A prospective multi-center trial of Escherichia coli extract for the prophylactic treatment of patients with chronically recurrent cystitis.

We have assessed the efficacy and safety of Escherichia coli extract (ECE; Uro-Vaxom) which contains active immunostimulating fractions, in the prophylactic treatment of chronically recurrent cystitis. Forty-two patients with more than 2 episodes of cystitis in the proceeding 6 months were treated for 3 months with one capsule daily of ECE and observed for a further 6 months. The primary efficacy criterion was the number of episodes of recurrent cystitis during the 6 months after treatment compared to those during the 6 months before treatment. At the end of the 9-month trial, 34 patients (all women) were eligible for statistical analysis. Their mean age was 56.4 yr (range, 34-75 yr), and they had experienced recurrent urinary tract infections for 7.2+/-5.2 yr. The number of recurrences was significantly lower during the 6-month follow-up period than during the 6 months preceding the trial (0.35 vs. 4.26, P<0.001). During the follow-up, 28 (82.4%) patients had no recurrences and 4 (11.8%) had 1 each. In patients who relapsed, ECE alleviated cystitis symptoms, including painful voiding, frequency and urgency. There were no serious adverse events related to the study drug. Our study demonstrates the efficacy and safety of ECE in the prophylactic treatment of chronically recurrent cystitis.

Usefulness of a malleable penile prosthesis in patients with a spinal cord injury.

OBJECTIVES: The usefulness of a malleable penile prosthesis was evaluated in patients with spinal cord injury (SCI) by investigating the complications and the patients' satisfaction. METHODS: A total of 48 patients with a SCI, who underwent malleable penile prosthesis (AMS 600) insertion from 1990 to 2004 were evaluated by reviewing the patients' medical records and interviewing them via questionnaires. The mean patients age was 58.9 years, and the mean follow-up period was 11.7 years. In 23 patients, penile prosthesis implantation was carried out to improve urinary management and to treat erectile dysfunction (ED). RESULTS: Complications occurred in eight patients (16.7%). Wound infections in four (8.3%). Two patients were treated with conservative management, and two were managed through prostheses removal. Other complications were erosion in two patients (4.2%), uncontrolled penile pain owing to excessive prosthesis length in one patient (2.1%), and supersonic transporter (SST) deformity in one patient (2.1%). The overall patient satisfaction rate was 79.2%. The dissatisfaction was mainly due to the complications that resulted in the removal of the prosthesis, or partner's unnatural sensation. All of the prostheses that were implanted in the patients for the improvement of their urinary management gave them the benefit of convenient urinary management, except for two patients, whose prostheses were removed. CONCLUSIONS: The insertion of malleable penile prostheses in patients with SCI is associated with low complication rates and good patient satisfaction. It is therefore still an attractive option.

An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra (sildenafil citrate) in Korean men with erectile dysfunction and arterial hypertension who are taking antihypertensive agents.

INTRODUCTION: Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure. AIM: We evaluated the efficacy and safety of sildenafil citrate in men with ED taking antihypertensive agents. METHODS: A total of 198 male subjects, aged 20 years and older were enrolled. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose trial with a 2-week screening period and an 8-week treatment phase. MAIN OUTCOME MEASURES: Subjects were asked to complete Event Log Worksheets, as well as the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Questions (GEAQ) questionnaires during the study period. RESULTS: The average age among the 167 subjects who completed the study was 55.8 (31.7 to 77.1). The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline to 3.7 and 3.4 at week 4 and 3.8 and 3.4 at week 8, respectively. There were 86.3% of the patients reported improved erectile function at week 8; 88.3% of the patients reported improved ability to achieve sexual intercourse at week 8. There were no significant differences observed in the responses to questions 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. The adverse events were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), dyspnea (2.2%), and nausea (1.7%). CONCLUSIONS: Sildenafil citrate is an effective treatment for ED; it is safe and well tolerated by patients with ED taking multiple antihypertensive agents for arterial hypertension.

Histological diagnosis of prostate cancer in Korean men aged 70-79 years.

BACKGROUND: The objective of this study was to evaluate the value of the prostate-specific antigen (PSA) in the diagnosis of prostate cancer in elderly Korean men, aged 70-79 years. METHODS: Patients with an abnormal digital rectal examination (DRE) and/or a serum PSA level greater than 2.0 ng/ml underwent a biopsy. A total of 344 men (median age 73 years) constituted the study cohort. RESULTS: Of 344 men, 163 (47.4%) were diagnosed with prostate cancer upon initial biopsy. The positive predictive value (PPV) for cancer was 48.4% for a PSA cutoff of 4 ng/ml, 65.3% for a cutoff of 10 ng/ml, and 87.0% for a cutoff of 20 ng/ml. When combined with an abnormal DRE, the predictive values for these PSA cutoffs increased to 79.3, 87.3 and 100%, respectively. When 10 ng/ml was chosen as a PSA cutoff level, about 50% of patients were found to have a Gleason score of 7 or higher. When 4 ng/ml was chosen as a PSA cutoff level, more than 50% of patients with an abnormal DRE were found to have a Gleason score of 7 or higher. CONCLUSIONS: In elderly men, more than 50% of patients are found to have cancers with a Gleason score of 7 or higher when their PSA level is greater than 10 ng/ml. This threshold may be lowered to 4 ng/ml in the presence of an abnormal DRE. Our findings provide a rationale for recommending a prostate biopsy in elderly patients with an abnormal DRE and/or an elevated serum PSA level. However, at present, it is not clear whether elderly men have better outcomes when they undergo cancer screening.

