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Objective: Testosterone levels play a role in cardiac and vascular pathology. In the present study we investigated the prognostic significance of this hormone for cardiovascular outcome, in a 5-year follow-up., Materials and Methods: Our cohort included 802 adult subjects, from 40 to 80 years. Patients were excluded if they had a past history of peripheral or coronary artery disease, and revascularization. A blood sample was drawn to valuate testosterone level, and we considered normal testosterone levels 300 ng/dl. FMD (flow mediated dilatation) of the brachial artery was assessed by measuring the increase of the brachial artery diameter during reactive hyperemia after transient forearm ischemia. B-mode longitudinal images of the brachial artery were obtained at the level of the antecubital fossa. The FMD was defined as the percentage change in the brachial artery diameter 60 s after releasing the ischemic cuff. Erectile dysfunction (ERD) was assessed by the International Index of Erectile Function-5 (IIEF-5) score questionnaire. We considered composite end points including the following major adverse cardiovascular events (MACEs) Results: Subjects with lower serum testosterone levels (n = 332) had higher prevalence of traditional cardiovascular risk factors, such as hypertension (p = 0.009), diabetes (p = 0.03), dyslipidemia (p < 0.0001), obesity (p = 0.002), and endothelial function score (p < 0.0001). AMI, death after AMI, major stroke and all clinical events were more frequent (p < 0.001) in patients with testosterone levels < 300 ng/dl. Further, by multiple logistic regression analysis we found that only dyslipidemia (p = 0,001), obesity (p = 0,007), testosterone < 300 ng/dl (p < 0,0001) and ED (p < 0,0001) were independent predictors of future events., Conclusions: A therapeutic intervention on testosterone may not only have a positive effect on the cardiovascular system but also an important role in preventing new cardiovascular events.

The aim of this study was to evaluate abiraterone's efficacy in Italian patients affected with metastatic prostate cancer progressing after treatment with docetaxel. We conducted a retrospective analysis of 60 patients. Prostate-specific antigen (PSA) reduction in serum was the primary endpoint for evaluating the efficacy of abiraterone in combination with prednisone treatment, whereas reduced pain, safety, progression-free survival, response rate, and overall survival (OS) were secondary endpoints. A significant correlation was noticed between PSA response and OS. Further, the Index Bravais-Pearson (r) correlation allowed us to observe a significant negative interdependence between PSA response and reduction in pain of 0.57 (95% confidence interval: -0.30 to 0.80) (P=0.005). Meanwhile, regression analysis revealed that PSA levels are predictive of OS. There was a positive correlation with OS, which showed a value of R to 0.50 with a slope of 1.44 (P=0.0021). Abiraterone is a well-tolerated and effective treatment modality for patients affected with metastatic castration-resistant prostate cancer. The drug has a better tolerability profile, gives significant pain relief, and increases the survival rate.

Objectives: Premature Ejaculation (PE), the commonest sexual dysfunction in males, is generally treated with local anesthetic and SSRI (Dapoxetine). The aim of our study was investigate Group Psychotherapy as an alternative treatment for PE and compare the efficacy of pharmacological treatment and psychotherapy, either alone or in combination, in terms of response and improved Quality of Life (QoL). From a male outpatient population screened for PE, those who received a diagnosis of PE were proposed for the study, enrolled and divided into 3 groups (A, B and C). Each group was treated with Dapoxetine, Group Psychotherapy alone and Dapoxetine and Group Psychotherapy, respectively., Materials and Methods: Out of 1237 male outpatients, 353 received a diagnosis of Premature Ejaculation. Of them, 279 were enrolled in the study and randomized into 3 groups (A, B and C). Only 157 patients were evaluable. Before and after treatments all participants completed two questionnaires to evaluate PE status and anxiety and referred their IELT., Results: GROUP A: The mean post-treatment Premature Ejaculation Diagnostic Tool (PEDT) score decreased from 12.95 to 8.26, while the mean Intra-vaginal Ejaculation Latency Time (IELT) increased from 50.77 sec to 203 sec. (p &lt; 0.05); GROUP B: Reduction in the mean PEDT from 13.44 to 5.11 and an increased IELT from 48.33 to 431.11 sec (p &lt; 0.001); GROUP C: The mean post-treatment PEDT score decreased from 12.29 to 5.57, while the mean IELT increased from 46.86 to 412.14 sec (p &lt; 0.001). All groups recorded an improvement in anxiety., Conclusions: According to our results Group Psychotherapy is an alternative method of treatment for PE. Group Psychotherapy plays a significant role in the treatment of PE, determining a better improvement of symptoms than Dapoxetine alone even if not statistically significant.

