Study Objective: The objective of the clinical survey study is to evaluate the clinical efficacy and safety of Sensum+ treatment for non-circumcised patients with ejaculatory delay due to reduced penile sensitivity (RPS).
Study Design: A total of 14 subjects were enrolled in this study. Patients were selected based on a survey entry questionnaire designed by Centric Research Institute (CRI) to evaluate the extent of reduced penile sensitivity on ejaculation delay in uncircumcised men with or without comorbidity of diabetes. Patients (age 18-year and older) reporting reduced penile sensitivity and delayed ejaculation (MIELT 10 minutes) were selected for enrollment. Based on the entry survey (Appendix 1) during the screening period, subjects with reduced penile sensitivity were encouraged to induce ejaculation by masturbation at three separate events with a minimum of 24 hours between each event and following the stopwatch method to establish a baseline MIELT (Masturbation-Induced Ejaculatory Latency Time). Once the enrollment period is completed, each patient was given 2 dispensers of Sensum+ (150 mg/pump) to apply twice daily on the glans and shaft of the penis with a 12 hour-interval between each application for 2 weeks. Subjects were instructed to abstain from any sexual activity during the first week of treatment. Subjects were asked to gather the efficacy data for penile sensitivity, overall sex life satisfaction and sexual relationship with partner at the end of the treatment period (Appendix 2). During the second week of treatment subjects were instructed to use a stopwatch when masturbating to record the MIELT for at least 3 separate events. During treatment period, subjects were encouraged to record any adverse event by using questionnaire in Appendix 3.
The clinical variables of this study were sensitivity of the penis glans, overall sex life satisfaction, sexual relationship satisfaction with partner and Masturbation-Induced Ejaculatory Latency Time (MIELT). Changes in the penis glans sensitivity were reflected by a rating (Scale 1-10) to the question How would you rate your penile sensitivity (10 being most sensitive, 1 least sensitive) at baseline and after treatment with Sensum+. Answers to How satisfied have you been with your overall sex life satisfaction? and How satisfied have you been with your sexual relationship with your partner were rated on a 1-5 scale, where 1= Very dissatisfied and 5= Very satisfied. Changes in Masturbation-Induced Ejaculation Latency Time (MIELT) at baseline and after treatment were assessed using a stopwatch method (Appendix 1&2). The safety of Sensum+ was evaluated based on adverse events reported by subjects using safety questionnaire (Appendix 3).
Study Result: A total of 14 patients with reduced penile sensitivity and masturbation-induced ejaculatory latency time 10 minutes were enrolled in this study. Based on the clinical report forms (CRFs), 8 patients reported history of diabetes. Clinical efficacy evaluation and safety analysis were performed for all patients who used the product at least once. Survey data analyses indicate that at baseline, the average mean penile sensitivity was rated at 2.57±0.34 (N=14), the MIELT was 1388±125.8 seconds (N=14) and the overall sex life satisfaction and sexual relationship with partner were 1.23±0.12 (N=13). After one week treatment with Sensum+, the mean penile sensitivity was 5.07±0.38 (N=14) (scale 1-10), the overall sex life satisfaction was 4.23±0.23 (N=13) (Scale 1-5) and the sexual relationship with partner was rated at 3.50±0.35 (N=12) (Scale 1-5). The average mean MIELT was 946.8±114.1 seconds (N=6). Statistical analysis of the mean change (Treatment baseline) for the clinical variables was statistically significant with a p value of 0.0001 for penile sensitivity, overall sex life satisfaction and sexual relationship. With respect to the MIELT, the p value was 0.0266. Reports of adverse events indicate that 14.28% (N=2) of subjects reported penile or vaginal burning.
Study Summary: The results from this clinical survey study indicate that twice daily treatment for a period of two weeks with Sensum+ was safe and effective. Sensum+ improved penile sensitivity, decreased ejaculatory latency time and increased users sex life satisfaction and sexual relationship with partner.