Botox: A Treatment for Premature Ejaculation?

Experts suggest its effectiveness, but FDA has yet to approve

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During the past 30 years, the treatment of premature ejaculation has expanded from psychotherapy to include medications and pharmacotherapy. It may come as a surprise that Botox, which is a toxin produced by the bacterium Clostridium botulinum and commonly used to smooth facial wrinkles, may help with premature ejaculation. However, much of the research is presented as a hypothesis, and the use of Botox for premature ejaculation has not yet been approved by the FDA.

Defining Premature Ejaculation

The treatment of premature ejaculation depends on how this condition is defined.

Broadly, premature ejaculation is split into two categories: lifelong or acquired.

Lifelong premature ejaculation begins with the first sexual experience. Ejaculation occurs quickly—either before penetration or within one or two minutes of penetration.

Acquired premature ejaculation can manifest either suddenly or gradually following a history of normal ejaculation. Furthermore, this condition may be rooted in urological, thyroid, or psychological issues.

Over the years, the definition of premature ejaculation has evolved. The starting point for most studies of premature ejaculation is the following definition from the DSM-IV-TR:

  • The persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the person wishes it. The clinician must take into account the factors that affect the duration of the excitement phase, such as age, novelty of the sexual partner or situation and recent frequency of sexual activity
  • The disturbance causes marked distress or interpersonal difficulty 
  • PE is not exclusively a result of the direct effects of a substance (eg withdrawal from opioids).

In 2014, the International Society for Sexual Medicine provided the following evidence-based definition for lifelong premature ejaculation.

  • A male sexual dysfunction characterized by ejaculation that always or nearly always occurs prior to, or within about one minute, of vaginal penetration
  • The inability to delay ejaculation on all, or nearly all, vaginal penetrations
  • Negative personal consequences such as distress, bother, frustration, and/or the avoidance of sexual intimacy.

In 80 percent of men with lifelong premature ejaculation, ejaculation occurs within 30 to 60 seconds of a sexual encounter. The remaining 20 percent of these men experience an ejaculation that lasts between one and two minutes.

Premature ejaculation is estimated to affect between 30 percent and 70 percent of American men. According to the results of the National Health and Social Life Survey, the prevalence of premature ejaculation in the United States is 30 percent and affects men of all ages. Premature ejaculation is most common in young men aged between 18 and 30. Premature ejaculation also affects men with secondary impotence who are aged between 45 and 60 years.

Of note, some men occasionally experience premature ejaculation, and this may not be concerning. Furthermore, although formal definitions of premature ejaculation describe it as happening with nearly every sexual encounter, if it occurs between 10 percent and 20 percent of the time that sex is attempted, then treatment may be warranted.  

Treating Premature Ejaculation With Botox

Botox injections function by weakening or paralyzing muscles as well as blocking nerves. The effects of Botox last between three and twelve months. Common adverse effects of Botox include swelling, bruising, and pain at the injection site.

In addition to smoothing facial wrinkles, here are some other uses of Botox:

  • Profuse underarm sweating (i.e., hyperhidrosis)
  • Crossed eyes (i.e., strabismus)
  • Chronic migraines
  • Uncontrolled blinking (i.e., blepharospasm)
  • Overactive bladder

The bulbospongiosus and ischiocavernosus muscles are part of penile shaft, and these muscles are most important in ejaculation. During ejaculation, these muscles experience stereotyped rhythmic contractions.

Botox selectively blocks the release of acetylcholine from nerve endings, and it’s hypothesized that this mechanism may inhibit the stereotyped rhythmic contractions of the bulbospongiosus and ischiocavernosus and thus help delay ejaculation.

There have been some concerns voiced about the use of Botox to treat premature ejaculation. First, some experts worry that Botox will block ejaculation completely and result in anejaculation. There have also been concerns about the cost-effectiveness of using Botox to treat premature ejaculation.

In a patent filed by Allergan in 2012, different approaches to Botox administration for the treatment of premature ejaculation are suggested, including the following:

"A method for treating premature ejaculation in a patient in need thereof is provided, where the method comprises a step of locally administering, by injection, a botulinum neurotoxin to a penis of the patient, thereby treating premature ejaculation in the patient. In particular embodiments, the botulinum neurotoxin is injected into at least two penile locations, and in some examples at least three penile locations."

The authors of the patent suggest that Botox could be injected into the glans or frenulum of the penis (near the tip of the penis). Furthermore, Botox could be used on an as-needed basis, with the effects lasting up to six months. The intervention should start working within 48 to 72 hours, and there should be no or limited adverse effects.

Much of the research published regarding the use of Botox is presented as hypotheses and prognostication. Apparently, Botox should work to treat premature ejaculation but more research needs to be performed to ensure efficacy. On August 15, 2017, Allergan terminated phase 2 clinical trials examining the use of Botox to treat premature ejaculation, but results from this study are unavailable.

Other Treatments for Premature Ejaculation

Although no FDA-approved treatment for premature ejaculation exists, other interventions have been used to treat this condition.

Selective serotonin-reuptake inhibitors (SSRIs) and tricyclic antidepressants have proven quite effective in the treatment of premature ejaculation. Specifically, paroxetine, sertraline, fluoxetine, citalopram, and clomipramine have all been used to treat premature ejaculation. The use of these medications for the treatment of premature ejaculation is off-label.

These medications can be taken every day or as needed. Although long-term treatment with antidepressant medications is more effective than as-needed usage, long-term administration causes more adverse effects. With continuous administration, the SSRI is most effective after it reaches steady state, which can take weeks. However, benefit can occur earlier.

One SSRI that is particularly suited for the treatment of premature ejaculation is dapoxetine (Priligy). This short-acting SSRI was developed specifically to treatment of premature ejaculation and can be used as-needed. Dapoxetine can be taken a few hours before sexual activity.

Another approach that can help prevent premature ejaculation involves the use of topical anesthetics to decrease sensation in the penis and thus impede ejaculation. In addition to anesthesia, a condom can be used to further decrease sensation. Topical anesthetics used for this purpose are lidocaine and prilocaine.

Finally, a small number of men with premature ejaculation may benefit from performing pelvic floor or Kegel exercises.

What About Behavioral Therapy?

Currently, most experts hypothesize that premature ejaculation is a neurobiological and genetic condition. Consequently, long-term behavioral therapy is considered ineffective for lifelong premature ejaculation. Furthermore, long-term studies have shown that behavioral therapy is ineffective in treating lifelong premature ejaculation.

In a 2014 article titled “Premature ejaculation: definition, epidemiology, and treatment,” Kirby writes the following regarding behavioral and psychological therapies for premature ejaculation: "Therapies have been incorporated for a number of years, but quantitative research shows benefit is not forthcoming. Nevertheless, many patients are understandably anxious and may appreciate psychotherapy."

For acquired premature ejaculation, a combination approach to treatment could work. This approach involves the stop-start technique, cognitive behavioral therapy, and drugs. With the start-stop method, a man recognizes mid-level excitement during intercourse and stops intercourse for about a minute. Once the man has regained control, intercourse is resumed. Alternatively, with the squeeze method, the man squeezes the penis before ejaculation to reduce the erection and stop ejaculation.

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