Introduction: The aim of this study was to evaluate the incidence of sexual dysfunctions in males with epilepsy, the type of epilepsy, the frequency of seizures, the type of antiepileptic drugs (AEDs), the serum hormonal profile and the presence of psychiatric comorbidity., Methods: Sixty-one patients focused on type of epilepsy, frequency of seizures, AEDs, hormonal profile and presence of mood disorders. We excluded all patients with severe neurologic and psychiatric impairment and patient who were not able to fill questionnaires. Mean age was 31.2 years (range 18-50 years); 31 patients (50.8%) had an idiopathic generalised epilepsy and 30 (49.2%) a focal epilepsy; among them, latter 18 (60%) had probably symptomatic type and 12 (40%) symptomatic type. Sexual functions were evaluated by "International Inventory of Erectile Function" questionnaire., Results: Out of 61 enrolled patients, 22 (36.7%) showed sexual dysfunctions: erectile dysfunctions in 14 (23%), orgasmic dysfunctions in (11.5%) and sexual drive dysfunctions in 12 (19.7%). Out of 61 patients, 36 were subjected to blood measurement of sexual hormones and 21 (58.3%) showed hormonal modifications., Conclusions: Sexual dysfunction are present in 36.7% of enrolled males with epilepsy; there is any association between sexual dysfunctions and various AEDs in the treatment, except for carbamazepine (CBZ); there is not any association between sexual dysfunctions and frequency of seizures; hormonal changes are associated with sexual dysfunction in males with epilepsy treated with AEDs but not with the orgasmic dysfunction; there is not any association between hormonal changes and type of AEDs, except for CBZ; depression is associated with sexual dysfunctions.

The aim of our work was to evaluate the long-term changes in symptoms (median 42 months) and to analyze data for any negative predictive factors for the application of the procedure, in patients who underwent to urethroplasty with dorsal buccal mucosa graft. During the period from 2010 to 2015 27 patients were examined. Than they underwent urethroplasty using dorsal buccal mucosa graft (graft of 4 x 2.5 cm). The evaluation of symptoms has been addressed through the application of the IPSS Quality of Life Questionnaire (International Prostatic Symptoms Score) and the evaluation of urinary flow has been carried out by a comparative analysis between the pre- and post-operative uroflowmetry. As our study has shown, data obtained by the screening tests in the post-operative follow-up indicate that there is an increase in the maximum flow of urine until 1 month after surgery. The results in the long-term follow-up are different because they show a partial reduction of the maximum flow although it is maintained around an average value of 23 ml/s being still higher than the maximum flow in the pre-operative period. According to our results it follows that there is a low failure rate of the procedure after a median of 42 months. Only in patients with urethral stenosis longer than 2 cm, a lower long term success is achieved. From what we could observe, this length of the stenosis seems to be the only negative predictive factor for long-term maintenance of a good Quality of Life in patients undergoing the procedure. The results obtained from our study confirm literature data according to which, the gold standard for 2-cm long bulbar urethral stricture whose lumen is well preserved with circumferential spongiofibrosis limited to 1-2 mm is the dorsal graft urethroplasty with buccal mucosa that in our study showed success rates higher of 80% after a median follow up of 42 months and a percentage of relapse-free patients of 82.1% ( median 3.5 years).

Background/Aims/Objectives: We have investigated the clinical and physiological effects of Transfer Capacitive Resistive Energy (TCARE) therapy on men with Peyronie's disease (PD)., Methods: Ninety-six men with PD have been randomized in a 2:1 ratio to receive 3 sessions of TCARE therapy or sham therapy. Pain, penile curvature and erectile function have been assessed before the first treatment and up to 9 months after the end of treatment, using the Visual Analogue Scale for the pain, a goniometer to measure the degree of curvature using at-home photography and an International Index of Erectile Function (IIEF-5) questionnaire., Results: A significant pain reduction at the end of the treatment in 51 (79.6%) patients (p < 0.01) of the treated group was observed. No significant improvements in the sham group (p = 0.23) have been observed. No statistical differences in the degree of curvature have been observed in both groups. No statistical improvements have been observed in the IIEF-5 questionnaire. Adverse events have not been reported., Conclusion: This is, to our knowledge, the first randomized, single-blind, sham-controlled study that shows that TCARE has a positive short-term clinical effect on pain in patients with PD. The feasibility and tolerability of this treatment produce an attractive new therapeutic option for men with PD., (© 2017 S. Karger AG, Basel.)

