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Randomized Controlled Trial
. 2007 Sep;4(5):1404-13.
doi: 10.1111/j.1743-6109.2007.00549.x. Epub 2007 Jul 18.

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

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Randomized Controlled Trial

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

Gerald Brock et al. J Sex Med. .

Abstract

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 1 (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 naïve. 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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