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| Efficacy of tadalafil on improvement of men with erectile dysfunction caused by COVID-19: A randomized placebo-controlled trial |
Iman Shamohammadia,*( ),Seyedmohammad Kazemeynib,Mohammadali Sadighib,Tara Hasanzadeha,Alireza Dizavib
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aDepartment of Urology, Nemazee Hospital, Shiraz University of Medical Science, Shiraz, Iran
bDepartment of Urology, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran |
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Abstract Objective: According to the high prevalence of COVID-19 and the subsequent risk of men's sexual health, we decided to investigate the efficacy of tadalafil on improvement of men with erectile dysfunction caused by COVID-19. Methods: In this study, 70 outpatients who were recovered from COVID-19 without acute respiratory distress syndrome with negative polymerase chain reaction test and a complaint of erectile dysfunction were divided into two groups: 35 patients who received tadalafil 5 mg daily and 35 who received placebo. For each patient, basic assessment of sexual function was performed using the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire. Then, treatment was started from 2 months after complete recovery of COVID-19 with negative polymerase chain reaction test for 3 months. At the end of the treatments, the patients were re-evaluated for sexual function using the complete version of IIEF questionnaire. Finally, the results before and after treatment in the intervention group were compared with those of the control group. Results: Treatment with both tadalafil and placebo improved the patients' sexual function criteria compared to the baseline. However, this improvement was significantly higher in the intervention group with tadalafil than the control group with placebo (p<0.05). Conclusion: Daily administration of tadalafil 5 mg seems to be effective and safe for improvement of erectile dysfunction caused by COVID-19.
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Received: 21 August 2021
Available online: 20 January 2024
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Corresponding Authors:
*E-mail address: imanshamohammadi@yahoo.com (I. Shamohammadi).
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The study flow chart according to PRISMA statement. COVID-19, coronavirus disease 2019; ARDS, acute respiratory distress syndrome; BMI, body mass index; DM, diabetes mellitus; ED, erectile dysfunction; HTN, hypertension; HLP, hyperlipidemia; PCR, polymerase chain reaction; F/U, follow-up.
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| Characteristic | Placeboa (n=30) | Tadalafila (n=32) | p-Valueb | | Age, year | 39.23±2.45 | 41.37±2.34 | 0.06 | | Height, cm | 175.2±3.35 | 173.46±4.31 | 0.08 | | Weight, kg | 68.13±4.76 | 70.84±6.22 | 0.06 | | Education | 0.95 | | Illiterate | 2 (6.7) | 3 (9.4) | | | Pre-university | 13 (43.3) | 15 (46.9) | | | University | 15 (50.0) | 14 (43.8) | | | Socioeconomic status (monthly income) | 0.57 | | Poor (<7 million Rials) | 10 (33.3) | 9 (28.1) | | | Moderate (7-14 million Rials) | 12 (40.0) | 17 (53.1) | | | Good (>14 million Rials) | 8 (26.7) | 6 (18.8) | | | ED severity (IIEF-5 questionnaire) | 0.85 | | Mild (17-25) | 19 (63.3) | 19 (59.4) | | | Moderate (11-16) | 10 (33.3) | 11 (34.4) | | | Severe (0-10) | 1 (3.3) | 2 (6.2) | |
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Distribution and comparison of basic and clinical demographic characteristics of patients in the two groups.
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| Laboratory data | Placeboa | Tadalafila | p-Valueb | | White blood cell, 103/μL | 7.24±0.97 | 6.85±0.58 | 0.10 | | Hemoglobin, g/dL | 14.87±0.85 | 15.16±0.75 | 0.16 | | Platelets, 103/μL | 229.03±37.11 | 250.12±53.09 | 0.07 | | Testosterone, ng/mL | 5.23±1.07 | 4.95±0.84 | 0.26 | | Fasting blood sugar, mg/dL | 91.23±3.32 | 92.56±2.93 | 0.10 | | Triglyceride, mg/dL | 118.73±16.07 | 125.75±16.01 | 0.09 | | Cholesterol, mg/dL | 165.86±16.79 | 170.46±10.80 | 0.20 | | Alanine aminotransferase, U/L | 18.73±2.85 | 19.37±2.47 | 0.34 | | Aspartate aminotransferase, U/L | 19.73±2.57 | 20.06±1.86 | 0.56 | | Creatinine, mg/dL | 0.92±0.18 | 0.93±0.20 | 0.87 |
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Comparison of laboratory data of patients between the two groups.
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| Sexual function score | Placeboa | Tadalafila | p-Valueb | | Erectile function | | Pre-treatment | 16.86±3.04 | 16.28±2.96 | 0.42 | | Post-treatment | 21.50±3.49 | 26.31±2.81 | 0.0001 | | Δ(Post-Pre) | 4.63±2.0 | 10.0±1.6 | 0.001 | | Orgasmic function | | Pre-treatment | 5.73±1.96 | 5.35±1.73 | 0.41 | | Post-treatment | 7.63±1.47 | 7.56±1.37 | 0.0001 | | Δ(Post-Pre) | 1.9±0.8 | 2.2±0.9 | 0.16 | | Sexual desire | | Pre-treatment | 7.56±1.60 | 7.03±1.71 | 0.21 | | Post-treatment | 8.66±1.42 | 8.97±1.10 | 0.0001 | | Δ(Post-Pre) | 1.1±0.6 | 1.9±1.1 | 0.001 | | Intercourse satisfaction | | Pre-treatment | 5.20±1.51 | 4.97±1.47 | 0.54 | | Post-treatment | 6.37±1.35 | 8.16±1.01 | 0.0001 | | Δ(Post-Pre) | 1.2±0.5 | 3.2±0.7 | 0.001 | | Overall satisfaction | | Pre-treatment | 5.00±1.20 | 4.56±1.66 | 0.24 | | Post-treatment | 6.20±1.56 | 7.12±1.54 | 0.0001 | | Δ(Post-Pre) | 1.2±0.8 | 2.6±0.5 | 0.001 |
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Comparison of the patients' sexual function scores before and after treatment between the two groups based on complete version of International Index of Erectile Function questionnaire.
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Comparison of the patients' sexual domain scores before and after treatment between the two groups based on International Index of Erectile Function questionnaire.
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