Maximum flow rate--the single uroflowmetric parameter in clinical trials for benign prostatic hyperplasia?

BACKGROUND: Uroflowmetry parameters should be examined for both reliability and optimal test conditions in patients with benign prostatic hyperplasia (BPH), since the difference between one pre- and one post-intervention uroflow rate is usually evaluated in clinical trials of BPH. PATIENTS AND METHODS: Reproducibility of maximum flow rate (Qmax) or its modified forms, and the effects of urinary volume on the reproducibility were examined in terms of Spearman's correlation coefficient (r) in 67 BPH patients. RESULTS: Qmax had a higher r (0.672) as compared to other uroflow rates, such as mathematically modified forms of Qmax and adjusted values of Qmax on nomograms. Reliability was improved by bladder instillation (r = 0.811) or when voided volume was > or = 150 ml or the ratio of volumes was < 2.0 (r = 0.690-0.736). CONCLUSION(S): Qmax, preferably performed with urinary volumes of more than 150 ml or the ratio of volumes less than 2.0, is the most practical single parameter at present in the comparison of two uroflowmetric tests in BPH treatment.     

Extraorganic hepatic artery aneurysm: failure of transcatheter embolization

BACKGROUND: We evaluated the safety and efficacy of transurethral electrovaporization of the prostate (TVP) as a new alternative treatment for patients with benign prostatic hyperplasia. METHODS: A total of 22 patients with symptomatic benign prostatic hyperplasia, including 4 with urinary retention, underwent TVP. If enough of a cavity was not created after 60 minutes of vaporization, transurethral resection of the prostate (TURP) was performed successively. International Prostate Symptom Score (I-PSS) with quality-of-life index, maximum flow rate, and postvoid residual volume were measured at baseline and at 2 weeks, 1, 3, and 6 months. A pressure-flow study was performed at baseline and at 3 or 6 months after surgery. RESULTS: TURP was required in 10 of 22 patients. At 6 months, mean I-PSS decreased from 20.0 to 5.2, quality-of-life index decreased from 4.6 to 1.1, mean maximum flow rate increased from 6.9 to 16.7 mL/s, and postvoid residual volume decreased from 152 to 32 mL. Detrusor pressure at maximum flow decreased from 108 to 39 cm H2O, with a significant relief of bladder outlet obstruction in 93% of the patients. Mean decrease in hematocrit was 4.4%, and in serum sodium, 4.8 mEq/L. None of the patients required transfusions or had TUR syndrome. A urethral stricture and a severe stress incontinence developed in 1 patient. CONCLUSION: TVP seems to be a safe and effective alternative to a standard TURP associated with fewer intraoperative complications. Although preliminary clinical results have been promising, further study is necessary to establish long-term efficacy and safety of this procedure.     

Validation of a harmonized Spanish version of the IPSS: evidence of equivalence with the original American scale. International Prostate Symptom Score

OBJECTIVES: To validate the use in Spain of a linguistically harmonized Spanish version of the International Prostate Symptom Score (IPSS Sp), and to compare it with the original American scale (IPSS Am). METHODS: Validity and reliability were studied in 59 patients with benign prostatic hyperplasia (BPH) (age >50 years) and 68 control subjects without BPH (age 18 to 49 years). Construct validity was assessed by correlating IPSS Sp scores with the EuroQol-5D (EQ-5D), the Psychological General Well-Being Index (PGWBI), and item 8 (quality of life) of the IPSS. Discriminatory power was assessed by calculating the area under the receiver operating characteristic (ROC) curve. Reliability was evaluated using the test-retest method, and internal consistency was assessed using Cronbach's alpha. Sensitivity to change was expressed as the effect size in preintervention versus postintervention scores in 26 additional patients with BPH (age >50 years) who underwent transurethral resection of the prostate. RESULTS: Correlations of the IPSS Sp were -0.07 to 0.36 with EQ dimensions; -0.29 with the EQ visual analogue scale score; 0.14 to 0.41 with PGWBI dimensions; and 0.72 with item 8 of the IPSS. ROC area was 0.95 +/- 0.02 (standard error). Using a cutoff point of 7, sensitivity was 83% and specificity was 98%. Test-retest reliability was 0.92 and Cronbach's alpha was 0.79. Mean preoperative and postoperative IPSS Sp scores were 25.56 and 8.48, respectively (P < 0.001 ). Overall effect size was 2.52. These results are similar to those of the original American scale. CONCLUSIONS: This Spanish translation of the IPSS is valid, reliable, and sensitive to clinical change and has demonstrated equivalent psychometric properties to the original American instrument. Scores obtained with the two instruments can therefore be reliably compared and aggregated when statistically appropriate.     

