Efficacy of Long-Term Daily Dosage of Alfuzosin 10 mg upon Sexual Function of Benign Prostatic Hypertrophy Patients: Two-Year Prospective Observational Study

Yoon, Sol; Choi, Jae-Won; Lee, Seung Hyun; Choi, Seung-Myung; Jeh, Seong Uk; Kam, Sung Chul; Hwa, Jeong Seok; Kihan, Chung; Hyun, Jae Seog

doi:10.5534/wjmh.2014.32.3.133

Cited by 4 publications

(7 citation statements)

References 20 publications

(18 reference statements)

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“…Previous studies have shown the sensitivity of total MSHQ scale scores to both diagnostic status and treatment conditions . The ejaculation domain subscale of the MSHQ has shown treatment sensitivity to pharmacological and other treatments of BPH , although a minimum clinically meaningful change in ejaculation has yet to be determined.…”

Section: Discussionmentioning

confidence: 99%

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)

et al. 2017

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ObjectiveTo prospectively assess the impact of the fixed-dose combination (FDC) of the 5a-reductase inhibitor (5ARI), dutasteride 0.5 mg and the a 1 -adrenoceptor antagonist, tamsulosin 0.4 mg (DUT-TAM FDC) therapy on sexual function domain scores in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), using the Men's Sexual Health Questionnaire (MSHQ). Patients and MethodsThis European and Australian double-blind, placebocontrolled, parallel-group study was conducted at 51 centres. Inclusion criteria: age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen 1.5-10 ng/mL. Patients were randomised 1:1 to DUT-TAM FDC therapy or placebo for 12 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains (secondary outcome) was assessed, using a mixed model repeated measures analysis. Safety was evaluated. ResultsThe intention-to-treat population included 489 patients (243 DUT-TAM FDC therapy; 246 placebo). A significant decrease (worsening) was observed with DUT-TAM FDC therapy versus placebo on the total MSHQ score (À8.7 vs À0.7; standard error [SE]: 0.81, 0.78; P < 0.001), and the ejaculation (À7.5 vs À0.6; SE: 0.56, 0.55; P < 0.001) and satisfaction (À0.6 vs +0.3; SE: 0.3, 0.29, P = 0.047) domains, but not the erection domain (À1.0 vs À0.5; SE: 0.19, 0.19, P = 0.091). ConclusionThis is the first domain-specific quantitative evaluation of DUT-TAM FDC therapy on sexual function in men with LUTS secondary to BPH. The observed changes in the MSHQ with DUT-TAM FDC therapy were mainly driven by changes in the ejaculation domain. These findings will help give context to erectile and ejaculatory dysfunction AEs reported spontaneously in earlier 5ARI studies.

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Section: Discussionmentioning

confidence: 99%

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)

et al. 2017

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“…MSHQ-EjD and IPSS were measured at baseline and after treatment was commenced, however follow-up time varied. All trials were conducted over multiple centres across Asia with the exception of Yoon et al [ 15 ]. Individual sample sizes varied with largest trial in Tunisia assessing 730 patients [ 16 ], while the others had less than 200 patients each.…”

Section: Resultsmentioning

confidence: 99%

“…A number of similarities between these studies regarding patient selection criteria, intervention protocol and outcomes measured was observed. Kim et al [ 17 ] had the shortest intervention time, re-assessing men after just 3 months of treatment, while Yoon et al [ 15 ] followed their patients up to 2 years after commencement of treatment. In addition to the above six papers, Martín-Morales et al [ 18 ] also met inclusion criteria, however published data was incomplete.…”

Section: Resultsmentioning

confidence: 99%

“…All studies showed that LUTS improved after treatment of 6 months (except Kim et al [ 17 ] which demonstrated improvement after 3 months). While the change in score after 6 months was used for Yoon et al's study [ 15 ] for uniformity, their results showed a continuous improvement in IPSS score at 2 years of treatment. In this study, the mean IPSS at month of treatment was 20, compared to 11.5 after 2 years of treatment.…”

Section: Resultsmentioning

confidence: 99%

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Alfuzosin and Its Effect on Ejaculatory Dysfunction: A Systematic Review

Yeung

Sena

Calopedos

et al. 2021

World J Mens Health

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Studies have demonstrated that alfuzosin not only improves lower urinary tract symptoms (LUTS) but also appears to preserve ejaculatory dysfunction (EjD). The objective of this study was to evaluate the impact of alfuzosin on ejaculatory function using the ‘Male Sexual Health Questionnaire (MSHQ)-EjD Short Form’ – a validated, abridged-version of the 25-item MSHQ specifically assessing EjD. A systematic search of MEDLINE, PubMed, Scopus, Embase, and grey literature was performed in January 2017 to identify relevant cohort studies. Search terms were ‘alfuzosin’, ‘benign prostatic hyperplasia’, ‘ejaculatory dysfunction’ and their synonyms without exclusions. Six cohort studies conducted between 2008 to 2015 were selected for analysis. Three of these were conducted in Korea, one in Thailand, one in China, and one in Tunisia. Overall, 1,371 patients were enrolled in these studies with a median age of 62.3 years. All studies quantified patient LUTS and ejaculatory function using the International Prostate Symptom Score (IPSS) and MSHQ-EjD Short Form, respectively. IPSS had a median decrease of 6.6 while MSHQ-EjD had a median increase of 1.9. This review highlights the very real association between sexual function and LUTS. This systematic review confirms that alfuzosin may improve ejaculatory function in addition to LUTS and should be considered in men who are sexually active or who already complain of deteriorating ejaculation.

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“…Regarding ejaculation‐related SexAEs, most patients across both treatment groups reporting these SexAEs had worsening MSHQ ejaculation domain scores at month 12. The ejaculation domain subscale of the MSHQ has shown treatment sensitivity to pharmacological and other treatments of BPH, although a minimum clinically meaningful change in ejaculation has yet to be determined.…”

Section: Discussionmentioning

confidence: 99%

Men’s Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of a prospective, randomised, placebo‐controlled study

Roehrborn

Rosen

Manyak³

et al. 2020

Int J Clin Pract

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Summary Aim To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia. Methods This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT‐TAM FDC), or placebo. End‐points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs. Results The intent‐to‐treat population comprised 489 patients (DUT‐TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT‐TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT‐TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT‐TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6‐10 points in the total MSHQ score were more likely to report SexAEs. Conclusion Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT‐TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.

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Efficacy of Long-Term Daily Dosage of Alfuzosin 10 mg upon Sexual Function of Benign Prostatic Hypertrophy Patients: Two-Year Prospective Observational Study

Cited by 4 publications

References 20 publications

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)

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)

Alfuzosin and Its Effect on Ejaculatory Dysfunction: A Systematic Review

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