Purpose: The pentose phosphate pathway (PPP) has been shown to play an important role in the metabolism of cancer cells. The transketolase-like 1 gene (TKTL1) encodes an enzyme representing an essential component of this pathway. Its expression has been demonstrated to correlate with stage and outcome in various tumors. The aim of the present study was to assess expression patterns and the prognostic role of TKTL1 in muscle-invasive bladder cancer (MIBC)., Patients and Methods: The expression of TKTL1 was assessed in a tissue microarray consisting of histopathologically benign and malign tissue of 112 patients who underwent radical cystectomy due to MIBC. Cytoplasmatic and nuclear expression were assessed by immunohistochemistry and compared separately with clinicopathologic parameters and outcome., Results: Cytoplasmatic expression of TKTL1 was exclusively present in tumor tissue. In contrast, the proportion of nuclei positive for TKTL1 was higher in histopathologically benign tissue compared with malign tissue. No correlation was observed between cytoplasmatic or nuclear TKTL1 expression and tumor stage, grade or the presence of metastases. Patients with lymph node involvement showed a decreased frequency of cytoplasmatic expression compared with node-negative patients (p = 0.01). However, no further correlation was observed between the expression of TKTL1 and clinical outcome of patients., Conclusions: The present study shows that the cytoplasmatic expression of TKTL1 is specific for MIBC tissue compared with histopathologically benign urothelium. This specific expression is present in a subgroup of MIBC potentially identifying patients with activated PPP suitable for a targeted inhibition of sugar metabolism. In contrast to other malignancies, TKTL1 shows no prognostic significance in MIBC.

Purpose: To compare patient scar satisfaction after retropubic, standard laparoscopic, mini-laparoscopic (ML) and open radical prostatectomy (RP)., Methods: Patients undergoing RP for a diagnosis of localized prostate cancer at a single academic hospital between September 2012 and December 2013 were enrolled in this prospective nonrandomized study. The patients were included in three study arms: open surgery, VLP and ML. A skin stapler was used for surgical wound closure in all cases. Demographic and main surgical outcomes, including perioperative complications, were analyzed. Surgical scar satisfaction was measured using the Patient and Observer Scar Assessment Questionnaire (POSAS) and the two Body Image Questionnaire (BIQ) scales, respectively, recorded at skin clips removal and either at 6 months after surgery., Results: Overall, 32 patients were enrolled and completed the 6 month of follow-up. At clips removal, laparoscopic approaches offered better scar result than open surgery according to the POSAS. However, at 6 months, no differences were detected between VLP and open, whereas ML was still associated with a better scar outcome (p = 0.001). This finding was also confirmed by both BIQ scales, including the body image score (ML 9.8 ± 1.69, open 15.73 ± 3.47, VLP 13.27 ± 3.64; p = 0.001) and the cosmetic score (ML 16.6 ± 4.12, open 10 ± 1.9, LP 12.91 ± 3.59; p = 0.001). Small sample size and lack of randomization represent the main limitations of this study., Conclusions: ML RP offers a better cosmetic outcome when compared to both open and standard laparoscopic RP, representing a step toward minimal surgical scar. The impact of scar outcome on RP patients' quality of life remains to be determined.

