Can an Educational Program Optimize PDE5i Therapy? A Study of Canadian Primary Care Practices

Division of Urology, University of Western Ontario, London, Ontario, Canada
Journal of Sexual Medicine (Impact Factor: 3.15). 07/2007; 4(5):1404 - 1413. DOI: 10.1111/j.1743-6109.2007.00549.x


Introduction. The importance of patient instructions, designed to optimize therapy with phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction (ED), has recently been demonstrated. Aim. To evaluate the impact of an educational program for new sildenafil users against usual ED management in Canadian primary care practices. Methods. This multicenter, 6-month cluster randomized prospective study was conducted across Canada in general practitioners' offices where sites were randomized to receive a treatment optimization program (TOP) tool at visit I (TOP sites) or not to receive the TOP tool (non-TOP sites) while continuing with usual practice. Study participants were men seeking medical attention for ED and who were sildenafil naive. The TOP tool consisted of a tear-off sheet, a brochure, and a video. Study drug was not provided to the patients. Sildenafil samples and prescriptions were dispensed as per usual care practices. Main Outcome Measures. The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used to determine treatment satisfaction at visit 2 (month 3) and visit 3 (month 6). Patient and physician satisfaction with the TOP tool was assessed using self-reported questionnaires. Results. The intent-to-treat (ITT) population consisted of 2,573 patients from 231 primary care sites. At visits 2 and 3, treatment satisfaction with sildenafil was high with almost 9 patients out of 10 satisfied with treatment. No significant statistical differences were observed in the EDITS scores between the TOP and the non-TOP groups at visits 2 and 3. More than 80% of the participants were satisfied or very satisfied with the video and the brochure. More than 8 out of 10 participating physicians (84%) would use the TOP tool in their current practice if available. Conclusions. TOP is a valuable and time-efficient ED management tool providing benefits to newly diagnosed ED patients and to their physicians.

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    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. DOI:10.1111/j.1743-6109.2007.00555.x · 3.15 Impact Factor
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    ABSTRACT: There are three phosphodiesterase type 5 (PDE5) inhibitors marketed, sildenafil, Vardenafil, and tadalafil for oral treatment of erectile dysfunction (ED). Although the treatment is simple and mostly effective, around 50% has ceased to use the medication within 2 years. One recently described way to improve the compliance is to let the patient try all the three PDE5 inhibitors and to prescribe the drug(s) he and his partner desires. To study long-term compliance among patients who were treated according to this "three-drug regime." Compliance and reasons for discontinuation after >2 years. The men who, during 2003, were enrolled in a treatment regime, where they had the opportunity to test all the three drugs and to chose the one(s) they preferred, were interviewed in 2006 by telephone concerning their ongoing ED treatment and the reason for discontinuation. Of the 138 men, mean age 60 years (36-79 years), who had been enrolled and successfully treated with the three-drug regime, 127 (92%) could be reached. The mean follow-up time was 27 months (23-34 months). Of the 127 men, as many as 109 (86%) were still using PDE5 inhibitors. A few (8%) used more than two tablets per week. The majority (44%) used one to two tablets per week or one to two per month (43%), the others (5%) less often. The causes for discontinuation were varying. The most common reason (N = 7) was return of a satisfactory non-assisted erection. Seventy-five percent of the men used only one drug; the others switched between a short- and long-acting drug depending on the situation. It was not uncommon (25%) that the preference had changed during the 3 years of PDE5 inhibitor use. To let patients with ED test the three available PDE5 inhibitors results in an unusually high compliance even under an extended period of time (>2 years).
    Journal of Sexual Medicine 02/2008; 5(2):469-75. DOI:10.1111/j.1743-6109.2007.00688.x · 3.15 Impact Factor
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    ABSTRACT: Neither men with erectile dysfunction (ED) nor their physicians are willing to discuss sexual problem sufficiently. Written information material could facilitate a dialogue and encourage men to seek treatment. The central task of this article was to determine the effectiveness and acceptance of patient information material for sexual dysfunction. Through an information campaign, men received informational material. Eight thousand men also received a first survey, which asked about the intention to seek treatment and to discuss the sexual problem with a physician or partner. A second follow-up questionnaire, 3-6 months after the first one, asked for the implementation of these intentions. Descriptive and regression-based analyses were applied. Help-seeking behavior, subjective assessment of change in disease severity and partnership quality, satisfaction. Four hundred forty-three men participated in both surveys. Nearly 90% of them became active after reading the information material. More than half talked with their partner (57.8%) and a physician (65%), and one-third sought treatment (31.8%). Especially discussing the problem with the partner and receiving treatment improved erectile functioning and led to an increase in the quality of partnership (P </= 0.05). The initial intention to become active was a good predictor for completing an action. The main reasons for not becoming active were inhibitions to talk about ED (46.8%) and fear of a medical examination (27.7%). Overall, the results demonstrate that written information material is a useful resource for men with ED, because it evokes a high help-seeking behavior. It was perceived both to improve the sexual problem as well as to increase the quality of partnership. Providing such material in the medical practice may be an appropriate way to overcome inhibitions and to initiate dialogue with affected men. However, the results must be interpreted with caution because of possible motivationally driven self-selection bias.
    Journal of Sexual Medicine 03/2008; 5(2):436-47. DOI:10.1111/j.1743-6109.2007.00673.x · 3.15 Impact Factor
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