Study Objective: The objective of the current study is to evaluate the clinical efficacy and safety of Sensum+ treatment for patients with reduced penile
Study Design: Patients were selected based on an online survey (Questions 1-8, Appendix 1). Patients who fulfilled the age (18-year and older) and symptoms of reduced penile sensitivity criteria were selected for enrollment. After the screening preparation, which included the collection and evaluation of the patients sexual function information, Sensum+ was shipped by mail to each patient with instructions on how to apply the product and complete the surveys (Appendix 1 & 2). Patients were instructed to apply Sensum+ twice daily for the first two weeks (12 hour interval) followed by once daily for the remaining eight weeks. At the end of treatment period, patients were asked to complete the efficacy questions (9 & 10, Appendix 1) and safety survey (Appendix 2). Efficacy data are presented in percent patients who achieved improvement for penile sensitivity and who answered yes to improvement of ejaculatory time. The safety of the study product was based on reported adverse events (Appendix 2).
Clinical Result: In this study, a total of 368 patients who met the age ( 18-year old male) and symptoms of reduced penile sensitivity criteria were enrolled in this study. Clinical efficacy evaluation and safety analysis were performed for all patients who used the product. Survey data analyses indicate that 80% (296) of the men surveyed reported an increase in sensitivity after application of Sensum+ and 77.4% (285) of men reported faster ejaculation time. There were no adverse events reported by the users or their partners.
Study Result: The results from the online survey study indicate that 10-week treatment with Sensum+ improved penile sensitivity and decreased ejaculatory time. The application of Sensum+ for patients with reduced penile sensitivity was safe and effective.