Background: The role erectile dysfunction (ED) coupled with low testosterone levels as early markers of atherosclerosis is not well understood., Objectives: To analyze the relationship between serum testosterone levels with both ED and brachial artery flow-mediated vasodilation (FMD), in a primary prevention sample of men., Methods: We enrolled 802 asymptomatic, intermediate CV risk patients, according to the Framingham Risk Score, aged 40-80 years, who underwent the ultrasound examination of FMD, the evaluation of ED and the assessment of total serum testosterone levels., Results: Testosterone levels correlated both with FMD (r = 0.85; p < 0.0001) and IIEF-5 score (rs = 0.65; p < 0.0001). Multivariable logistic regression analyses revealed that lower serum testosterone levels were strongly associated (p < 0.001) with severe (OR 0.78; 95% CI: 0.62-0.86), and moderate ED (OR 0.85; 95% CI: 0.72-0.97), while impaired FMD percentages were strongly associated (p < 0.001) with severe (OR 0.68; 95% CI: 0.59-0.79), moderate (OR 0.76; 95% CI: 0.63-0.83) and mild to moderate ED (OR 0.8; 95% CI: 0.69-0.94). Mild ED resulted statistically associated with lower FMD (OR 0.94; 95% CI: 0.82 - 1.07; p = 0.03) but not with serum testosterone levels. These relations were not substantially affected by adjustments for further potential confounders including smoking status, hypertension, diabetes mellitus and body mass index., Conclusions: lower total serum testosterone levels are associated with impaired FMD and ED in this sample of intermediate CV risk men according to the Framingham Risk Score., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Introduction and Objective: Cytokines may be involved in the pathogenesis of Peyronie's disease (PD). In this case, biological drugs, acting on specific cytokines, could be adopted in the pharmacological treatment of the disease., Materials and Methods: Twenty PD patients and 8 patients affected by congenital recurvatum penis (control group) who underwent corporoplasty were enrolled in the study. Histological examination and measurement by Real Time PCR of the expression of the encoding genes for IL-2, IL-4, IL-6, IL-10, IL-13, TGF-β, TNF-α and IFN-γ were performed on the removed tunica albuginea (TA). For the normalization of data GAPDH (glucerldehyde-3fosfatehydrogenase) and GUSB (β-glucuronidase), housekeeping genes were used. The analysis of the data was performed using the comparative method of ΔCt. The results were reported with the Fold of induction (FOI) method., Results: The histological exams of TA showed only fibrous tissue without cavernous tissue. The analysis of gene expression of IL-6, IL-10, IFN-γ and TGF-β1 showed in all samples very low levels. The levels were lower in PD patients although the differences were not statistically significant. An exception was represented by TGF-β that showed a higher level in PD patients, although not statistically significant. The expression of IL-4, IL-13 and TNF-α was undetectable., Conclusions: The expressions of cytokines in TA of PD patients compared to those of the controls do not show any significant difference. A bias of our study is that the groups were not age-matched. This is a bias already present in similar experiences and due to the different pathogenesis of the diseases. Cytokines promoting inflammation resulted undetectable and do not seem to be involved in PD pathogenesis. The higher level of TGF-β, a pro-fibrotic cytokine, detected in PD could explain the presence of fibrotic tissue. Presently, there is no data suggesting a possible role of biological drugs in PD.

