Randomized Placebo Controlled Trial of Sildenafil Citrate, Cognitive Behavior Sex Therapy and Integrated Treatment in Men Diagnosed With Non Organic Erectile Dysfunction
Abstract
Introduction The integrated treatment combining phosphodiesterase-type 5 inhibitors (PDE5i) and Cognitive Behavior Sex Therapy (CBST) has been shown to yield promising results in the treatment of Non Organic Erectile Dysfunction (NOED) in young men. Aim The current study aimed to establish the efficacy of integrated treatment combining Sildenafil Citrate (SC) 50mg and CBST as a treatment of choice in young Pakistani men with NOED. Methods One hundred thirty-seven young men were recruited to participate in the study out of 164 men referred from sexual health clinics in Pakistan. They were randomized sequentially into 4 treatment groups namely SC = 35, CBST = 34, integrated treatment = 35, and placebo = 33. 7, 4, 6, and 4 men were dropped out of each treatment group respectively. The data of 116 men were analyzed. The on demand SC 50 mg, twice weekly 50 minutes sessions and home assignments, a combination of SC and 50 minutes sessions, and placebo were administered to firsst, second, third, and fourth group respectively for a period of 12 weeks. The follow-up assessment was done after 12 weeks of post-treatment for all groups. Main Outcome Measures The Urdu standardized versions of International Index of Erectile Functoning-5 (IIEF-5) and Depression Anxiety Stress Scale-21 (DASS-21) were the main outcome measures. Results The mixed repeated measures analysis of co-variance yielded significant impact of both CBST and integrated treatment groups in improving IIEF-5 scores at…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 164 participants or records.
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