Randomized Placebo Controlled Trial of Sildenafil Citrate, Cognitive Behavior Sex Therapy and Integrated Treatment in Men Diagnosed With Non Organic Erectile Dysfunction

Ahmad Bilal; Najam Ul Hasan Abbasi

doi:10.1016/j.esxm.2021.100464

Randomized Placebo Controlled Trial of Sildenafil Citrate, Cognitive Behavior Sex Therapy and Integrated Treatment in Men Diagnosed With Non Organic Erectile Dysfunction

Sex Med. 2022 Feb;10(1):100464. doi: 10.1016/j.esxm.2021.100464. Epub 2021 Dec 16.

Authors

Ahmad Bilal¹, Najam Ul Hasan Abbasi²

Affiliations

¹ PhD Research Scholar, Department of Psychology, International Islamic University, Islamabad, Pakistan; Assistant Professor, Department of Applied Psychology, The Islamia University of Bahawalpur, Bahawalpur, Pakistan. Electronic address: ahmadbilal4@gmail.com.
² Associate Professor, Department of Educational Sciences, Mianyang Normal University, Sichuan, China; Ex Assistant Professor, Department of Psychology, International Islamic University, Islamabad, Pakistan. Electronic address: nhabbasi@gmail.com.

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 post treatment as compared to placebo. The CBST group experienced reduction in depression scores at post treatment as compared to both SC and integrated treatment. Only the integrated treatment brought reduction in anxiety scores at post treatment as compared to SC. The covariates age and NOED duration did not significantly impact the treatment outcome for all treatment groups.

Clinical implications: The efficacy of integrated treatment approach for improving symptoms of NOED and associated depression and anxiety is strong clinical implication of the study.

Strengths & limitations: The effectiveness of integrated treatment approach in the improvement of NOED symptoms and associated depression and anxiety scores is the main strength of the study. The improvement in depression scores is the added strength of CBST component of integrated treatment approach. The study should have included other PDE5i to compare their effects with the CBST or placebo groups.

Conclusion: The study concludes that the CBST and integrated treatments are treatment of choice for NOED and associated depression and anxiety in young men. Bilal A, Abbasi NH. Randomized Placebo Controlled Trial of Sildenafil Citrate, Cognitive Behavior Sex Therapy and Integrated Treatment in Men Diagnosed With Non Organic Erectile Dysfunction. Sex Med 2022;10:100464.

Keywords: Cognitive Behavior Sex Therapy; Erectile Dysfunction; Integrated Treatment; Men Health; Non Organic Erectile Dysfunction; Pakistan; Placebo; Sex Therapy; Sildenafil Citrate.