Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo‐controlled studies

• Published in: BJU international Vol. 111; no. 2; pp. 334 - 343
• Main Authors: Paduch, Darius A., Bolyakov, Alexander, Polzer, Paula K., Watts, Steven D.
• Format: Journal Article
• Language: English
• Published: Oxford Wiley-Blackwell 01.02.2013; Wiley Subscription Services, Inc
• Subjects: Biological and medical sciences; Carbolines - administration & dosage; Coitus - psychology; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug therapy; ejaculation; Ejaculation - drug effects; epidemiology; erectile dysfunction; Erectile Dysfunction - drug therapy; Erectile Dysfunction - psychology; Gynecology. Andrology. Obstetrics; human; Humans; Male; Male genital diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Non tumoral diseases; orgasm; Patient Satisfaction; Phosphodiesterase 5 Inhibitors - administration & dosage; phosphodiesterases; Randomized Controlled Trials as Topic; Retrospective Studies; Sexual disorders; Sexual Dysfunctions, Psychological - drug therapy; Sexual Dysfunctions, Psychological - psychology; Tadalafil; Nephrology; Vasodilator agent; 3',5'-Cyclic-GMP phosphodiesterase; Impotence; Sexual dysfunction; Satisfaction; Male; Esterases; Phosphoric diester hydrolases; Epidemiology; Urology; erectile dysfunction; Ejaculation; phosphodiesterases; Male genital diseases; Human; Erection disorders; Enzyme; Enzyme inhibitor; Phosphodiesterase inhibitor; Phosphodiesterase 5 inhibitor; Tadalafil; Orgasm; Carboline derivatives; Treatment; Placebo; Hydrolases; Severe
• ISSN: 1464-4096; 1464-410X; 1464-410X
• DOI: 10.1111/j.1464-410X.2012.11656.x

What's known on the subject? and What does the study add? Disorders of ejaculation and orgasm are common, even in men with only mild erectile dysfunction (ED). Treatment with the phosphodiesterase type‐5 inhibitor tadalafil was associated with improvements in ejaculatory and orgasmic function. Patients with residual ejaculatory or orgasmic dysfunction experience reduced sexual satisfaction. These findings need to be corroborated in further clinical trials involving men without ED. Objectives To compare effects of tadalafil on ejaculatory and orgasmic function in patients presenting with erectile dysfunction (ED). To determine the effects of post‐treatment ejaculatory dysfunction (EjD) and orgasmic dysfunction (OD) on measures of sexual satisfaction. Patients and Methods Data from 17 placebo‐controlled 12‐week trials of tadalafil (5, 10, 20 mg) as needed in patients with ED were integrated. EjD and OD severities were defined by patient responses to the International Index of Erectile Function, question 9 (IIEF‐Q9; ejaculation) and IIEF‐Q10 (orgasm), respectively. Satisfaction was evaluated using the intercourse and overall satisfaction domains of the IIEF and Sexual Encounter Profile question 5. Analyses of covariance were performed to compare mean ejaculatory function and orgasmic function, and chi‐squared tests evaluated differences in endpoint responses to IIEF‐Q9 and IIEF‐Q10. Results A total of 3581 randomized subjects were studied. Treatment with tadalafil 10 or 20 mg was associated with significant increases in ejaculatory and orgasmic function (vs placebo) across all baseline ED, EjD, and OD severity strata. In the tadalafil group, 66% of subjects with severe EjD reported improved ejaculatory function compared with 36% in the placebo group (P < 0.001). Similarly, 66% of the tadalafil‐treated subjects (vs 35% for placebo; P < 0.001) with severe OD reported improvement. Residual severe EjD and OD after treatment had negative impacts on sexual satisfaction. Limitations of the analysis include its retrospective nature and the use of an instrument (IIEF) with as yet unknown performance in measuring treatment responses for EjD and OD. Conclusions Tadalafil treatment was associated with significant improvements in ejaculatory function, orgasmic function and sexual satisfaction. Proportions of subjects reporting improved ejaculatory or orgasmic function were ≈ twofold higher with tadalafil than with placebo. These findings warrant corroboration in prospective trials of patients with EjD or OD (without ED).