Topical Spray May Improve Symptoms of Premature Ejaculation

Principessa

Expert Member
Joined
Nov 22, 2006
Posts
18,660
Media
0
Likes
138
Points
193
Sexuality
100% Straight, 0% Gay
Gender
Female
Topical Spray May Improve Symptoms of Premature Ejaculation

April 13, 2009 — For patients with premature ejaculation (PE), a new topical spray, PSD502 (topical eutectic-like mixture for premature ejaculation; Tempe, Plethora Solutions), applied 5 minutes before intercourse, improved ejaculatory latency and control and sexual satisfaction and was well tolerated both by patients and partners, according to the results of a phase 3, multicenter, double-blind, placebo-controlled study reported in the April issue of BJU International. PSD502, a topical agent designed specifically to treat PE, consists of a metered-dose aerosol formulation of lidocaine (7.5 mg) and prilocaine (2.5 mg) dissolved in a nonchlorofluorocarbon propellant.In the treatment phase of the trial, 300 men from 31 centers in Europe were randomized, and 290 actually received treatment. During the 3-month treatment period, mean IELT increased from a baseline of 0.6 minutes in both groups to 3.8 minutes in the PSD502 group (range, 0.3 – 57.8 minutes) compared with 1.1 minutes in the placebo group (range, 0 – 15.0 minutes), representing a 6.3-fold and 1.7-fold increase, respectively, in geometric means adjusted for treatment-group imbalances.Compared with the placebo group, the PSD502 group had significantly greater increases in the scores for the IPE domains of ejaculatory control and sexual satisfaction, with mean difference between treatments of 7.0 ± 0.59 points in change from baseline in the IPE domain for ejaculatory control and 5.9 ± 0.57 points in change from baseline in the IPE domain for sexual satisfaction (both P < .001). All secondary endpoints also showed improvements for PSD502 vs placebo.PSD502 was rated as "good" or "excellent" by 66% of patients at the end of the treatment period, and it was well tolerated. Although no systemic adverse events were reported, localized treatment-related adverse events were reported by 2.6% of patients and 3.1% of partners."PSD502 applied topically 5 min before intercourse improved ejaculatory latency and significantly improved ejaculatory control and sexual satisfaction, factors relevant for acceptance of a PE treatment by both patient/physician and regulatory authorities," the study authors write. "PSD502 was well tolerated by both patients and partners, with no systemic side-effects and a low incidence of localized effects, and was rated favourably by most users. PSD502 therefore appears to offer significant advantages over other therapies in development for the treatment of PE."


According to Dr. Abdel-Hamid, the main strengths of this study include the use of objective methods to document improvements in sexual function, prospective measurement of IELT and recording in a diary card, log-transformation of IELT data for analysis and back transformation for the presentation of results, and use of appropriate statistics.




However, Dr. Abdel-Hamid pointed out the major limitations of the study:
  • Poor selection criteria, as 95% of patients in both groups had lifelong PE — indicating that acquired PE patients were included — and 95% of men in both groups were uncircumcised, raising the issue of the effect of circumcision. In addition, 10% to 20% of patients used both pharmaceutical and nonpharmaceutical therapy for the treatment of erectile dysfunction (ED), indicating that some of them had a history of ED, although the study stated that men with concomitant ED were excluded using the International Index of Erectile Function (IIEF-5) questionnaire.
  • The number of patients was too small to justify the trial as phase 3, as this phase must include 1000 or more patients and not just 290 patients, as were treated with study drug or placebo in this trial. PE is the most common sexual disorder, and other trials of potential PE treatments, such as that of dapoxetine, enrolled 1162 patients from 22 countries in phase 3.
  • The authors did not mention the period of time during which this study was undertaken, raising the question of whether the ISSM definition was used from the start for all patients or was used only for some patients, as this definition was issued in 2008. If the study used the ISSM definition from the start, that definition is quite sufficient, and it was not essential to use DSM-IV criteria, as stated in the study.
  • The study stated that men with PE and their partners were recruited from 31 sites across Europe, but the majority of patients (242) were recruited from 2 countries (Czech Republic and Poland).
  • The study permitted use of lubricating gels and pessaries, which may affect the results, as these materials may have a placebo effect.
  • The authors did not explain in the discussion why in the study group there was a substantial increase in the proportion of men rating the quality of their orgasms as "good" or "very good."
 

javyn

Experimental Member
Joined
Apr 29, 2008
Posts
1,015
Media
4
Likes
14
Points
123
Or....just take the time and effort to learn a little dick control. It's not that difficult. Geeze.