Reconstruction of anterior cruciate ligament using the doubled tendon graft technique: an experimental study in rabbits

BACKGROUND: Mepartricin, a semisynthetic polyene derivative with a favorable effect on urethro-prostatic function, was clinically evaluated, adopting the diagnostic and research criteria recommended by the First International Consultation on BPH. METHODS: A multicenter, randomized, double-blind, parallel-group study compared mepartricin 40 mg/daily to placebo in the treatment of 196 patients with newly diagnosed BPH and mild-to-moderate symptomatology. International Prostate Symptom Score (I-PSS), quality of life (QoL) index and maximum urinary flow-rate (Qmax) were determined every 4 weeks for 6 months; postvoiding volume, prostate volume, and prostate-specific antigen (PSA) were assessed after 3 and 6 months of therapy. RESULTS: Mepartricin was shown to determine a statistically significant improvement over placebo in I-PSS and QoL index from month 2 onwards, and a significant linear increase in Qmax over the study period. At month 6, the improvement in the mepartricin and placebo groups in I-PSS, QoL index, and Qmax was 6.3 (standard error (SE) 0.51) and 4.2 (SE 0.60) points (P = 0.003), 0.99 (SE 0.14) and 0.62 (SE 0.12) points (P = 0.036), and 2.7 (SE 0.46) and 1.2 (SE 0.46) ml/sec (P = 0.051), respectively. No significant differences were noted in postvoiding residual volume, prostate volume, or PSA. Mepartricin tolerability was good, showing no adverse events on sexual function. CONCLUSIONS: Mepartricin proved to be an effective treatment of benign prostatic hyperplasia, determining an improvement in symptoms, quality of life, and peak urinary flow.     

Factors related to delayed treatment and posttreatment symptom severity in Taiwanese patients with benign prostatic hyperplasia

We evaluated the sociodemographic and clinical factors of delayed treatment and posttreatment symptom severity in outpatients with benign prostatic hyperplasia (BPH). The study included 146 BPH patients treated at the National Taiwan University Hospital in early 1997. All patients were treated with alpha-adrenergic antagonists or finasteride for at least 2 weeks. A questionnaire based on Andersen's Health Behavior Model was used to assess various sociodemographic features, while the pre- and posttreatment symptoms severity was rated according to the International Prostate Symptom Score (IPSS). Multiple logistic regression was used to assess the associations of these factors with delayed treatment and posttreatment symptom severity. Subjects who had recently quit smoking or were blue-collar workers tended to delay treatment, while those who chose a medical center as the care provider for chronic diseases tended to be less likely to delay treatment. However, none of these associations were statistically significant. No enabling factors (income, insurance) or need factors (symptom scores) evaluated were associated with delayed treatment. Predisposing factors associated with higher posttreatment symptom severity were delayed treatment (over 12 months) (adjusted odds ratio [OR]: 2.67, 95% confidence interval [CI]: 1.16-6.16), quitting smoking (adjusted OR: 4.47, 95% CI: 1.34-14.94), and having never smoked (adjusted OR: 3.73, 95% CI: 1.15-12.11). Subjects with severe pretreatment symptoms were far more likely than subjects with mild pretreatment symptoms to have severe symptoms after treatment (adjusted OR: 52.69, 95% CI: 54.46-621.90). Our findings, though based on a limited number of subjects, suggest sociodemographic factors rather than objective clinical attributes (prostate specific antigen level, prostate volume, and urodynamic results) are associated with delayed treatment in Taiwanese men with BPH. Both pretreatment symptom severity and sociodemographic factors are related to posttreatment symptom severity.     

Evaluation of patients with bladder outlet obstruction and mild international prostate symptom score followed up by watchful waiting

