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New and Experimental Treatments for Erectile Dysfunction

New and Experimental Treatments for Erectile Dysfunction – 2023

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By on - Updated February 14, 2023 ED Treatments
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Currently available treatments for erectile dysfunction are essentially unchanged for 20 years, and overall, men are not satisfied with their options.  Furthermore, none of the currently available medical treatments offers a cure for ED…  they simply treat the symptoms.

But there are several new treatments under development which could greatly improve ED treatment, and in some cases offer a permanent cure.

The treatments described below are experimental.  That means several things:

  1. There is not enough clinical evidence to prove that the treatment actually works.
  2. Because the treatment is new and still being tested, the optimum protocol (treatment plan) is still being figured out.
  3. There may be side effects or health risks, some of which may not be known.
  4. It may be difficult to find a doctor who is qualified and willing to provide the treatment.
  5. Treatments may be expensive, and in most cases are not covered by insurance.

In a strongly-worded statement in March, 2018, the Sexual Medicine Society of North America (SMSNA) recommended that “the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval. Patients considering such therapies should be fully informed and consented regarding the potential benefits and risks. Finally, the SMSNA advocates that patients involved in these clinical trials should not incur more than basic research costs for their participation1.”

If these new treatments prove safe and effective, they may become mainstream in a few years.  Until then, patients should only consider these treatments if they are offered by a licensed medical doctor, and preferable as part of a sponsored clinical study.

New Therapies

New and experimental treatments for erectile dysfunction include:

Botulinum Neurotoxin (Botox®)

Several small studies2 3 4 have found that intra-cavernous injection of botulinum toxin (Botox®, Dysport®) can improve the effectiveness of PDE5 inhibitors among men who were previously unresponsive. The injections work by relaxing blood vessels in the penis, increasing blood flow. (See our article “How Do Erections Work?”) A single injection is effective for 3-6 months.

Electrical Stimulation of the Pelvic Floor Muscles

Kegel exercises, which strengthen the pelvic floor muscles, have long been used as a treatment for incontinence and erectile dysfunction5. A 2020 study of women found that electrical stimulation strengthened pelvic floor muscles6, and electrical stimulation is employed by physical therapists to strengthen pelvic floor muscles in men following prostate surgery.

A home device for electrical stimulation of pelvic floor muscles in men, the eKegel, was released in 2021.

Functional Electrical Stimulation (FES)

A small clinical trial has shown that Functional Electrical Stimulation (FES) could be an effective treatment for erectile dysfunction7. In the trial, electrical stimulation was administered twice a week, over a period of four weeks. At the conclusion of the treatment, patients showed a statistically significant improvement in erectile function; a control group who received a placebo treatment did not show improvement.

Based on this trial, FES has potential as a treatment for ED. However, additional, larger-scale studies are needed. This treatment is currently not available commercially.

FES should not be confused with Transcutaneous Electrical Nerve Stimulation (TENS).

FES is the use of electrical stimulation to produce contractions in weak or paralyzed muscles. This contraction is combined with a functional activity where the targeted muscle is typically activated. In other words, just placing electrical stimulation on a muscle is not FES. The goal of FES is to pair electrical stimulation with activity and the person’s volition in order to promote nervous system repair and recovery.

TENS, on the other hand, is intended for temporary pain relief in sore and aching muscles or for symptomatic relief of chronic pain.

The FDA has approved TENS devices for sale in the United States. However, there is no evidence that these devices are effective in treating erectile dysfunction.

Gene Therapy

The potential for gene therapy is exciting, because it could be used to address several factors that contribute to ED, including nitric oxide levels, and regenerating smooth muscles, blood vessels and nerves.  (See our article “How Do Erections Work?“)

Clinical studies are still in early phases (demonstrating the safety of the treatment, before larger trials evaluate its effectiveness).  An early safety study showed significant improvement for several patients8 .

Light Therapy / Red Light Therapy

Proponents of light therapy claim that regular exposure to bright light – either full-body or specifically in the area of the genitals – is an effective treatment for sexual dysfunction.  Many of the claims focus on specific wavelengths of light (“red light”).

Numerous studies9 10 have found that bright light therapy is an effective treatment for depression (both seasonal and non-seasonal).  For patients whose ED is caused primarily by depression, light therapy can be an effective treatment option.  (See our article, “Do You Suffer from Depression?“)

Bright light therapy for the treatment of depression should be administered by a qualified medical professional as part of an overall treatment program.

Additional claims about light therapy and the treatment of ED seem to stem from one widely-quoted study11, which found that light therapy significantly increased the subjective feelings of sexual satisfaction, and raised testosterone levels.  A 2013 study12 found that red-light therapy increased serum testosterone levels in rats.

