An analysis of treatment preferences and sexual quality of life outcomes in female partners of Chinese men with erectile dysfunction

Abstract

The impact of erectile dysfunction is distressing to both males and their female partners, but less attention has been paid to identify female partners' preferred treatment and sexual quality of life outcomes. The present analysis explores female partners' treatment preference for erectile dysfunction in Chinese Men. This was a phase 4, randomized, open-label, multicenter, crossover study in Chinese men with erectile dysfunction who were naïve to phosphodiesterase type 5 inhibitor treatments. Eligible patients were randomized to sequential 20-mg tadalafil/100-mg sildenafil or 100-mg sildenafil/20-mg tadalafil for 8 weeks each. Of 418 patients, female partners of 64 patients agreed to enter the study; of 64 patients who entered the study with female partners, 63 were randomized, and 62 completed the study. Baseline demographics and disease characteristics were comparable between treatment groups. Significantly more couples preferred tadalafil compared with sildenafil overall (75.4% vs 24.6%; P < 0.001), and irrespective of erectile dysfunction severity at baseline (P ≤ 0.005). Significant improvements in sexual quality of life scores were reported at endpoint (Visit 8) in male patients and female partners in both tadalafil and sildenafil treatment groups (P < 0.001). Significantly higher mean changes from baseline were observed for male patients in the tadalafil group compared with the sildenafil group for the erectile function (P = 0.013) and overall satisfaction (P = 0.019) International Index for Erectile Function domains and the spontaneity domain (P < 0.001) of the Psychological and Interpersonal Relationship Scale. No major safety concerns were reported during the study. Though both treatments were effective, safe, and tolerable, more couples preferred tadalafil compared with sildenafil.

Figure 1

Study design – Randomized patients received 8 weeks of treatment with tadalafil or sildenafil PRN. After 8 weeks of treatment, followed by a wash-out period of 7 to 10 days, the patients crossed over to the opposite treatment for another 8 weeks followed by an 8-week extension period. Abbreviations: DRAQ: drug attribute questionnaire; IIEF: international index of erectile function; PAIRS: psychological and interpersonal relationship scale; PITPQ: phosphodiesterase 5 inhibitor treatment preference questionnaire; PRN: pro re nata (on demand); QoL: quality of life; SEP: sexual encounter profile; SLQQ: sexual life quality questionnaire; THX: treatment satisfaction; V: visit. ^aWash-out period is 7 to 10 days; up to 10 days have been included in the timeline (i.e., 1.5 weeks). The number of weeks has been rounded up to the nearest integer. bAt screening and baseline, the patient and partner answered the 10-item QoL domain, as the study treatment was not administered. At the end of the extension phase, the complete SLQQ was administered, both QoL and THX domain.