Unlabelled: Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Peyronie's disease (PD) is an acquired curvature of the penis attributable to progressive fibromatosis of the tunica albuginea (TA). It is frequently associated with Dupuytren's contracture and those of Ledderhose. More recently it was found that patients suffering from PD also often suffer from diabetes mellitus and gout. Cigarette smoking and the intake of large amounts of alcohol are considered risk factors for PD.The exact aetiology of the disease is unknown, however, the trauma hypothesis is shared by most authors. According to this theory, repeated sexual microtrauma in people genetically predisposed could cause PD. The inflammatory process leads to the formation of fibrosis and plaques. Plaque can lead to penile curvature and may reduce its functionality. Pain is the most common symptom of early-stage disease. In the late stages the pain disappears, but erectile dysfunction may occur. Surgical treatment is available, but this exposes the patient to a greater risk of erectile dysfunction and it is most frequently associated with a reduction in the length of the penis. The rationale for local medical therapy is to use a treatment that acts on the initial phase of the disease by reducing and stopping the processes that lead to fibrosis, thus stabilizing the disease. Systemic medical therapy is usually accompanied by high rates of recurrence. Many authors consider local drug therapy more appropriate. Local treatment consists of several types of medication, but results are often sub-optimal. Anti-inflammatory or immunoregulatory therapy, either systemic or topical, has shown some efficacy when administered early in the disease by modulating the inflammatory response and attenuating the alteration of tissue repair. Unfortunately, in most cases, patients are first seen when the plaque is chronically inflamed, stabilized and sometimes already calcified. We have tested a biological drug for intralesional administration for the first time. We chose iloprost, an analogue of prostacyclin I2, for its theoretically favourable properties. If used i.v., it has been shown to be effective in treating vascular ischaemic disease such as thromboangioitis obliterans, peripheral arterial occlusive disease, Raynaud's phenomenon and systemic sclerosis. The rationale for the therapeutic use of iloprost in the late stages of PD is based on the assumption that activation of fibrinolysis induced by the drug would be able to determine a regression of the plaque with a consequent reduction of the curvature on erection. The main purpose of this phase I study was to evaluate the safety and tolerability of this drug injected in the context of the fibrous plaque on a small number of patients before designing a large-scale randomized trial. According to the results,therapy with intralesional iloprost in Peyronie's disease seems to be safe and tolerated and is a possible alternative to surgery., Objective: To assess the safety and tolerability of intralesional injections of iloprost (an I2 prostacyclin analogue) for its ability to suppress the production of connective tissue growth factor in fibroblasts, for the treatment of Peyronie's disease (PD)., Patients and Methods: A total of 38 patients with PD were preliminarily assessed according to symptoms, the degree of penile curvature and the size and number of plaques. Each patient received weekly intralesional injections of iloprost 200 ng in 1 mL normal saline for 5 weeks. If tolerated, the single dose was increased weekly to the maximum of 400 ng (2 mL). All the patients were preliminarily evaluated using at-home photography and were re-evaluated 2 months after the end of the treatment regimen. There was no placebo control group in this phase I study., Results: Almost all patients showed mild side effects (burning or pain) during the treatment at the site of injection. All patients tolerated well a iloprost dose of 200 ng; 19 patients reached a 300 ng dose and 14 tolerated a 400 ng dose without showing side effects. A total of 29% of the patients showed an improvement in curvature., Conclusion: The results show that therapy with intralesional iloprost is a possible alternative to surgery for Peyronie's disease., (2011 BJU INTERNATIONAL.)

Purpose: To evaluate the effect of α1-adrenergic receptor antagonists (α1-ARAs) on pupil diameter and determine whether the diameter predicts intraoperative floppy-iris syndrome (IFIS)., Setting: Ophthalmology Section, Palermo University, Palermo, Italy., Design: Prospective cohort study., Methods: Male outpatients taking tamsulosin, α(1)-ARAs, or no α(1)-ARAs having phacoemulsification were recruited. Pupils were measured 1 month preoperatively, immediately preoperatively, and postoperatively under mesopic low (0.4 lux) and high (4.0 lux) illumination after pharmacologic dilation. The IFIS severity was graded., Results: Each group comprised 50 patients. Pharmacologic dilation in both α(1)-ARA groups was statistically significantly less than in the no α1-ARA group 1 month preoperatively, immediately before surgery, and postoperatively (P=.001, P<.0005, and P<.0005, respectively). The IFIS incidence differed significantly between the tamsulosin and other α(1)-ARA groups and the no α1-ARA group (P<.0005 and P=.017, respectively) and between the tamsulosin group and the other α1-ARA group (P=.027). On regression analysis, the hazard ratio for overall IFIS incidence was 3.8 in the other α(1)-ARA group (P=.012) and 10.1 in the tamsulosin group (P<.0005). Pupil size was inversely related to IFIS incidence and severity (P<.0005). A dilated pupil of 7.0 mm or smaller had 73% sensitivity and 95% specificity for predicting IFIS (P=.0001)., Conclusions: Pupil dilation was inhibited by α(1)-ARAs, in particular tamsulosin. For a pupil 7.0 mm or smaller, the risk for IFIS existed regardless of α(1)-ARAs treatment, which surgeons should take into consideration., (Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: We evaluated the prevalence and estimated the incidence and risk factors of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy., Materials and Methods: From January to June 2006 patients from 28 Italian urological centers who were between 25 and 50 years old with symptoms of chronic prostatitis/chronic pelvic pain syndrome were consecutively enrolled in this prospective epidemiological case-control study. A total of 152 subjects of similar age, race and area of origin who were investigated for infertile couples but were otherwise healthy served as controls. All subjects provided a medical history and underwent different symptom scorings, clinical evaluation and microbiological tests., Results: Of 5,540 male urological outpatients 764 with chronic prostatitis/chronic pelvic pain syndrome were enrolled, including 225 (29.4%) at the first presentation and 539 (70.6%) who underwent previous treatment. Thus, the prevalence of the syndrome was 13.8%, while the estimated incidence was 4.5%. Cigarette smoking, a high caloric diet with low fruit and vegetable consumption, constipation, meteorism, slow digestion, a sexual relationship with more than 1 partner and coitus interruptus were more likely in patients with chronic prostatitis/chronic pelvic pain syndrome than in controls (each p <0.001). The syndrome had a negative influence on sexual desire, erectile dysfunction and premature ejaculation (p <0.001). The Meares and Stamey test was positive in 13.3% of patients and in 2.9% of controls. Urethral swabs in patients with a negative Meares and Stamey test were positive for sexually transmitted pathogens in 6%., Conclusions: The prevalence and estimated incidence of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy are high. The syndrome is closely related to lifestyle, diet, smoking, gastrointestinal or anorectal disease and impaired sexual function.

