Standards for Clinical Trials in Male Sexual Dysfunctions

Abstract

Introduction Clinical trials in male sexual dysfunction (MSD) are expanding. Consequently, there is a need for consensus standards in this area. Aim To develop an evidence-based, state-of-the-art consensus report on standards for clinical trials in MSD. Methods A literature review was performed examining clinical trials in erectile dysfunction (ED), premature ejaculation (PE), delayed/absent ejaculation, libido disorders/loss of desire, hypogonadism, and Peyronie’s disease, focusing on publications published in the last 20 years. This manuscript represents the opinions of eight experts from seven countries developed in a consensus process. This document was presented for peer review and debate in a public forum and revisions were made based on recommendations of chairpersons to the International Consultation on Sexual Medicine. Main Outcome Measure Expert opinion was based on the grading of evidence-based medical literature, widespread internal committee discussion, public presentation, and debate. Results According to experience and recent publications in dealing with clinical trials in sexual dysfunction, recommendations have been made for conducting trials in patients with ED, PE, delayed ejaculation, libido disorders, hypogonadism, and Peyronie’s disease. Conclusions It is important that future clinical trials are conducted using standards upon which investigators can rely when reading manuscripts or conducting new trials in this field.

Twelve-Month Efficacy and Safety of Low-Intensity Shockwave Therapy for Erectile Dysfunction in Patients Who Do Not Respond to Phosphodiesterase Type 5 Inhibitors

“…The following evaluation criteria were used: IIEF-EF to assess ED severity, questions 2 and 3 from the Sexual Encounter Profile (SEP2 and SEP3) to assess penetration and erection sustainability, the Erection Hardness Score (EHS), and a Global Assessment Question (GAQ): Has the treatment improved the quality of your erections?26, 27, 28, 29…”

Intralesional Injections for Early Peyronie Disease: Standardized Assessment and Analysis of Predictive Factors for Treatment Response

“…In the past few years, numerous authors have advocated the use of standardized and validated symptom scores to report outcomes of PD treatment. 12,[19][20][21] The Lue score was proposed by Lue et al in 2004 14 to measure, quantitatively and objectively, the impact of treatments on PD. In recent years, several authors have used this score to report treatment outcomes in the setting of PD, 22 but the role of each treatment remains unclear.…”

Escitalopram treatment for premature ejaculation has a negative effect on semen parameters

“…6,15,16 The ideal diagnostic method for PE remains to be unclear, however, recent guidelines suggest to combine stopwatch measured IELT with patient-reported outcome questionnaires in clinical trials. 7,17,12 Several studies used PEDT in combination with IELT to evaluate the efficacy of SSRIs in the treatment of PE. 18,19 Managing PE has been a challenge for physicians as well because no drug for PE has been approved by FDA and EMEA.…”