[Show abstract][Hide abstract] ABSTRACT: Benign prostatic hyperplasia (BPH), and its clinical manifestation as lower urinary tract symptoms (LUTS), is a major health concern for aging men. There have been significant advances in the diagnosis and treatment of BPH in recent years. There has been a renewed interest in medical therapies and less invasive surgical techniques. As a consequence, the treatment needs of men with mild to moderate LUTS without evidence of prostate cancer can now be accomplished in a primary care setting. There are differences in the way urologists and primary care physicians approach the evaluation and management of LUTS due to BPH, which is not reflected in Canadian Urological Association (CUA) and American Urological Association (AUA) guidelines. A "shared care" approach involving urologists and primary care physicians represents a reasonable and viable model for the care of men suffering from LUTS. The essence of the model centres around educating and communicating effectively with the patient on BPH. This article provides primary care physicians with an overview of the diagnostic and management strategies outlined in recent CUA and AUA guidelines so that they may be better positioned to effectively deal with this patient population. It is now apparent that we must move away from the urologist as the first-line physician, and allow primary care physicians to accept a new role in the diagnosis and management of BPH.
Canadian Urological Association journal = Journal de l'Association des urologues du Canada 07/2009; 3(3 Suppl 2):S92-S100. · 1.66 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
To assess the impact of education of the PCP or of the patient in the treatment of ED with vardenafil relative to usual care.
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.
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]).
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.
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.
Journal of Sexual Medicine 04/2008; 5(3):705-15. · 3.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: While the efficacy of sildenafil for the management of erectile dysfunction (ED) has been demonstrated in randomized clinical trials, few data exist on its effectiveness in a real-life setting.
The objective of this study was to examine the treatment satisfaction and effectiveness with sildenafil in a real-life setting in Canada.
A multicenter, prospective study, using an educational program aimed at optimizing sildenafil treatment, was conducted at 231 primary care sites across Canada. Patients who received their first prescription of sildenafil for ED within the usual practice of medicine were invited to participate in the study. Data were collected through patient self-administered questionnaires.
The Sexual Health Inventory for Men (SHIM) questionnaire was used to determine the erectile function at baseline, month 3 and month 6. Treatment satisfaction at months 3 and 6 was assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire.
The intent-to-treat population consisted of 2,573 patients. The mean age was 55 years (18 to 92 years). At baseline, the mean SHIM score was 11.9 with 21.7% of men having severe ED, 22.9% moderate ED, 36.5% mild-to-moderate ED, and 16.9% mild ED. At month 3, the mean SHIM score improved significantly to 18.0 (P < 0.0001) and 33.3% of patients had a SHIM score above 21 (no ED). At 6 months, the mean SHIM score was 18.7. At both months 3 and 6, approximately 89% of patients were satisfied with their treatment (i.e., EDITS score >or= 50), suggesting no attenuation of the satisfaction over the 6 months of use.
The effectiveness of sildenafil in the management of ED was demonstrated in a large cohort of men treated in a primary care setting in this Canadian real-life study. Persistence with therapy and lack of attenuation over time among the vast majority of men was shown.
Journal of Sexual Medicine 10/2007; 4(5):1414-21. · 3.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This article presents the responsiveness results of the Erectile Function Visual Analog Scale (EF-VAS) and reports, for the first time, utilities associated with erectile dysfunction (ED), as calculated by a disease-specific utility assessment. The EF-VAS is a new quality of life (QoL) instrument specific to ED that combines the strengths of the disease-specific approach to measuring QoL (greater disease relevance and responsiveness, with relevance to clinicians and patients) with those of preference-based assessments (generalizability and relevance to decision makers). The EF-VAS has demonstrated feasibility, reliability, and validity as reported in a recent publication.
Standard instrument development methodology was utilized and the finalized content was integrated into a preference based scoring instrument comprised of two visual analogue scales (VAS). The EF-VAS was implemented in a clinical trial and data from the trial was subjected to validation analysis. Three methods were used to evaluate the responsiveness of the EF-VAS: Spearman correlations, effect size and standardized response means. VAS scores were converted to von Neumann-Morgenstern (vNM) utilities through a conversion curve.
