Tadalafil Once Daily Improves Ejaculatory Function, Erectile Function, and Sexual Satisfaction in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia and Erectile Dysfunction: Results from a Randomized, Placebo- and Tamsulosin-Controlled, 12-Week Double-Blind Study

Abstract

Introduction Tadalafil, a long-acting phosphodiesterase type 5 inhibitor, is approved for treating signs and symptoms of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED); tamsulosin, an alpha-blocker, is approved for treating signs and symptoms of BPH. Aim To determine the effects of tadalafil or tamsulosin on sexual function, including ejaculation and orgasm, satisfaction, and erectile function, in sexually active men with ED and lower urinary tract symptoms suggestive of BPH (LUTS/BPH). Methods A randomized, double-blind, placebo-controlled study of tadalafil 5mg once daily for 12 weeks in men with LUTS/BPH; tamsulosin 0.4mg once daily was an active control. Main Outcome Measures The International Index of Erectile Function (IIEF) questionnaire was administered at baseline and 4, 8, and 12 weeks. Analysis of orgasm and ejaculation was post hoc based on the IIEF-Orgasmic Function (OF) domain (IIEF-Q9 [ejaculatory frequency] and Q10 [orgasmic frequency]). Other measures included IIEF-Intercourse Satisfaction (IS), Overall Satisfaction (OS), and Erectile Function (EF) domains. Changes from baseline to 12 weeks (or last observation) vs. placebo were analyzed using analysis of covariance. Higher IIEF scores indicate better functioning. Results Of 511 study participants, 310 (60.7%) had ED and were sexually active. The IIEF-OF increased significantly through 12 weeks with tadalafil vs. placebo (P =0.048), as did IIEF-Q9 (P =0.045) but not IIEF-Q10 (P =0.100). Compared with placebo, IIEF-OF, Q9, and Q10 decreased significantly with tamsulosin (all P <0.05). The IIEF-IS and OS increased significantly at end point with tadalafil (both P <0.001); for tamsulosin, change was not significant for IS, while OS decreased significantly (P =0.009). The IIEF-EF domain increased significantly vs. placebo with tadalafil (P <0.001) but not tamsulosin (P =0.699). Conclusions Tadalafil 5mg once daily significantly improved ejaculation and orgasm, intercourse and overall satisfaction, and erectile function. Men receiving tamsulosin 0.4mg once daily experienced a decrease in both ejaculatory/orgasmic frequency and overall satisfaction vs. placebo, with no significant effect on erectile function.

Tadalafil Improves Symptoms, Erectile Function and Quality of Life in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (KYU‐PRO Study)

“…), which is not consistent with the previous studies . As shown in Table , the mean age of participants was 67.3 years (range: 48–86 years) and the majority (71.4%) of participants were older than 65 years, which is relatively high compared to the previous studies . In addition, the baseline IIEF5 score (11.2 ± 1.2) was relatively low compared to the previous studies, suggesting that our patients were older and had more severe ED.…”

“…However, this improvement was not continued throughout the following treatment period (Fig. ), which is not consistent with the previous studies . As shown in Table , the mean age of participants was 67.3 years (range: 48–86 years) and the majority (71.4%) of participants were older than 65 years, which is relatively high compared to the previous studies .…”

Tadalafil in the management of lower urinary tract symptoms: a review of the literature and current practices in Russia

“…The magnitude of improvement in total IPSS at the 12–week endpoint with tadalafil was comparable to that with tamsulosin and consistent with other reports [33, 37, 38]. As measured by IIEF–EF, tadalafil significantly improved erectile function (P <.001) compared with placebo in sexually active men with ED (approximately 60% of subjects), while tamsulosin did not (P = .699) [42, 43]. Overall, evidence from this study indicates that tadalafil 5 mg or tamsulosin 0.4 mg once–daily results in similar improvements in LUTS/BPH symptoms at 12 weeks.…”

Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double‐blind, placebo‐controlled studies

“…[14][15][16] The results from these three Asian studies were also comparable with pivotal clinical studies of tadalafil in American and European men with BPH/LUTS. [17][18][19][20][21][22] The incidence/severity of BPH/LUTS has been shown to increase with increasing age; additionally, LUTS patients experience varying degrees of symptom severity, have comorbid conditions, or have prior exposure to BPH treatments, all of which might impact the efficacy of new therapies. [23][24][25] As individual studies, the three aforementioned trials were insufficiently powered to analyze patient subgroups.…”