Men who take a fixed-dose combination of dutasteride and tamsulosin to manage urinary symptoms associated with an enlarged prostate could be more likely to experience ejaculatory disorders, according to a recent study in BJU International.
Men with benign prostatic hyperplasia (BPH – an enlarged prostate) often develop lower urinary tract symptoms (LUTS). For men with moderate-to-severe LUTS, a fixed-dose combination therapy of dutasteride and tamsulosin (DUT-TAM FDC) is considered the first line therapy if their condition is at risk of progressing. However, this treatment approach can have sexual side effects.
The goal of this study was to assess sexual adverse events of the DUT-TAM FDC approach using a validated instrument, the Male Sexual Health Questionnaire (MSHQ). This tool addresses erection, ejaculation, and satisfaction and includes questions on sexual activity, desire, and distress over sexual dysfunction.
The research was conducted at 51 centers in Europe and Australia and involved 489 sexually active men with LUTS related to BPH who were randomly assigned to receive either DUT-TAM FDC therapy or a placebo for twelve months. The men’s average age was 65 years.
All of the men completed the MSHQ at various time points up to one year as well as other assessments, including the BPH Impact Index (BII) and the International Prostate Symptom Score (IPSS). They also provided information on any adverse events.
Overall, men in the DUT-TAM FDC group saw their MSHQ scores drop between baseline and Month 12, indicating worsening sexual function. The mean decrease was -8.7 points for the treatment group and -0.7 for the placebo group.
The decrease was largely due to poorer scores in the ejaculatory domain, the researchers noted. Differences for the erection and satisfaction domains were small and “unlikely to be clinically relevant,” they wrote.
Men in the DUT-TAM FDC group were more likely to have adverse events as well, especially sexual and breast adverse events (33% compared to 14% in the placebo group). At the end of the treatment period, two thirds of the men in the DUT-TAM FDC group still had unresolved sexual and breast issues. Six months later, such adverse effects did resolve for 44% of the treatment group and 23% of the placebo group.
Unresolved cases of ED after 18 months were “remarkably similar” in the two groups. However, there were more cases of unresolved ejaculatory disorders (such as lower semen volume, retrograde ejaculation, and ejaculation failure) in the treatment group at this time.
The authors noted several limitations. For example, quality of life was not distinctly assessed, and because the study lasted only twelve months, it was unclear how DUT-TAM FDC might affect the men’s sexual function for the long term. The authors also explained that having tamsulosin-only or dutasteride-only groups would have been helpful.
Still, DUT-TAM FDC therapy was associated with improved quality of life in terms of BPH symptoms based on BII and IPSS results, the researchers said. “Therefore, combined therapy was beneficial relative to placebo in treating LUTS in sexually active men with BPH,” they wrote.
Resources
BJU International
Roehrborn, Claus G., et al.
“A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)”
(Full-text. First published: November 16, 2017)
http://onlinelibrary.wiley.com/doi/10.1111/bju.14057/full
Renal and Urology News
Charnow, Jody A.
“Sexual Adverse Effects of BPH Drug Treatment Clarified”
(November 24, 2017)
http://www.renalandurologynews.com/benign-prostatic-hyperplasia-bph/sexual-adverse-effects-of-bph-drug-treatment-clarified/article/709478/