Prostatitis is the most frequently diagnosed illness in men under 50, accounting for about 8% of all consultations with urologists. Estimates based on published studies suggest that the incidence of prostatitis in the population is somewhere between 4% and 11%. In 1995 the National Institutes of Health (NIH) classified prostatitis into 4 main categories: 1) acute bacterial; 2) chronic bacterial; 3) pelvic pain syndrome; 4) asymptomatic inflammatory. The aetiological agent most often involved is bacterial, particularly the category of Gram (-) bacteria, followed by Gram (+), chlamydiae and mycoplasmas; however many cases of prostatitis are caused by bacteria which are difficult to isolate or by aetiopathogenic mechanisms which are immunological, neurological, psychosomatic or anatomical in nature. An observational study was recently done on the Italian territory in order to estimate the incidence and risk factors of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The disease incidence estimation was 13.8%. Cigarette smoking, high caloric diet with low consumption of fruit and vegetables, constipation, meteorism, slow digestion, sexual relationship with more than one partner and coitus interruptus were more likely in CP/CPPS patients than in controls (p < 0.001). CP/CPPS had a negative influence on sexual desire, erectile dysfunction and premature ejaculation (p < 0.001). The Meares Stamey test was positive in 13.3% of patients and 2.9% of controls.

Objectives: To study the ablative activity of intravesical gemcitabine against superficial transitional cell carcinoma of the bladder at different doses and concentrations., Methods: A total of 27 patients were treated with intravesical gemcitabine after transurethral resection during which one to three papillary marker lesions were left unresected. Starting 14 days after transurethral resection, six instillations of gemcitabine were given at weekly intervals. Gemcitabine, diluted in 50 mL of saline solution and maintained for 2 hours, was given at the dose of 500 mg, 1000 mg, and 2000 mg in groups of 9 patients each. A complete response (CR) was defined as negative cytology, cystoscopy, and biopsy findings. Patients achieving a CR received monthly maintenance for up to 1 year and underwent cytology and cystoscopy at 3-month intervals., Results: Of the 27 patients, 1 was lost to follow-up, and of the remaining 26 patients, 6 (23%) achieved a CR. A CR was achieved in 1 patient (12.5%), 2 patients (22.2%), and 3 patients (33.3%) at a dose of 500, 1000, and 2000 mg, respectively. A partial response was obtained in 2 additional patients (22%) at a dose of 500 and 1000 mg. Bladder Tis was diagnosed in 2 patients with a CR at 3 and 8 months after treatment. The remaining 4 patients were disease free at a follow-up of up to 22 months. Systemic and local tolerability was excellent, and no treatment interruption was required., Conclusions: Our experience has shown the good tolerability and potential efficacy of intravesical gemcitabine against recurrent transitional cell carcinoma of the bladder. Gemcitabine might be proposed, if our results are confirmed by larger studies, as a second-line therapy in patients who cannot tolerate more aggressive intravesical therapy.

