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Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group

Tan HM, Moh CL, Mendoza JB, Gana T, Albano GJ, de la Cruz R, et al.

Urology, 2000 Oct 1;56(4):635-40.
PMID: 11018621 DOI: 10.1016/s0090-4295(00)00688-9

OBJECTIVES:
To evaluate the efficacy, safety, and tolerability of oral sildenafil in Asian men with erectile dysfunction of various causes (organic, psychogenic, or mixed) and of more than 6 months' duration.

METHODS:
In this double-blind, parallel-group trial conducted at eight centers in Malaysia, the Philippines, and Singapore, 254 men, 26 to 78 years old, were randomized to 12 weeks of sildenafil or placebo taken as needed 1 hour before anticipated sexual activity. Initially, the sildenafil (n = 127) or matching placebo (n = 127) dose was 50 mg but could be increased to 100 mg or decreased to 25 mg because of a lack of efficacy or intolerance, respectively. Efficacy was assessed by the 15-question International Index of Erectile Function, patients' event logs of sexual activity, and a global efficacy question about erections.

RESULTS:
The two primary efficacy variables relating to achievement and maintenance of an erection sufficient for sexual intercourse, as assessed by the mean scores for International Index of Erectile Function question 3 (4.22 versus 2.59) and question 4 (4.15 versus 2.41), were both significantly higher with sildenafil than with placebo (P <0.0001). In addition, the five separate International Index of Erectile Function domains of sexual function, the percentage of successful intercourse attempts, and the global efficacy assessment of erections revealed significantly greater treatment effects in favor of sildenafil (P <0.0001 versus placebo for all variables). Treatment-related adverse events occurred in 22.8% of patients who received sildenafil and in 10.2% of those who received placebo.

CONCLUSIONS:
Sildenafil is an effective and well-tolerated treatment for Asian men with erectile dysfunction of broad-spectrum etiology.
Fulltext Consensus and Diversity in the Management of Varicocele for Male Infertility: Results of a Global Practice Survey and Comparison with Guidelines and Recommendations

Shah R, Agarwal A, Kavoussi P, Rambhatla A, Saleh R, Cannarella R, et al.

World J Mens Health, 2023 Jan;41(1):164-197.
PMID: 35791302 DOI: 10.5534/wjmh.220048

PURPOSE: Varicocele is a common problem among infertile men. Varicocele repair (VR) is frequently performed to improve semen parameters and the chances of pregnancy. However, there is a lack of consensus about the diagnosis, indications for VR and its outcomes. The aim of this study was to explore global practice patterns on the management of varicocele in the context of male infertility.
MATERIALS AND METHODS: Sixty practicing urologists/andrologists from 23 countries contributed 382 multiple-choice-questions pertaining to varicocele management. These were condensed into an online questionnaire that was forwarded to clinicians involved in male infertility management through direct invitation. The results were analyzed for disagreement and agreement in practice patterns and, compared with the latest guidelines of international professional societies (American Urological Association [AUA], American Society for Reproductive Medicine [ASRM], and European Association of Urology [EAU]), and with evidence emerging from recent systematic reviews and meta-analyses. Additionally, an expert opinion on each topic was provided based on the consensus of 16 experts in the field.
RESULTS: The questionnaire was answered by 574 clinicians from 59 countries. The majority of respondents were urologists/uro-andrologists. A wide diversity of opinion was seen in every aspect of varicocele diagnosis, indications for repair, choice of technique, management of sub-clinical varicocele and the role of VR in azoospermia. A significant proportion of the responses were at odds with the recommendations of AUA, ASRM, and EAU. A large number of clinical situations were identified where no guidelines are available.
CONCLUSIONS: This study is the largest global survey performed to date on the clinical management of varicocele for male infertility. It demonstrates: 1) a wide disagreement in the approach to varicocele management, 2) large gaps in the clinical practice guidelines from professional societies, and 3) the need for further studies on several aspects of varicocele management in infertile men.

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