New and Experimental Treatments for Erectile Dysfunction – 2018

0

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 methodology is still unknown.
  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.

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.

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 patients1 .

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 studies2 so far.

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 website3, 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.”

Shockwave Therapy (LI-ESWT)

Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT), commonly called shockwave therapy, is used to treat ED caused by vascular problems.  Administering low-intensity sound waves has been found to encourage the development of new blood vessels, and improve the function of smooth muscle and endothelial cells.

A portable device is coated with a lubricating gel and applied directly to the penis.  The procedure is painless.  Sessions may last from 10 to 30 minutes.  Treatment requires several sessions per week, over a period of 6-12 weeks.  A follow-up treatment may be scheduled 6 months later.

There are several studies that show promising results4 5 6 7, especially for men with mild to moderate ED (caused by vascular problems).  However, a review of previous work8, conducted in 2017, found contradictory results, with some studies showing promise, some providing inconclusive findings and some even discouraging.

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 rats9 10 11; 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 trials12.  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 sex13.

Other early-stage studies have also shown positive results14  15.

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 induction16.

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

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 tested17.

Topical agents could be used in conjunction with oral medications (PDE5 inhibitors) to enhance erections.

Topiglan has completed a Phase 3 clinical trial.  However, the manufacturer has found that the gel loses potency in storage; a further trial is planned with a redesigned applicator.


For More Information

Causes of Erectile Dysfunction

Treatments for Erectile Dysfunction


References

  1. Melman, Arnold; Bar-Chama, Natan; McCullough, Andrew; Davies, Kelvin; Christ, George. “hMaxi-K Gene Transfer in Males with Erectile Dysfunction: Results of the First Human Trial.” Human Gene Therapy. Dec 2006. Vol. 17, No. 12.
    <https://www.ncbi.nlm.nih.gov/pubmed/17134370>
  2. 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.
    <https://www.ncbi.nlm.nih.gov/pubmed/22906160>
  3. Marks, Sheldon.  “Can PRP Injections Really Give You a Bigger Penis?”  WebMD Men’s Health.  Jun, 2016.
    <https://blogs.webmd.com/mens-health-office/2016/06/can-prp-injections-really-give-you-a-bigger-penis.html>
  4. Kalyvianakis, D; Memmos, E; Mykoniatis, I; Kapoteli, P; Memmos, D; Hatzichristou, D. “Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment.” Journal of Sexual Medicine. Mar 2018. 15(3):334-345.
    <https://www.ncbi.nlm.nih.gov/pubmed/29396020>
  5. Srini, Vasan Satya; Reddy, Rahul Kumar; Shultz, Tamar; Denes, Bela. “Low intensity extracorporeal shockwave therapy for erectile dysfunction: a study in an Indian population.” The Canadian Journal of Urology. Feb 2015. 22(1).
    <https://gainswave.com/wp-content/uploads/2016/11/Canadian-Journal-of-Urology-Srini.pdf>
  6. Fojecki, GL; Tiessen, S; Osther P.J. “Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study.” Sexual Medicine. Mar 2018. 6(1):1-7.
    <https://www.ncbi.nlm.nih.gov/pubmed/29275957>
  7. Lu, Z; Lin, G; Reed-Maldonado, A; Wang, C; Lee, Y.C.; Lue, T.F. “Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis.” European Urology. Feb 2017. 71(2):223-233.
    <https://www.ncbi.nlm.nih.gov/pubmed/27321373>
  8. Fode, Mikkel; Lowenstein, Lior; Reisman, Yacov. “Low-Intensity Extracorporeal Shockwave Therapy in Sexual Medicine: A Questionnaire-Based Assessment of Knowledge, Clinical Practice Patterns, and Attitudes in Sexual Medicine Practitioners.” The Journal of Sexual Medicine. Jun 2017. 5(2): e94–e98.
    <https://www.ncbi.nlm.nih.gov/pubmed/28268167>
  9. Dorey, G; Siegel, A; Nelson, P. “The Effect of a Pelvic Floor Muscle Training Program Using Active and Resisted Exercises on Male Sexual Function: A Randomised Controlled Trial.” 2015.
    <https://www.semanticscholar.org/paper/The-Effect-of-a-Pelvic-Floor-Muscle-Training-Using-Ga/de9b6634ce40eda684107c5be537d73c3ee116c6>
  10. Jung, A R; Choi, Y S; Piao, S; Park, Y H; Shrestha, K R; Jeon, S H; Hong, S H; Kim, S W; Hwang, T K; Kim K H; Lee J Y. “The effect of PnTx2-6 protein from Phoneutria nigriventer spider toxin on improvement of erectile dysfunction in a rat model of cavernous nerve injury.” Urology. Sep 2014, 84(3):730.e9-17. doi: 10.1016/j.urology.2014.05.030.
    <https://www.ncbi.nlm.nih.gov/pubmed/25168567>
  11. Nunes, K P; Toque, H A; Borges, M H; Richardson, M; Webb, R C; de Lima, M E. “Erectile function is improved in aged rats by PnTx2-6, a toxin from Phoneutria nigriventer spider venom.” Journal of Sexual Medicine. Oct 2012, 9(10):2574-81. doi: 10.1111/j.1743-6109.2012.02878.x. Epub 2012 Aug 23.
    <https://www.ncbi.nlm.nih.gov/pubmed/22925420>
  12. Lin, Ching-Shwun; Xin, Zhong-Cheng; Wang, Zhong; Deng, Chunhua; Huang, Yun-Ching; Lin, Guiting; Lue, Tom F. “Stem Cell Therapy for Erectile Dysfunction: A Critical Review.” Stem Cells and Development. Feb 2012. 10; 21(3): 343–351. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272247/>
  13. 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.
    <https://www.ebiomedicine.com/article/S2352-3964(16)30020-2/fulltext>
  14. Reed-Maldonado, Amanda B; Lue, Tom F. “The Current Status of Stem-Cell Therapy in Erectile Dysfunction: A Review.” World Journal of Men’s Health. Dec 2016. 34(3): 155-164.
    <https://wjmh.org/Synapse/Data/PDFData/2074WJMH/wjmh-34-155.pdf>
  15. Soebadi, MA; Moris, L; Castiglione, F; Weyne, E; Albersen M. “Advances in stem cell research for the treatment of male sexual dysfunctions.” Current Opinion in Urology. Mar 2016. 26(2):129-39.
    <https://www.ncbi.nlm.nih.gov/pubmed/26759972>
  16. Le, B; McVary, K; McKenna, K; Colombo, A. “A Novel Thermal-activated Shape Memory Penile Prosthesis: Comparative Mechanical Testing.” Urology. Jan 2017. 99:136-141.
    <https://www.ncbi.nlm.nih.gov/pubmed/27639798>
  17. Goldstein, I; Payton, T.R.; Schechter, P.J. “A double-blind, placebo-controlled, efficacy and safety study of topical gel formulation of 1% alprostadil (Topiglan) for the in-office treatment of erectile dysfunction.” Urology. Feb 2001. 57(2):301-5.
    <https://www.ncbi.nlm.nih.gov/pubmed/11182341>

Comments are closed.