Tuesday, March 21, 2023
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Editor's Note:
Unsatisfying sex is not the only effect of premature ejaculation (PE); it can create serious distress for both partners, which
can ultimately jeopardize a relationship. Where do we stand at the moment in our ability to diagnose and treat this problem?
David McNeel, Medscape Urology, interviewed Stanley E. Althof, PhD, Professor of Psychology at Case Western Reserve University
School of Medicine in Cleveland, Ohio, and Director of The Center for Marital and Sexual Health of South Florida, West Palm
Beach, Florida.
Medscape: Here at the 11th World Congress of the International Society for Sexual and Impotence Research, we've just heard a series of fascinating presentations on the subject of PE, a subject that Dr. Althof has been studying and publishing on for more than a decade. Dr. Althof, in today's presentations we heard a lot of widely varying estimates about the prevalence of PE. Is there a generally accepted estimate of the number of men affected?
Dr Althof: The short answer is no, and the reason has to do with the difference between self-reporting on a sexual problem vs applying diagnostic criteria that are more rigorous, albeit vague. Self-report estimates range between 20% and 33%; it is not clear as to whether the majority of these men would qualify for a diagnosis of rapid ejaculation. Moreover, there are problems in the criteria used to diagnose men with rapid ejaculation. If we look at the diagnostic criteria, we see that they're extremely vague. The DSM-IV guideline defines PE as ejaculation before, shortly after, or before they wish. Ejaculating before penetrating the vagina, termed anteportal ejaculation, is very rare. The vagueness in the terminology, "shortly after" or "before the person wishes," I think creates confusion. You and I and 5 other physicians may disagree on the meaning of "shortly after" or "before the person wishes." We have no clear operational definition of the dysfunction. Some clinical trials have adopted a definition of PE as ejaculation after a fixed amount of time after penetration. But if you look at all the studies through the 1990s, there's a great deal of variability in the time used as a diagnostic criterion, ranging from 1 minute -- Dr. Waldinger's[1] definition -- to up to 7 minutes.
The bigger issue, however, is that no matter how you define PE, there's a large population out there, but all of us -- and you've heard this today -- don't see very many people coming to our offices for treatment. This has always been the intriguing thing for us: That even since the mid-90s when we had the off-label uses of medications for PE -- and then of course there's always been the psychotherapy -- we just don't see the numbers of patients that are congruent with the high prevalence estimates.
Medscape: There seems to be a move toward defining PE using objective measures. Do you think that it will ever be possible to come up with a definition of PE that is entirely objective?
Dr. Althof: Obviously, I think we can do better in terms of diagnostic criterion. The FDA is focusing on the intravaginal ejaculatory latency time (IELT) as the primary endpoint in clinical trials. But in terms of treating patients, you need to look beyond genital function. You can't be so narrow as to look at just ejaculatory latency and control; you need to look at the bigger picture -- the larger psychological impact on the man and partner. What I mean is, you will be of help to people by increasing latency, but you've got to go beyond that. I'm a big advocate for not being narrow, not being genitally focused.
Medscape: That leads to my next question. Is there a straightforward correlation between latency time and sexual satisfaction? Have studies shown that the longer the latency, the greater the satisfaction?
Dr. Althof: Satisfaction is a difficult concept; it's what you call a 1-item multiple-concept idea. When you start asking about satisfaction, you realize that it involves a lot of factors. What is it that you're really asking the person when you ask him if he's satisfied? Is it simply the physical sensations that are satisfying? Is it his partner's satisfaction that makes him feel satisfied? Is it the sense of masculinity, the sense of accomplishment that he gets from doing what he thought he should do? It could be any or all of these things. Men with PE have diminished satisfaction, as do their partners. However, this is not likely to be a linear correlation. As latency increases other factors may make an encounter more or less satisfying. We haven't really developed a clear outcome measure for it. We're very focused on time and control, but the subjective aspects are indeed what's important. As I have said before; I think that PE is a little bit more like female sexuality in that we have to look at the subjective aspects and recognize their importance. Erectile dysfunction, on the other hand, is a much more objective phenomenon to assess.
Medscape: Before talking about the new treatment options presented today, what are the options that patients and their doctors have had in the past?
Dr. Althof: Let me say that as a psychologist, for years and years we've had psychological interventions. And when these are discussed now, they usually get reduced to 2 things: the squeeze technique and the stop-start technique. I think this is misleading. We have of course used these behavioral exercises, but psychotherapy or sex therapy is much more than that. And remember, you've got to be thinking about the man, the partner, and their lovemaking in context. You can't just say to a patient, "Here try this exercise (eg, squeeze technique)." You've got to get a sense of what's really going on in the man and woman and their relationship. How do the issues in the man's or woman's life contribute to what's going on? Does she have little sexual desire? If so, maybe she's happy with the man ejaculating quickly. So there are all these variables to consider. I think that sex therapy isn't well understood or sufficiently utilized.
