To date, no scoring system has adequately defined clinical efficacy of erectile dysfunction (ED) therapies when evaluating differences between cohorts or in meta-analytic studies.
To outline the minimal criteria required for any therapy to be considered clinically effective in the treatment of ED.
An analytic review was performed of standardized ED questionnaires, with a particular emphasis placed on the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD), and the minimally clinically important difference (MCID) concept. The data were used to create a societal position statement and recommendations on best practices within clinical trials to determine treatment efficacy.
The SMSNA provided 6 key statements and recommendations to suggest best practices and define minimal thresholds for improvements required for an ED therapy to be considered clinically effective.
The IIEF-EFD currently represents the preferred standardized questionnaire to evaluate for changes in erectile function post-treatment and is the only questionnaire adequate to assess primary outcomes. To claim efficacy, investigational treatments must demonstrate MCID between cohorts (eg, 2-, 5-, or 7-point median improvements between groups among mild, moderate, or severe ED cohorts) in prospective, randomized, placebo-controlled, and adequately powered studies. In studies employing mixed-severity ED populations, a method of calculating an adjusted MCID was proposed based on statistical weighting principles. Similarly, a novel method for analyzing differences between cohorts in meta-analytic studies was presented to incorporate the concept of MCID. Based on these principles, the SMSNA would not support efficacy of a therapy based on statistical significance in a meta-analytic study alone. Similarly, studies claiming efficacy utilizing responder approaches (ie, statistically higher percentage of men achieving MCID between cohorts) would not be acceptable unless the median difference between groups on the IIEF-EFD achieved MCID.
The current position statement provides important, evidence-based data and scientific principles to help define what may be considered as an effective therapy in the treatment of ED. This framework provides a basis that decision-makers, clinicians, and patients may use to help differentiate clinically effective therapies.
The published literature is limited by a lack of validated instruments and data defining MCID for ED therapies between cohorts and with meta-analytic studies. The current position statement provides important guidance on these areas of ambiguity pending further, definitive data.
The current position statement provides detailed guidance on key criteria required to conclude efficacy of therapies used to treat ED.
The journal of sexual medicine. 2026 Feb 06 [Epub]
Landon Trost, Faysal Yafi, Alan Shindel, Mohit Khera, Raymond C Rosen, Petar Bajic, Helen Bernie, Martin Gross, Johanna Hannan, Sevann Helo, Lawrence Jenkins Ii, Carol Podlasek, Daniel Watter, Matthew Ziegelmann, Tobias Köhler
Male Fertility and Peyronie's Clinic, Orem, UT 84057, United States., University of California, Department of Urology, Irvine, Irvine, CA 92697, United States., University of California, Department of Urology, San Francisco, San Francisco, CA 94143, United States., Baylor College of Medicine, Department of Urology, Houston, TX 77030, United States., Adjunct Full Professor of Psychiatry and Behavioral Science, UCSF School of Medicine, San Francisco, California, United States., Cleveland Clinic, Department of Urology, Cleveland, OH 44195, United States., Indiana University, Department of Urology, Indianapolis, IN 46202, United States., Geisel School of Medicine, Section of Urology, Dartmouth College, Lebanon, NH 03755, United States., University of Wisconsin, Department of Urology, Madison, WI 53705, United States., Mayo Clinic, Department of Urology, Rochester, MN 55905, United States., Tulane University, Department of Urology, New Orleans, LA 70112, United States., University of Illinois at Chicago, Departments of Urology, Physiology, Bioengineering and Biochemistry, Chicago, IL 60612, United States., Morris Psychological Group, P.A., Parsippany, NJ 07054, United States.