The EF-VAS was established to be responsive to changes in disease state within and between patients with ED. The EF-VAS allowed the calculation of vNM utility values and a significant increase in utility was observed in the sildenafil group compared to placebo at study end.
The EF-VAS represents an important advance in the understanding of the impact of ED on patients' QoL and in providing a mechanism to allow the quantification of the health status that patients associate with ED. Based on its responsiveness, the EF-VAS will provide an important clinical tool to assess and contribute to the understanding of the impact of treatment for ED. The EF-VAS represents a major advance in the science of health-related quality of life (HRQol) assessment, as it is the first validated ED-specific utility assessment reported in the literature.
The Canadian Journal of Urology 05/2006; 13(2):3016-25; discussion 3026. · 0.74 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Erectile dysfunction (ED) is a complex condition, which is variously influenced by physical, emotional, societal, and relationship factors. ED has serious implications for the quality of life (QoL) enjoyed by an affected male and his partner. It is very important, therefore, to understand the impact of ED on the QoL of those affected by it. Our objective was to determine if the eight-question Patient Reported Erectile Function Assessment (PREFA) could act as an independent, comprehensive disease-specific instrument in the assessment of QoL as it is impacted by ED.
During the development and validation of the Erectile Function-Visual Analog Scale (EF-VAS) (14), a new ED-specific preference-based instrument, a series of questions were included at the beginning of the assessment that would act as a way to encourage respondents to focus on their own experience with ED. Upon analysis of the EF-VAS data, it became apparent that the eight-question "warm up" section might act as a stand-alone assessment. Accordingly, the eight questions were named PREFA, and a validation analysis was undertaken to determine their consistency, feasibility, reliability, validity, and responsiveness.
The PREFA questionnaire was found to be feasible and simple to complete, reliable, and valid, with excellent responsiveness. Overall, the PREFA has demonstrated that it can perform as a stand alone, validated assessment of the impact of ED on QoL, assessing areas of QoL not previously captured in existing instruments.
The PREFA is suitable for use in clinical and research settings as a disease-specific QoL assessment tool.
International Journal of Technology Assessment in Health Care 02/2006; 22(3):372-8. · 1.55 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A novel slow release formulation of alfuzosin should improve compliance by reducing dosing to one 10 mg tablet per day. The current study examined efficacy, at 9 days and 3 months, and safety of this formulation of alfuzosin in BPH patients.
ALF-X was a 3-month, non-comparative, observational study of 353 BPH patients from 39 Canadian Urology centres.
At baseline (BL), mean age was 63.1+/-9.01 years, 92.6% of patients were Caucasian, 3.4% had a history of acute urinary retention, mean duration of the micturition disorder was 48.6+/-54.15 months, and mean PSA was 3.3+/-6.65 ng/mL. Mean total International Prostate Symptom Score (I-PSS) decreased from 17.5 at BL to 10.4 at M3--an improvement of 7.1+/-6.82 points (40.6%, p < 0.001), mostly occurring (27.0%, p < 0.001)) during the first 9 days. Mean Quality of Life Assessment Index improved by 0.7+/-1.39 points between BL and D9 (17.5%, p < 0.001), and by 1.5+/-1.52 points between BL and M3 (37.5%, p < 0.001). The proportion of 'mild' I-PSS patients increased from 11.8% (BL) to 29.7% (D9) to 39.0% (M3); those with 'severe' I-PSS decreased from 37.8% (BL) to 14.5% (D9) to 9.4% (M3). Of 144 patients with nocturia (>2 nightly voidings) at D1, 51.4% improved to < or = 2 nightly voidings at D9, and 60.4% at M3. Adverse events related to alfuzosin occurred in 7.8% of patients; 2.0% experienced serious adverse events. There were no vasodilatory events related to alfuzosin or deaths.
In routine clinical practice, slow-release alfuzosin is associated with a significant improvement in LUTS, and frequency of nocturia, and an excellent safety profile.
The Canadian Journal of Urology 08/2005; 12(4):2745-54. · 0.74 Impact Factor