Abstract
ABSTRACT Objective To evaluate the safety and effectiveness of daily 5-mg tadalafil treatment for men who have erectile dysfunction (ED) and premature ejaculation (PE), and to assess the long-term follow-up for ED and PE improvement persistence years after the cessation of medication. Patients and Methods A prospective, single-blind, randomised study included 160 patients with ED and PE. All were evaluated using the International Index of Erectile Function (IIEF-5) questionnaire to evaluate ED and intravaginal ejaculatory latency time (IELT) for PE. Patients were subdivided into two equal groups. Group I (80 patients) treated with daily 5-mg tadalafil for 3 months, and Group II (80 patients) treated with a placebo for the same period. After 3 months of treatment and 2 years later after cessation of tadalafil, all patients were assessed for ED and PE. Results The mean (SD) IELT and IIEF-5 score pre-treatment were 37 (11.24) s and 13.2 (4.2) for Group I, while in Group II they were 35.98 (10.8) s and 13.12 (4.11), respectively. After 3 months of treatment, the mean (SD) IELT in Group I showed a highly significant improvement from 37 (11.24) s to 120.5 (47.37) s (P < 0.001) but Group II showed no significant improvement from baseline to [39.43 (13.6) s; P > 0.05]. For the IIEF-5 score, there was a highly significant improvement from baseline to 20.45 (4.5) in Group I (P < 0.001), while there was no significant difference in Group II from baseline to [15 (4.84); P > 0.05]. At 2 years after cessation of tadalafil, there was statistically significant improvement in the IELT and IIEF-5 from baseline to endpoint . Conclusion Oral daily 5-mg tadalafil was effective, tolerable, and safe treatment for patients with ED and PE. Long-term follow-up at 2 years confirmed the persistence of a significant improvement for both ED and PE. Abbreviations: ED: erectile dysfunction; IIEF-5: five-item version of the International Index of Erectile Function questionnaire; IELT: intravaginal ejaculatory latency time; OAD: once-daily; PDE5i: phosphodiesterase-5 inhibitors; PE: premature ejaculation; PRN: pro re nata
Highlights
Erectile dysfunction (ED) and premature ejaculation (PE) are the most common sexual dysfunctions where a prevalence of about 30 % and 20 %, respectively1, 2.Erectile dysfunction (ED) is a failure to accomplish and maintain an adequate erection to reach satisfaction with sexual intercourse
Tadalafil 5 mg was effective, tolerable, and safe treatment for patients suffering from ED and PE
Premature ejaculation is defined by International Statistical Classification of Diseases and Related Health problems as the inability to control ejaculation which sufficiently enough to enjoy both partners during sexual intercourse 3
Summary
Erectile dysfunction (ED) and premature ejaculation (PE) are the most common sexual dysfunctions where a prevalence of about 30 % and 20 %, respectively . Erectile dysfunction (ED) is a failure to accomplish and maintain an adequate erection to reach satisfaction with sexual intercourse. Premature ejaculation is defined by International Statistical Classification of Diseases and Related Health problems as the inability to control ejaculation which sufficiently enough to enjoy both partners during sexual intercourse 3. Sexual dysfunction including ejaculatory and orgasmic disorders, ejaculatory disorders including PE, and retarded ejaculation (RE), but orgasmic disorders including anorgasmia and hyporgasmia. According to the predictor factors, the PE is classified into primary or lifelong and secondary or acquired. Organic factors are the commonest predictors for acquired PE like and endocrinal disorder
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