Correlation of changes in IELT and indices of sexual satisfaction in PE patients
Wyllie, MG1; Sharlip, I2
1: GPC Ltd, United Kingdom; 2: UCSF
Objective: Examination of the relationship between Intravaginal Ejaculation Time (IELT) and qualitative questionnaire-captured responses in subjects with premature ejaculation (PE)
Material and Methods: Analysis of data from 2 phase III placebo-controlled studies on Fortacin in the treatment of the signs and symptoms of PE. Parameters measured were IELT and the “Control”, “Satisfaction” and “Distress” domains of the Index of Premature Ejaculation (IPE) in responses from 539 subjects. Fortacin prn was applied to the glans penis 5 to 15 min prior to sexual intercourse.
Results: At baseline, the geometric mean IELT was 0.58 in the active group. At month 1 this increased to 2.4 mins with further increases to 2.8 and 3.1 mins at months 2 and 3, respectively. In a baseline- matched placebo group there were highly statistically different increases at all measurement points (p<0.001). Overall, 87% of patients were considered to be responders i.e. no longer were within the ISSM definition of PE. Of these, almost all gave a good response on the first treatment with Fortacin. The maximum observed IELT in the placebo group at any period was 0.86min. In the active group, similar trends were observed for all 3 domains. with Control at baseline increasing from 4.9 to 11.3, 12.5 and 13.1 over the 3-month measurement period. The equivalent results were 6.9, 12.8, 13.5 and 14.8 for Satisfaction and 1.5, 2.5, 2.7 and 2.9 for the Distress domain. At all measurement points changes were highly statistically different (p<0.001) from the baseline.
Conclusions: As has been described previously, Fortacin produced highly statistically significant improvements in IELT and IPE domains. The present analysis demonstrates that, at least over the first three months, there is an additional improvement in IELT with continued use. Although, not presented here further improvement was observed over the next 9 months with certainly no evidence of tachyphylaxis. Importantly, not only were there clinically important changes in all domains of the IPE but the continued additional improvement with use was also apparent. It is likely that the observed phenomenon arises due the impact of effective therapy on overall sexual confidence and relationship. However, the most important observation is that there is a good correlation between increased IELT and the overall sexual experience (at least as captured by the IPE). This type of information is important in setting patient and partner expectations.
Work supported by industry: yes, by Plethora Solutions (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.Go Back