Wednesday April 8 2009
Researchers say the spray improved sexual satisfaction
“A spray helping men last six times longer in bed has been developed by British doctors,” The Sun reported. It said that tests showed the spray increased intercourse from seconds to almost four minutes. The newspaper said a study of 300 men with premature ejaculation used either the spray or a placebo five minutes before sex. Men who used the spray prolonged intercourse from 0.6 minutes to 3.8 minutes, while the placebo group increased to 1.1 minutes.
The men in this study all had lifelong premature ejaculation and the spray would not necessarily have the same effect on men without the condition who simply want sex to last longer. The drug is also not “spray-on Viagra”, as it contains different drugs and, unlike Viagra, is not used to treat erectile dysfunction. Further randomised controlled trials are needed to determine whether the PSD502 spray does have advantages over other treatments, such as behavioural or other drug therapies.
Where did the story come from?
Dr W Wallace Dinsmore from Royal Victoria Hospital, Belfast and Michael G Wyllie from Plethora Solutions Ltd (the company that makes the PSD502 spray) were co-authors of this study. No sources of funding are reported, one author is a director and shareholder of Plethora Solutions Ltd, while the other is a consultant and investigator for the company. The study was published in the peer-reviewed medical journal BJU International.
What kind of scientific study was this?
This was a double-blind randomised placebo controlled trial. Its aim was to examine the effects of the PSD502 spray on length of intercourse (ejaculatory latency) in men with premature ejaculation. The PSD502 spray contained 7.5mg or lidocaine and 2.5mg prilocaine, both of which are local anaesthetics.
The researchers say that although anaesthetic creams are already successfully used to increase intercourse length, they are not specifically designed or licensed for this use and have several shortcomings including mess, a potentially long waiting time and need to use a condom.
The researchers enrolled adult men over 18 years old from 31 centres in Europe (the Czech Republic, Poland, UK and Hungary). All the men were in stable heterosexual monogamous relationships and had been diagnosed with lifelong premature ejaculation according to standard criteria. These criteria defined lifelong premature ejaculation as “a male sexual dysfunction characterised by ejaculation, which always or nearly always occurs prior to or within about one minute of vaginal penetration, an inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration and avoidance of sexual intimacy”.
Men who had erectile dysfunction were excluded from the study. The researchers also excluded men (or their partners) with physical or psychological problems that would interfere with the study. They also disallowed anyone taking antidepressants for conditions other than premature ejaculation and where the dose had been changed in the last four weeks or was going to be changed during the study period. Men with alcohol or drug abuse, a known sensitivity to local anaesthetics, those who had pregnant partners or partners not willing to use contraception during the study, those using certain heart medications, and those with specific medical conditions or medication that would increase risk of safety concerns, were also excluded.
When they enrolled, the participants had a medical examination including heart monitoring, and filled in standard questionnaires about their premature ejaculation, including the Index of Premature Ejaculation (IPE), which includes scores for ejaculatory control and sexual satisfaction, and Premature Ejaculation Profile (PEP). They also rated their orgasms on a five-point scale from ‘very poor’ to ‘very good’.
The 300 men who reported that they ejaculated within one minute of beginning intercourse (from penetration to ejaculation) on at least two out of three occasions in a four-week screening period were randomly assigned to either a placebo spray or the PSD502 spray. The men were instructed to apply the spray onto the penis five minutes before sex and record with a stopwatch how long intercourse lasted on each occasion and any adverse effects. The men were told not to use the spray more than once every 24 hours and not engage in activity that led to ejaculation for at least 24 hours before using the spray. The men were also not allowed to use condoms so that researchers could assess any possible effects of the spray on the men’s partners.
The participants continued to use the sprays under double blind conditions (neither the participants nor the researchers knew which spray they were using) for three months. The men filled in the IPE and PEP questionnaires at monthly clinic visits. At the end of the study, they also rated their orgasms on the five-point scale used at the start of the study, rated the sprays on a four-point scale from ‘poor’ to ‘excellent’ and had their penises examined. The researchers compared the results for the PSD502 spray and the placebo spray.
What were the results of the study?
During the study, 18 patients withdrew from the PSD502 group (out of 200 people) and four withdrew from the placebo group (out of 100 people), mostly due to withdrawal of consent. This left 278 men with an average age of 35 years for analysis.
At the start of the study, men reported that intercourse lasted on average 0.6 minutes. Over the three-month study period, both groups of men reported an increase in the average length of intercourse, but this increase was greater in the PSD502 group: 3.8 minutes in the PSD502 treatment group and 1.1 minutes in the placebo group. This represented a 6.3 fold increase with PSD502 spray and a 1.7 fold increase with placebo.
Men using the PSD502 spray reported greater increases in their ejaculatory control and sexual satisfaction on the Index of Premature Ejaculation questionnaire than those on placebo. At the end of the study, two-thirds (66%) of men in the PSD502 group rated their spray as ‘excellent’ or ‘good’, compared with 15% in the placebo group.
There were no serious adverse events but about 3% of men and 3% of their partners in the PSD502 group and 1% of men in the placebo group reported adverse events that were judged to be treatment-related. None of the partners of the men in the placebo group reported adverse events. The most common adverse events in the PSD502 group included redness of the genitals, loss of erection, and a burning sensation in the genitals in their partners.
What interpretations did the researchers draw from these results?
The researchers concluded that PSD502 delayed ejaculation and improved control of ejaculation. They say it improved sexual satisfaction in men with premature ejaculation and appears to be well tolerated. They conclude, “PSD502 therefore appears to offer significant advantages over other therapies in development for the treatment of [premature ejaculation].”
What does the NHS Knowledge Service make of this study?
This study indicates that the PSD502 spray can delay ejaculation in men with lifelong premature ejaculation. Its strengths include its relatively large size, randomised design, and use of double blinding and a placebo control group. There are a number of points to note:
- This study included only men with a lifelong diagnosis of premature ejaculation and the results may not be representative of what would occur in men who have only occasional premature ejaculation or just want to delay ejaculating.
- Although there was a placebo control group, men may have been able to guess which treatment they were using, as the PSD502 spray contains local anaesthetics and is likely to produce a numbing sensation. If the participants guessed which spray they were using, this could affect their rating of their sexual satisfaction and ejaculatory control.
- There may be some measurement error in the timing of intercourse, as this was timed by the participants themselves. This would be likely to affect both groups.
Further randomised controlled trials will be needed to determine whether the PSD502 spray does offer advantages over other treatments for premature ejaculation, such as behavioural or other drug therapies.