OBJECTIVES: To examine the variability of bladder outlet obstruction and mild lower urinary tract symptoms in patients with benign prostatic hyperplasia (BPH) followed up by watchful waiting. METHODS: The International Prostate Symptom Score (IPSS) has four questions related to voiding symptoms and three related to filling symptoms. Scores of 0 to 7, 8 to 19, and 20 to 35 represent mild, moderate, and severe symptoms, respectively. Over a period of 36 months the IPSS questionnaire was administered to 479 patients 50 to 81 years old (mean age 63) with BPH. A pressure-flow study was used to determine the presence of bladder outlet obstruction. On the basis of their scores, the patients were classified into 50 with mild, 227 with moderate, and 202 with severe symptoms. In the present study only patients with a mild score were analyzed. RESULTS: Of 50 patients with mild symptoms, 16 (32%) had bladder outlet obstruction. After a period of 9 to 22 months (mean 17) of watchful waiting, these 16 patients were reviewed. Twelve (75%) of the 16 had bladder outlet obstruction reconfirmed by pressure-flow studies, and 3 (18.8%) of 16 had increased symptoms (moderate symptomatic) and underwent treatment (1 began pharmacologic treatment, and 2 chose transurethral resection). A total of 4 (25%) of 16 patients still had mild voiding disturbances and refused the second urodynamic evaluation. The remaining 34 patients with no obstruction had annual routine follow-up and had persistent mild symptom scores and normal uroflowmetric results. These patients did not undergo another pressure-flow evaluation. CONCLUSIONS: A pressure-flow study is routinely avoided in patients with a mild IPSS. From symptoms alone it was not possible to diagnose bladder outlet obstruction in these patients. Pressure-flow studies and symptom profiles measure different aspects of the clinical condition. After a mean follow-up of 17 months of watchful waiting, 13 (81.2%) of 1 6 patients were clinically stable. Because the need for therapy is dictated by quality of life, it is difficult to propose treatment for patients with minimal symptoms, even in the presence of bladder outlet obstruction.     

Should we screen for asymptomatic left ventricular dysfunction to prevent heart failure?

OBJECTIVE: To evaluate quantitatively and qualitatively the degree of sexual dysfunction in an unselected population of men attending a prostate-assessment clinic using a sexual-function inventory, and to ascertain the degree of correlation between sexual dysfunction, urinary symptoms and age. PATIENTS AND METHODS: In all, 168 men with symptomatic BPH attending a prostate assessment clinic were investigated prospectively using the International Prostate Symptom Score (IPSS), BPH Impact Index (BPHII), a measurement of urinary flow rate and residual urine volume, and a sexual function questionnaire. The results were assessed using Spearman's rank order correlation to discern any correlations between the measured variables. RESULTS: The data from 140 patients were available for analysis; of these, low scores were obtained in 59% for sexual drive, in 56% for erections (with 46% of men satisfying the National Institute of Health criterion for impotence) and in 38% for ejaculation. There was a statistically significant rank order correlation between age and the sexual symptom scores for each of the three categories (sexual drive, erection and ejaculation), but no correlation between age and the problem assessment scores for these domains, suggesting that the older patients are just as bothered by their sexual dysfunction as the younger men. Furthermore, the BPHII scores correlated weakly but significantly with all aspects of sexual function, including overall sexual satisfaction, in contrast to the poor correlation seen with the total IPSS and sexual function scores. CONCLUSION: There is a significant number of patients with symptomatic BPH who have sexual dysfunction, with the proportion increasing with advancing age and with the older men still showing a high degree of bother from their symptoms. Sexual function scores were better correlated with BPHII scores than with the total IPSS, although some of the individual IPSS questions correlated well.     

Efficacy and acceptability of tadenan (Pygeum africanum extract) in the treatment of benign prostatic hyperplasia (BPH): a multicentre trial in central Europe

Pygeum africanum extract is available as Tadenan in many countries, including those in central and eastern Europe, for the treatment of mild to moderate BPH. Its efficacy and acceptability have been demonstrated in numerous open and placebo-controlled studies in large populations. The present open three-centre efficacy and safety study was conducted according to common protocol at urology clinics in the Czech and Slovak Republics and in Poland, in order to confirm the therapeutic profile of Pygeum africanum in conditions of daily practice, using International Prostate Symptom Score (IPSS) and flowmetry assessments. Men aged 50-75 years and in compliance with the selection criteria (including IPSS > or = 12, quality of life (QoL) score > or = 3, and maximum urinary flow < or = 15 ml/s) were first examined then recalled after two weeks during which no treatment was provided (washout and check of stability). If still compliant, they were entered at this point into a two-month period of treatment with Pygeum africanum extract 50 mg twice daily. There followed a further one-month period without treatment, the objective being to evaluate the persistence of any effects observed during the previous two months of Pygeum africanum administration. The primary efficacy parameter investigated was IPSS; the other efficacy parameters were QoL, nocturnal frequency, maximum urinary flow, average urinary flow, post-voiding residual volume and prostatic volume, after one and two months of Pygeum africanum treatment and one month after stopping treatment. A total of 85 patients were evenly distributed between the three centres and completed the entire study. At inclusion their mean IPSS was 16.17, QoL was 3.60 and nocturia was 2.6 times per night. The changes in subjective scores, IPSS and QoL after the two-month treatment period were highly statistically significant with mean improvements of 40% and 31%, respectively. Nocturnal frequency was reduced by 32% and the mean reduction was again highly statistically significant. Mean maximum urinary flow, average urinary flow and urine volume were also statistically significantly improved, but the modest improvement in post-voiding volume did not reach statistical significance. The improvements, which exceeded those observed with placebo in earlier studies, were maintained after one month without treatment indicating an interesting persistence of clinically useful activity. Prostatic volume and quality of sexual life remained unchanged throughout. No treatment-related adverse effects were observed. In conclusion, under conditions of daily practice, Pygeum africanum extract induces significant improvement in IPSS and uroflowmetry parameters. These positive effects are accompanied by a very satisfactory safety profile with the overall result of a substantial improvement in QoL.     