Based on these and other studies, it appears that light therapy may be an effective treatment for men with low levels of testosterone; further human studies are needed to confirm these results.

Melanocortin Receptor Agonists

Drugs such as Bremelanotide (PT-141), which act on receptors in the brain, can increase feelings of sexual arousal in both men and women.  Limited studies have shown positive results for men suffering from diabetic ED and psychological ED13. The drugs are not an effective treatment for ED due to vascular problems.

Patients experienced significant side-effects, including nausea and hypertension (increased blood pressure).

The drug was approved by the FDA on June 21, 2019, for treating female sexual dysfunction, but is not currently approved as an ED treatment.

Platelet-Rich Plasma (PRP) Injection Therapy

PRP therapy uses the patient’s own blood to treat ED.  Blood is drawn from the patient and placed in a centrifuge to remove the plasma, and concentrate platelets and growth factors.  The concentrated blood is then injected into the penis in order to promote the development and growth of blood vessels and nerves.

PRP injections have been used for many years to promote healing in wounds and injuries.  Treatment usually consists of one or more injections.  There have been hundreds of clinical studies for PRP injections; most show little if any effect.

The therapy is now being extensively promoted as a treatment for ED.  There are even claims that PRP injections can increase penis size.  Neither claim is supported by clinical studies14 so far.

A review of the current research15, conducted in 2019, concluded that “Despite a global presence of PRP clinics and ongoing active marketing and public interest in regenerative medicine, no scientific evidence has been published to establish an evidence-based risk-benefit profile for PRP use for ED in humans.”

Another research review, conducted in 202216, concluded that “PRP injections for the treatment of ED may be promising, but no recommendation can be made because of scarce evidence. Safety and effectiveness of this therapy in the treatment of ED and PD require further preclinical and clinical studies with standardized protocols to gain an adequate insight into its potential implications.”

In short, ongoing research has not demonstrated the effectiveness of PRP therapy.  This probably means that, if there is any benefit at all, it is small.

Priapus Shot® and P-Shot®

Priapus Shot® and P-Shot® are registered service marks of Studio Medicine, and refer to their proprietary procedures.  These procedures include PRP injections, combined with other forms of treatment such as vacuum pumps.  It is claimed that these procedures can help correct ED, and also increase the size of the penis.

We’ve been unable to locate any independent clinical trials to support these claims.  Dr. Sheldon Marks, writing on the WebMD website17, states “there is no evidence to show it is scientifically proven to work as claimed and it has not been thoroughly tested for safety. Additionally, at a cost of several thousand dollars per shot, it’s an expensive gamble. Unless new research comes to light, I won’t be recommending this treatment to my patients.”

Note that Dr. Charles Runels, inventor of the P-Shot, was issued a “Notice of Initiation of Disqualification Proceeding” by the FDA in 2008, and was disqualified from conducting clinical studies in 2009.  Getting disqualified by the FDA means a clinical investigator has “repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA, in any required report.”

Shockwave Therapy (LI-ESWT)

Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT), commonly called shockwave therapy, is used to treat ED caused by vascular problems.

As of June, 2020, we’ve moved this section from the Experimental Treatments page.  We believe that there is sufficient clinical evidence to consider LI-ESWT to be a mainstream treatment for erectile dysfunction.

Please see our article on “Shockwave Therapy (LI-ESWT) for Erectile Dysfunction“.

Spider Venom

The bite of the Brazilian Wandering Spider (Phoneutria nigriventer) has been found to cause erections. Scientists are now testing the PnTx2-6 protein, which has been isolated from the toxin, in order to produce an oral medication. Several positive studies have been conducted with rats18 19; human trials have not yet been conducted.

Current oral medications for erectile dysfunction inhibit the effect of the PDE5 enzyme, which allows blood to flow out of the penis. The spider venom works on a different principle; it increases the production of Nitric Oxide (NO), which causes blood to flow into the penis. (See our article “How Do Erections Work?“)

PnTx2-6 may be effective for men who don’t respond to current medications, or who experience severe side effects from PDE5 inhibitors.

Stem Cell Therapy

Stem Cell therapy uses the patient’s own stem cells to treat ED.  Typically, fat cells are taken from the patient’s stomach; stem cells are extracted and injected into the penis in order to promote the development and growth of blood vessels and nerves.  The process is very similar to PRP injections, but the two treatments should not be confused.

Stem cell treatments have been tested extensively in rats, and more recently in small human trials20.  The results have been promising.  In a study involving men who had been through prostate removal, more than half recovered erectile function sufficient for penetrative sex21.

Other early-stage studies have also shown positive results22  23.

Note that the US FDA warns against unapproved or unregulated stem cell treatments.