Objectives: To evaluate a highly selected population of patients affected by T1G3 bladder transitional cell carcinoma (TCCB) treated by transurethral resection (TUR) and adjuvant intravesical chemotherapy., Materials and Methods: Between January 1976 and April 1999, 137 patients with T1G3 TCCB were treated by TUR plus intravesical chemotherapy. Particularly, a sequential combination of mitomycin C (MMC) and epirubicin (EPI) was adopted in 91 patients (66.4%). The main exclusion criteria were concomitant or previous Tis, previous T1G3 TCCB, tumor size greater than 3 centimeters and number of tumors more than 3. TUR was repeated if a superficial tumor recurred. Patients went off study if Tis, recurrent T1G3 or invasive tumor were detected during treatment or thereafter. Adjuvant therapy, recurrence and progression were considered in multivariate analysis regarding recurrence, progression and survival respectively., Results: Observation period was up to 240 months with a minimum of 2 years in 112 patients (82%). Seventy patients (51%) recurred. The recurring tumor was again a T1G3 in 22 (16%) patients. Thirteen patients (9.5%) progressed. The 5-year progression-free survival rate was 90%. Median progression-free survival was 149 months. Twenty-two patients (16%) died, 9 (6.6%) of whom due to bladder cancer. Median overall survival was 155 months. The 3- and 5-year disease-free overall survival rates were 89% and 80% respectively. Ten cystectomies (7.3%) were performed. In conclusion, 123 patients (90%) maintained their intact bladder with a mean disease-free overall survival of 104 months. The sequential combination of MMC and EPI adjuvant therapy resulted more effective to be than single drug chemotherapy on recurrence rate (p=0.0021) but had no impact upon progression (p=0.127) and specific survival (p=0.163). Progression (p<0.001) after conservative treatment was the main prognostic factor for survival., Conclusion: A conservative approach is an appropriate therapeutic option for the initial management of selected T1G3 bladder tumors.

Purpose: To study GP-170 in superficial bladder cancer at initial diagnosis and at recurrence and to evaluate if intravesical chemoprophylaxis modifies the expression of GP-170 in tumor recurrences., Materials and Methods: GP-170 was retrospectively assessed in 160 patients affected by primary superficial transitional cell carcinoma of the bladder and followed for up to 10 years. Eighty-four patients (52.5%) recurred after transurethral resection (TUR). Adjuvant intravesical chemotherapy after TUR was adopted in 52 patients. The correlations between GP-170 and G-grade, T-category, risk of recurrence and of progression, and adoption of adjuvant intravesical chemotherapy were investigated. The correlations between variations in grade and stage at recurrence and modifications in GP-170 expression were also studied., Results: No significant correlation between GP-170 expression and G-grade and T-category was found. A significant correlation was detected between GP-170 expression and recurrence ( P=0.0383). It showed a biphasic pattern, i.e., tumors that did not express GP-170 had a higher recurrence rate, but high GP-170 levels were also associated with an increasing risk of recurrence. Intravesical chemotherapy did not induce significative variations in GP-170 expression. No correlation was found between progression and GP-170., Conclusion: GP-170 seems to be an independent prognostic factor for recurrence in superficial bladder tumors. A negative GP-170 pattern and high levels of GP-170 are associated with an increasing risk of recurrence but have no impact upon progression. In our experience, GP-170 is neither induced nor modified by intravesical chemotherapy, although it might represent a factor of chemoresistance when strongly expressed.

Introduction: The glycoprotein P-170, causing drug efflux from the cells, may represent at least one cause of resistance to most drugs used in intravesical chemotherapy of superficial bladder cancer., Materials and Methods: GP-170 was retrospectively assessed in 60 patients affected by superficial transitional cell tumours of the bladder. It was assessed by immunohistochemistry in a semiquantitative way by the intensity of staining and by the percentage of positive cells. Correlation of GP-170 expression with G-grade, T-category, multiplicity, recurrence rate and treatment was investigated. In 44 patients recurrence was analysed in relation to GP-170 basal expression and to its variations. The monoclonal antibody JSB1 (DBA) at 1:20 dilution was employed for the GP-170 assay., Results: GP-170 expression increases with grade but was lower in multiple tumours. No difference between Ta and T1 categories was detected. GP-170 immunohistochemistry from different portions of the same tumour showed a very marked variability in 35.7% of patients. Seven patients (11.6%) were totally negative for GP-170. No statistically significant correlation was found between recurrence, progression and GP-170 basal expression. Similarly no correlation emerged between grade and stage variations at recurrence and modifications in GP-170 expression. One third of the tumours recurring after chemotherapy were negative for GP-170 in spite of an increase in recurrence rate and other risk factors., Conclusion: At the present stage of our experience, we have been unable to show that GP-170 is a useful marker for monitoring chemoresistance to intravesical chemotherapy in superficial bladder cancer. Furthermore, GP-170 determination has shown several technical difficulties.