Tamsulosin 0.4 mg once daily: tolerability in older and younger patients with lower urinary tract symptoms suggestive of benign prostatic obstruction (symptomatic BPH). The European Tamsulosin Study Group

OBJECTIVES: To compare the safety and tolerability of tamsulosin 0.4 mg once daily in younger (< 65 years) and older (> or = 65 years) patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO). METHODS: In a retrospective analysis of two European double-blind, randomized, placebo-controlled trials, safety was assessed in 574 younger or older patients treated with tamsulosin or placebo for 12 weeks. RESULTS: The incidence of adverse events, drug-related adverse events, serious adverse events and discontinuations due to adverse events was similar in older and younger tamsulosin-treated patients and was not significantly different from placebo. Although abnormal ejaculation was slightly more common in younger than older men receiving tamsulosin, the difference was not statistically significant from the placebo groups in both age groups. The incidence of adverse events possibly associated with vasodilation in tamsulosin-treated younger and older patients was 8.4 and 4.2%, respectively; these were comparable with the values for placebo-treated patients: 7.5 and 6%, respectively. Baseline systolic blood pressure was higher in older than younger patients, but there were minimal changes in blood pressure or pulse rate in tamsulosin- or placebo-treated patients in either age group. CONCLUSIONS: Tamsulosin is well tolerated and suitable for use in older and younger patients with LUTS suggestive of BPO (symptomatic BPH).     

A long follow-up on prostate specific antigen density and prostate biopsy

OBJECTIVE: To determine prostate specific antigen density (PSAD) in a risk population without evidence of prostatic cancer, and to assess the long-term usefulness of PSAD as a parameter for determining the need for a prostatic biopsy in patients with a normal digital rectal examination (DRE) and transrectal ultrasound (TRUS). METHODS: The records of 582 patients referred to the clinic between February, 1992 and February, 1994 were studied retrospectively. All these patients with lower urinary tract symptoms (LUTS) were evaluated based on the following parameters: digital rectal examination, serum PSA levels, prostate volume measured using transrectal ultrasound and PSAD. Prostatic biopsy was performed on 431 patients who had a serum PSA level greater than 4.0 ng/mL. A total of 299 patients (69.3%) had PSA levels between 4.0 and 10.0 ng/mL and represented the target population. The study had two parts, in the first one cancer was diagnosed just by one biopsy and in part II, the patients with negative biopsy in part I were followed for a two-year period and required 2 or 3 biopsies for diagnosis. Of the total of patients who had a negative prostate biopsy in part I of the study, 269 were followed for a period of two years with repeated prostate biopsies. RESULTS: Overall prostate cancer was detected in 22/299 (13.9%) patients, 6/105 (5.7%) with PSAD up to 0.15 and 16/194 (8.2%) with PSAD over 0.15 (p = 0.569). CONCLUSION: PSAD is a useful indicator in decreasing the number of negative biopsies in patients with benign prostatic hyperplasia. However, in a long-term follow-up the PSAD (cutoff level 0.15) was unable to predict which patients had a positive biopsy. According to our results, 5.6% of patients with prostate cancer will be missed using the PSAD criteria.     

Mortality due to prostatic carcinoma in northern Sweden

In a retrospective study 6890 patients with prostate cancer from the North Swedish Cancer Register were analyzed according to cancer specific survival. Prostate cancer mortality was 40% in patients with well differentiated cancers, 54% in patients with moderate differentiated prostate cancer and 72% in men with low differentiated prostate cancer. Prostate cancer mortality was 80% in men younger than 60 years, 63% in men 60-69 years old, 53% in men 70-79 years old and 49% in men older than 80 years.