Benign Prostatic Hyperplasia (BPH)

Evaluating the impact of dutasteride-tamsulosin combination therapy on sexual function

This double-blind, placebo-controlled, parallel-group study in sexually active men with LUTS/BPH investigated the effects of fixed-dose dutasteride/tamsulosin combination treatment vs placebo on sexual function domains. 1

Patients (n=489) were aged ≥50 years, with IPSS ≥12, prostate volume ≥30 cc and PSA 1.5–10 ng/mL.1 They were randomised (1:1) to QD combination therapy (dutasteride 0.5 mg and tamsulosin 0.4 mg) (n=243) or placebo (n=246) for 12 months, following a 4-week placebo run-in 1

Men with unresolved sexual AEs at the end of the study (after discontinuation of treatment) were followed-up by telephone call at 6 months. 1

Sexual function was assessed using the MSHQ, a validated, self-administered questionnaire assesings specific aspects of male sexual function. 1-3

The study primary endpoint was change from baseline to Month 12 in total MSHQ score. Secondary endpoints included changes in total MSHQ at Months 1, 3, 6, and 9, and at 1, 3, 6, 9 and 12 months in the MSHQ subdomains of erection, ejaculation and satisfaction. 1

Post-hoc analysis of the sexual function study

A post-hoc analysis assessed the effects on MHSQ sexual activity, desire and bother domain scores, at Months 1, 3, 6, 9, and 12. 4

Impact of fixed-dose combination therapy vs placebo at Month 12 on sexual function domains

Mean total MSHQ score (the primary endpoint) was significantly worse at 12 months with combination treatment vs placebo (-8.7 vs -0.7; p<0.001). 1

Changes in the total MSHQ score were driven mainly by changes in the ejaculation domain. 1

At no point in the study were there significant differences between groups for the erection domain. 1

Satisfaction, sexual activity and bother scores were significantly worse at 12 months vs baseline, but these are small differences and unlikely to be clinically relevant 1 4