Accuracy of a high prostate-specific antigen level for prostate cancer diagnosis upon initial biopsy in Korean men.

PURPOSE: This study aimed to evaluate the cancer detection rate in a Korean population with prostate-specific antigen (PSA) levels greater than or equal to 20.0 ng/mL. MATERIALS AND METHODS: A total of 174 men 50 to 79 years old (median 69) included in the study. The median prostate volume of the patients was 44.8 mL (range 14.1 to 210.0) and their serum PSA ranged from 20.0 to 9725.0 ng/mL (median 44.8). RESULTS: Of 174 men 141 (81.0%) were diagnosed with prostate cancer on initial biopsy. In the total number of patients, the positive predictive value (PPV) was 62.9% for PSA 20 to 29.9, 72.7% for PSA 30 to 39.9 and 100% for PSA 40 to 49.9 ng/mL. In patients with an abnormal digital rectal examination (DRE), the values for these PSA ranges increased to 89.5%, 91.7% and 100%, respectively. The PPV was 81.0% for PSA cutoff of 20, 89.2% for a cutoff of 30, 95.4% for a cutoff of 40, and 94.7% for a cutoff of 50 ng/mL. In conjunction with an abnormal DRE, the values for these PSA cutoffs increased to 95.9%, 98.1%, 100%, and 100%, respectively. CONCLUSION: Our data suggest the ability to predict the presence of prostate cancer reliably on initial biopsy when PSA threshold is greater than or equal to 50 ng/mL. This PSA threshold may be lowered to 40 ng/mL in the presence of an abnormal DRE. In Korean men with high PSA, the detection rate of prostate cancer on biopsy appears to be comparable to that for American men.

Prostate biopsy in subjects with abnormal transrectal ultrasonography but normal digital examination findings and prostate-specific antigen levels.

AIM: The aim of the present study was to evaluate the value of transrectal ultrasonography (TRUS) for prostate cancer diagnosis in men with no other indication for biopsy, such as an abnormal digital rectal examination or abnormally high prostate-specific antigen (PSA) levels. MATERIALS AND METHODS: The study cohort contained a total of 104 men aged 41-78 years (median 62.5 years) who had suspicious findings on TRUS. The median prostate volume of the patients was 33.0 ml (range 15.0-90.9) and the serum PSA ranged from 0.2 to 4.0 ng/ml (median 2.5 ng/ml). RESULTS: Of 104 men, 12 (11.5%) were diagnosed with prostate cancer on initial biopsy. The positive predictive value (PPV) was 3.7% for PSA 0.1-1.0 ng/ml, 4.8% for PSA 1.1-2.0 ng/ml, 16.7% for PSA 2.1-3.0 ng/ml and 18.4% for PSA 3.1-4.0 ng/ml. The PPV for cancer with Gleason score 7 or higher was 0.0%, 0.0%, 16.7% and 7.9%, respectively. No statistically significant differences in patient characteristics and biopsy results were found between patients who received only systemic biopsy and those who received systemic plus lesion-directed biopsies. CONCLUSION: The results of this study do not provide a rationale to recommend the additional use of lesion-directed biopsy in patients with suspicious lesions at TRUS but with no other indication for biopsy. Furthermore, our data raise the question of whether serum PSA levels lower than 4.0 ng/ml should be considered normal in Asian men.

Significance of suspicious lesions at transrectal ultrasonography in men with serum prostate-specific antigen levels of < 20 ng/ml.

AIMS AND BACKGROUND: The objective of the study was to evaluate the significance of suspicious lesions at transrectal ultrasonography for prostate cancer diagnosis. PATIENTS AND METHODS: A total of 1,009 men with a mean age of 65.0 +/- 7.7 years (range, 40.0-79.0) constituted the study cohort and 265 (26.3%) were diagnosed with prostate cancer on initial biopsy. RESULTS: The cancer detection rate was higher in patients with suspicious lesions (33.2%) than in those with no suspicious lesion (21.5%) (P < 0.001). Pathologic findings of the needle biopsy samples also showed more aggressive characteristics in men with suspicious lesions (P < 0.05). Of 413 men with suspicious lesions, additional lesion-directed biopsies were performed in 133 patients. The positive predictive value of additional lesion-directed biopsy was 18.0%. Of patients who had positive cores on lesion-directed biopsies, all were also found to have positive cores on random biopsies, and no patient had positive cores only on lesion-directed biopsies. The Gleason score was not changed by the findings of lesion-directed biopsies in these patients. CONCLUSIONS: Our findings do not provide a rationale to recommend the addition of lesion-directed biopsy in patients with suspicious lesions at transrectal ultrasonography. However, men with suspicious lesions at transrectal ultrasonography had a higher risk of being diagnosed with prostate cancer.