Potential hazard associated with stem cell therapy include:

  • Administration site reactions,
  • The ability of cells to move from placement sites and change into inappropriate cell types or multiply,
  • Failure of cells to work as expected, and
  • The growth of tumors.

Thermal Activated Penile Implant

Current penile implants are complicated to install, and prone to mechanical failure.  Researchers are experimenting with a new metal alloy that “remembers” a shape, and returns to that shape when heated by electrical induction24.

In theory, a user could cause the penis to become erect by passing an electrical induction device over it, causing the metal implant to stiffen.  The implant surgery would be much simpler, and the device would be more reliable, than current implants.

The device is currently undergoing mechanical testing; human trials will not begin for several years.

Topical Ointment (alprostadil)

Topical ointments or gels are applied directly to the penis 30-60 minutes prior to intercourse.  One gel, Topiglan (1% alprostadil, an ingredient commonly used in penile injections and suppositories), was effective in approximately 40% of the men tested25.

Newer formulations, sold under several brand names, including Vitaros® and Virirec®, appear to be effective for more than 60% of men.  Although they are available in much of the world, these ointments have not yet been approved by the FDA for sale in the United States.

Clinical trials have found alprostadil to be a safe and effective alternative to oral medications for ED26 27.

Topical Ointment (glycerol trinitrate)

Another type of topical ointment uses glycerol trinitrate, which, when absorbed through the skin of the penis, increases the supply of nitric oxide. Nitric oxide relaxes the smooth muscles in the penis, allowing blood vessels to expand and increasing blood flow.  In a Phase II clinical trial, it improved the ability to achieve an erection for about 25% of the test subjects28.  The test used the lowest effective dose of the drug; future tested will use higher concentrations to see if more men show improvement.

Topical Ointment (nitroglycerine)

A third type of topical agent, nitroglycerin, relaxes blood vessels; it is commonly taken orally for heart attacks.  Like glycerol trinitrate, it has been shown to be effective in clinical testing29, especially for men with mild to moderate ED.

It is not approved by the FDA for use in the United States.

For More Information

Causes of Erectile Dysfunction

Treatments for Erectile Dysfunction



References

  1. SMSNA.  “Position Statement:ED Restorative (Regenerative) Therapies.” Sexual Medicine Society of North America. <http://www.smsna.org/V1/images/SMSNA_Position_Statement_RE_Restorative_Therapies.pdf>
  2. El-Shaer, Waleed; Ghanem,Hussein; Diab, Tamer; Abo-Taleb, Ahmed; Kandeel, Wael. “Intra-cavernous injection of BOTOX® (50 and 100 Units) for treatment of vasculogenic erectile dysfunction: Randomized controlled trial.” Andrology. March 2021.
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  3. Giuliano, Francois; Joussain, Charles; Denys, Pierre. “Long Term Effectiveness and Safety of Intracavernosal Botulinum Toxin A as an Add-on Therapy to Phosphosdiesterase Type 5 Inhibitors or Prostaglandin E1 Injections for Erectile Dysfunction.” Journal of Sexual Medicine. January 2022; 19(1):83-89.
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  4. Ghanem, Hussein; Abdel-Raheem, Amr; Abdel-Rahman, Islam Fathy Soliman ; Johnson, Mark; Abdel-Raheem, Tarek. “Botulinum Neurotoxin and Its Potential Role in the Treatment of Erectile Dysfunction.” Sexual Medicine Reviews. January 2018; Volume 6, Issue 1.
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  13. Ryu, Ji-Kan; Suh, Jun-Kyu; Burnett, Arthur L. “Research in pharmacotherapy for erectile dysfunction.” Translational Andrology and Urology. Ap 2017; 6(2): 207–215.
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  14. Wu, Chien‐Chih; Wu, Yi‐No; Ho, Hsiu‐O; Chen, Kuo‐Chiang; Sheu, Ming‐Thau; Chiang, Han‐Sun. “The Neuroprotective Effect of Platelet‐rich Plasma on Erectile Function in Bilateral Cavernous Nerve Injury Rat Model.” The Journal of Sexual Medicine. Nov 2012. Volume 9, Issue 11, Pages 2838–2848.
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  17. Marks, Sheldon.  “Can PRP Injections Really Give You a Bigger Penis?”  WebMD Men’s Health.  Jun, 2016.
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  21. Haahr, Martha Kirstine; Jensen, Charlotte Harken; Toyserkani, Navid Mohamadpour; Andersen, Ditte Caroline; Damkier, Per; Sørensen, Jens Ahm; Lund, Lars; Sheikhb, Søren Paludan. “Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial.” EBioMedicine. Mar 2016. 5: 204–210.
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