Peter Pommerville

Levofloxacin for chronic prostatitis/chronic pelvic pain syndrome in men: a randomized placebo-controlled multicenter trial.

OBJECTIVES To perform a Canadian multicenter randomized placebo-controlled trial to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy compared with placebo in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Uncontrolled studies have supported the use of antibiotics in CP/CPPS. METHODS Men with a National Institutes of Health (NIH) diagnosis of CP/CPPS (specifically, no infection localized to the prostate) were randomized to levofloxacin (500 mg/day) or placebo for 6 weeks in 11 Canadian centers. Patients were assessed at baseline and at 3, 6, and 12 weeks with the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and global patient assessments (subjective global assessment and patient assessment questionnaire). RESULTS Eighty men (average age 56.0 years, range 36 to 78; duration of symptoms 6.5 years, range 0.6 to 32) were randomized to receive levofloxacin (n = 45) or placebo (n = 35). All were evaluated in an intent-to-treat analysis. Both groups experienced progressive improvement in symptoms as measured by the NIH-CPSI. However, the difference in response was not statistically or clinically significant at end of treatment (6 weeks) or at the end of the follow-up visits (12 weeks). No patients withdrew because of adverse events. One patient withdrew before the 6-week assessment. Adverse events (all mild) were reported in 20% of the levofloxacin group and 17% of the placebo group. CONCLUSIONS This pilot placebo-controlled study showed that 6 weeks of levofloxacin therapy in men diagnosed with CP/CPPS resulted in symptom improvement that was not significantly different from that with placebo at end of treatment or follow-up. The clinical ramifications of these findings need to be addressed.

Testosterone deficiency syndrome and cardiovascular health: An assessment of beliefs, knowledge and practice of general practitioners and cardiologists in Victoria, BC

INTRODUCTION Testosterone deficiency syndrome (TDS) has been shown to be an independent cardiovascular risk factor and a predisposing factor for metabolic syndrome. As general practitioners and cardiologists primarily care for these patients, we sought to assess their knowledge, beliefs and practice patterns with respect to TDS and cardiac health. METHODS We distributed a questionnaire to all 20 cardiologists and a cohort of 128 family practitioners in Victoria, British Columbia. Of the 13 questions, 10 assessed knowledge and beliefs on TDS and 3 assessed current practice patterns. RESULTS Most respondents believed that TDS is a medical condition (66.7%) and could negatively affect body composition (62%), but a similar majority was unsure whether it was a cardiac risk factor (66.7%). While most believed that testosterone replacement therapy (TRT) could improve exercise tolerance (62%), most were unsure if it was beneficial in cardiac patients. Cardiologists were significantly less likely to believe that TRT was beneficial in preventing recurrent myocardial infarction and improving myocardial perfusion (p = 0.0133, 0.00186, respectively). The vast majority (88%) did not screen cardiac patients for TDS. If a patient was identified as having TDS, only10% of those surveyed would refer these patients to a urologist. CONCLUSION Despite its prevalence in cardiac patients, TDS is not well-understood by general practitioners and cardiologists; they lack knowledge on its deleterious cardiovascular effects. In their role as mens health advocates, urologists should educate our colleagues regarding the correlation between TDS and cardiovascular mortality and risk factors. Limitations of this study include small sample size and restricted geographic scope.

The Effect of Physician and Patient Education When Combined with Vardenafil Treatment in Canadian Males with Erectile Dysfunction: An Open-Label, Factorial-Designed, Cluster-Randomized Clinical Trial

INTRODUCTION Studies evaluating the effect of education on treatment success with phosphodiesterase type 5 (PDE5) inhibitor therapy in men with erectile dysfunction (ED) are limited. Additional education of the primary care physician (PCP) and the patient are thought to optimize the treatment of ED. AIM To assess the impact of education of the PCP or of the patient in the treatment of ED with vardenafil relative to usual care. METHODS In this 12-week, open-label, multicenter, factorial-designed, cluster-randomized Canadian study, 1,029 patients with ED were enrolled into four different education groups: usual care, patient education, PCP education, and both PCP and patient education. All groups started on vardenafil 10 mg, with the option to titrate at weeks 4 and 8. MAIN OUTCOME MEASURES The primary efficacy measure was the difference at week 4 last observation carried forward (LOCF) in the overall improvement in erectile function (EF) as measured by the Global Assessment Question (GAQ), while on background vardenafil, between those receiving education vs. those who did not. Other secondary assessments included responses to diary questions regarding penetration (sexual encounter profile, SEP2) and erection maintenance (SEP3), and to questionnaires regarding treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS]). RESULTS A total of 956 patients were included in the intent-to-treat population. Mean baseline International Index of Erectile Function-EF domain score was 13. GAQ response rates at week 4 LOCF were high (>80%) for all groups, regardless of the education given. Mean per patient SEP2 and SEP3 rates at week 12 LOCF were 86-89% and 79-83%, respectively. In an exploratory analysis, a positive relationship between GAQ responses and EDITS scores was observed (P < or = 0.0007). Vardenafil was generally well tolerated. CONCLUSIONS In men with moderate ED, vardenafil led to high success rates and satisfaction regardless of the education given. The benefits of education for PCP and patients in Canada were possibly masked by a ceiling effect in this study population.

Isolated Tuberculous Epididymitis: A Rare Complication after Intravesical Bacillus Calmette-Guerin Therapy

Intravesical instillation of Bacillus Calmette-Guerin (BCG) is the most commonly used immunotherapeutic adjuvant therapy for superficial bladder carcinoma. BCG is a live attenuated vaccine of Mycobacterium bovus which has been shown to decrease tumor recurrence rate, delay tumor progression, and improve overall survival. Intravesical BCG is well tolerated, with a complication rate under 5%. A literature review revealed tuberculous epididymitis to be a rare adverse event following intravesical BCG therapy. We report the case of an 82-year-old male undergoing BCG therapy for superficial transitional cell carcinoma of the bladder who presented with a painless right testicular mass. The patient had no previous history of tuberculosis. He successfully underwent a right orchiectomy and histopathology confirmed M. bovis as the etiological agent.