But to get to your question about the efficacy of earlier treatments, when you look at outcome studies, for example Masters and Johnson, they reported 99% success rate. Actually, what they reported was a 1% failure rate, but that has always been taken to imply a 99% success rate. Nobody ever has had as large a sample as Masters and Johnson, and nobody else has reported on a 5-year outcome that I know of. But other reports, and of nicely done studies, give success rates more in the two-thirds area initially. Psychotherapy gets clobbered because 3 years later success rates dwindle to 25% -- that's true; but to counter this phenomenon, the field has incorporated the concept of relapse prevention. Rather than saying goodbye to couples after they are doing better, I will always say to them, "I'll see you in 3 months" just for a short follow-up. It's not my idea, it's actually Barry McCarthy's[2] idea, and relapse prevention sessions sustain the initial success rates.
For other treatments, we've had numbing creams like lidocaine and prilocaine -- anesthetic ointments. These have their own set of problems as you can imagine. You need to use a condom or thoroughly wipe off the cream. Moreover, you're making love with a penis that's less sensitive, so there's less pleasure. Then there's always the worry of transvaginal absorption, leading to the partner's loss of sensation.
Other forms of treatment include the off-label use of SSRIs (selective serotonin reuptake inhibitors), which, as you know, we discovered when we were treating depression and would have men and women coming in to report that the drug was making it more difficult to reach orgasm. We began to experiment with SSRIs -- paroxetine, sertraline, and fluoxetine. And that approach works; the problem is that the patients require chronic (daily) dosing to get the best results. However they don't like daily dosing for an event that occurs maybe once or twice a week. So patients tended to have a high discontinuation rate, not because of adverse events, but because they figure, "Why am I taking a pill every day for this?" When we gave them the pill on an as-needed basis, patients didn't do as well as they did on a chronic basis.
Medscape: I was interested to hear in a presentation today that European patients, as opposed to American patients, seem to prefer chronic dosing.
Dr. Althof: Yes, I didn't know that, actually. But I think patients are also resistant to taking a psychiatric medication, an antidepressant. You know of course how Wellbutrin became Zyban to stop smoking, and Prozac became Sarafem for premenstrual syndrome. Patients don't like knowing that they're taking a psychiatric medication so there's a lot of resistance to taking these drugs. The main issue is that men want to be able to do it on their own; they want to have self-efficacy and so they want at some point to do it by themselves without the medication. So I think the ideal treatment is really probably restoring their confidence with a medication and then putting in some behavioral treatment to help these men learn to control it on their own. There are probably some men who will never be able to do that; on the other hand, I think there may be a large cohort of men that will do better -- maybe not as well as with medication -- but it'll be good enough for them and good enough for their partners. And now you have the drugs that are being developed not for depression but for the indication of rapid ejaculation. They are designed to be taken on an as-needed basis, such as dapoxetine and a drug that Pfizer has under study, and so I think we'll be seeing at least 2 drugs over the next several years.
Medscape: How would you evaluate the importance of the phase 2 trial results of the dapoxetine trial that were presented today?
Dr Althof: Well, I think it's encouraging that we have a drug to be taken on an as-needed basis that shows a significant impact on ejaculatory latency. What I think remains to be seen is what the FDA refers to as minimally important differences. Will these drugs demonstrate enough change? Statistically speaking, there certainly is significant change, but is it enough change for either the regulatory agency or for the man? I think that's the question that remains to be answered. However, I think the drug shows great promise.
Medscape: One thing that wasn't addressed in the presentation was the partner's reaction to this treatment. Were the partners asked about their sexual satisfaction following the treatment?
Dr. Althof: I don't know the data on the women's response, but that's a very important question. In a lot of the clinical trials, it's very difficult to get the women to come in and participate and then to complete the protocols. That's an important part of the story. What people get confused about is that the problem for the partner is simply bad (quick) sex. What really happens is that when a man and a woman have this problem of rapid ejaculation, all of the intimacy suddenly comes to an abrupt end. The man is angry, ashamed, upset, and frustrated, and turns away from his partner. The woman is equally upset with his rapid emotional distancing. So it's not just that the sex may not be good, it's the disruption, the abrupt disruption in intimacy that is the most troubling thing for the women I speak to. So in some ways, the question is: Can you teach men not to have this response to rapid ejaculation? I think we have yet to see that part of the story being told.