Optimal site and number of biopsy cores according to prostate volume prostate cancer detection in Korea.

OBJECTIVES: To compare different biopsy schemes for detecting prostate cancer in Korean men. METHODS: A total of 516 men, 40 to 79 years old (mean 64.1 +/- 7.8), constituted the study cohort. The patients were divided to quartiles according to prostate volume: 10 to 30, 30.1 to 40, 40.1 to 55, and 55.1 to 162 cm3. RESULTS: The cancer detection rates decreased as the prostate volume increased in the quartiles used (P = 0.001). The group-specific cancer detection rate was 20.0% to 23.8%, 22.1% to 25.6%, 23.6% to 26.6%, and 27.7% in the 6, 8, 10, and 12-core groups, respectively. In all patients undergoing sextant biopsy, laterally placed cores, including the apex, lateral mid-gland, and lateral base, seemed as optimal as the six-core biopsy scheme. The unique cancer detection rates of each biopsy region were low in all patients groups and were not significantly different according to prostate volume quartile. Of the patients with suspicious lesions on transrectal ultrasonography, no cancer was present only in the lesion-directed biopsies, even if sextant biopsy technique was used. CONCLUSIONS: Our data have shown that lower core schemes can be used with results almost similar to those using the 12-core protocol in this population. A laterally placed, six-core technique is an appropriate biopsy scheme in patients with a prostate volume of less than 40 cm3. Transrectal ultrasound-directed biopsies can be omitted even when using six-core biopsy protocols because the yield of these biopsies was low. Prebiopsy transrectal ultrasonography is unnecessary because the prostate volume estimation can be done at the same time as the biopsy.

Detection of prostate cancer at low and intermediate serum prostate-specific antigen levels in a country with a low incidence of prostate cancer.

BACKGROUND: The objective of this study was to evaluate the cancer detection rate and the pathologic findings of biopsy in men at low and intermediate prostate-specific antigen (PSA) levels in an Asian population. METHODS: Patients between 40 and 79 years were entered into a study and 755 patients with serum PSA level of 2.0-10.0 ng/ml underwent trus-guided systematic biopsy. Patients were divided to low (PSA 2.0-4.0 ng/ml, n = 144) and intermediate (PSA 4.1-10.0 ng/ml, n = 611) PSA groups. RESULTS: Patients in the low PSA group had significantly smaller prostates (P = 0.003) and lower PSA density (P < 0.001). The rate of cancer detection was 16.7% (24 of 144) in the low PSA group and 23.7% (145 of 611) in the intermediate PSA group (P = 0.067). In men with normal digital rectal examination (DRE), prostate cancer was diagnosed in 14 (13.3%) of the 105 men in the low PSA group and 99 (19.5%) of the 508 men in the intermediate PSA group (P = 0.139). In all patients and patients with normal DRE, no statistically significant differences were found in the pathologic findings of biopsy between the two groups. CONCLUSIONS: Our findings provide a rationale to recommend prostate biopsy at lower PSA threshold in this population. At present, however, it is not clear that men who are treated when their cancers are detected at lower PSA levels have better outcomes than those who are treated when the PSA is higher than 4.0 ng/ml.

Complications of the upper urinary tract in patients with spinal cord injury: a long-term follow-up study.

The aim of this study was to establish hazard ratios for the risk of complications of the upper urinary tract in relation to bladder management methods in patients with spinal cord injury. A total of 179 male patients were eligible for this investigation which was followed-up on a yearly basis until 2003. The average age at which the lesion occurred was 25.2 years (range 18-57). The average duration of follow-up since SCI was 29.3 years (range 10-53). During follow-up, the incidence of vesicoureteral reflux (VUR) was 15.1%. A total of 61 (34.1%) and 44 (24.6%) patients were diagnosed with pyelonephritis and renal stones, respectively. There were no significant differences in these complications among groups. Upper tract deterioration (UTD) was observed in 58 patients (32.4%). The incidence of UTD in the urethral catheter group (51.7%) was higher than that in other groups (P=0.008). Using multivariate analysis, patients with VUR were shown to have a higher risk of pyelonephritis (odds ratio 2.78; 95% confidence interval 1.16-6.68), and UTD (odds ratio 22.10; 95% confidence interval 6.92-70.56). We also found that UTD was more common for patients with an indwelling urethral catheter than for patients using other methods. For other variables, no positive association was observed. In cases which cannot undergo intermittent catheterization, or when the bladder cannot empty spontaneously, a suprapubic catheter is better than a urethral catheter for reducing UTD in this population. These findings suggest that even at a late stage post injury, bladder management methods are still important.