Priapus Shot® Procedure
The Priapus Shot® procedure indicates a specific way of treating the penis with blood-derived growth factors extracted from the man’s own blood (autologous). Some people call these blood-derived growth factors platelet-rich plasma (PRP) but there may be growth factors in plasma we don’t yet know about that do not come from the platelets. The name “Priapus Shot®” is registered with the US Patent & Trademark office as a “service mark” to protect patients by indicating a specific protocol. The name is not a synonym for the injection of blood in to the penis—such a definition would not be specific enough to indicate any particular quality of care. and so would not warrant protection as intellectual property.
The trademark defines a specific method of that providers agree to follow and develop; this agreement offers quality control and is followed and developed by over 500 urologists, interventional radiologists, family practitioners, and internists in multiple countries and by faculty in medical schools where further studies are being done.
The Priapus Shot® procedure protocol also involves patient selection, patient evaluation & education (including explanation of consent), preparation of the PRP, local anesthesia, PRP injection, post injection use of a penis pump on a daily basis, and a daily dose of tadalafil (in come men). Other post injection steps can include: stopping smoking, CoQ10 (12), vitamin E (13), Trimix, and aerobic exercise. Protocol steps vary depending on the patient and those variations also comprise the Priapus Shot® protocol.
Patient selection includes identifying those who may need hormonal treatment, or family counseling, or vascular surgery, as well as those who may have co-morbidities or who may be taking drugs that interfere with sexual function. Some patients are not treated with the Priapus Shot® protocol because another treatment or no treatment is more appropriate.
The policy of most of our providers of the procedure offers a complete refund to any man who is not happy with the Priapus Shot® procedure.
Consulting with the patient includes informing him that unexpected side effects could occur and the results will vary with some patients seeing no benefit. Antibiotics fail in 1 in 5 people in the hospital with pneumonia—resulting in death. Antibiotics “work” but do not work for all people. The same can be said for most all procedures including the Priapus Shot procedure.
The preparation of the PRP involves a device approved by the FDA for isolating PRP from whole blood for autologous use. Since blood is not a drug, it is not governed by the FDA but the devices used to isolate PRP for injection back into the body are regulated by the FDA. Multiple kits have gained FDA approval. Some of the approved kits include Regen, Magellan, TruPRP, Eclipse, Pure Spin, Harvest, & Emcyte. There are over 8,000 research papers on pub med discussing the science of PRP, and not one serious side effect has been documented when FDA approved kits were used to prepare the PRP.
Most men find the procedure very comfortable if a topical lidocaine cream is applied to the penis about 15 minutes prior to the procedure. A very small needle (1/2 inches long, 30 gauge) needle is used for the injection. However, some men do ask for a dorsal nerve block which can easily be done using 2% lidocaine for a near painless procedure (this same block can be used for prosthesis placement—so it makes a 30 gauge needle completely painless for most men.
The Science
An early report that PRP may be useful in the penis appeared in a paper published in Urology in 2003 mentioning that, in animal models, using blood-derived growth factors injected into the penis successfully treated erectile dysfunction and also mentioned that such a strategy may be feasible in men— actually providing a way to correct the underlying pathology (1). In contrast, Viagra and Trimix do not correct the underlying pathology of decreased penile circulation.
Another animal study in 2010 showed that transferring adipocyte derived stem cells (ADSCs) into the penis caused endothelia cell growth (new blood flow) as well as increased nitric oxide activity in the dorsal nerve (harder erection). But, the ADSCs were tagged before injection (to keep up with them) and most of the injected stem cells died! So the improvement seen was not from maturation of the ADSCs but rather from recruitment and activation by growth factors of stem cells already in the body—indicating PRP may demonstrate a similar effect (2).
Dr. Virag (also a pioneer of Trimix injections) published research demonstrating improvement in erectile function, size, and correction of Peyronie’s disease with the use of PRP. His studies both published (and to be published) demonstrate a mean increase of 7 on the ED Intensity Score when PRP is injected into the plaque and into the corpus cavernosum of the human penis (3).
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One of the growth factors found in PRP (over 20 known) includes vascular endothelial growth factor (VEGF). In one animal study, the animals were castrated causing a shutting off of testosterone to create a penis that demonstrated, on microscopy, atrophy of smooth muscle and nerves as well as endothelial cell pathology. Then another group received VEGF injections directly into the corpus cavernosum along with castration. VEGF injection into the penis at the time of castration prevented the atrophy as effectively as did testosterone replacement. Moreover, VEGF reversed cavernosoetric findings of leakage (4).
The above studies and others not cited indicate an improvement in the health, circulation, and strength (density) of penile tissue with injection of blood-derived growth factors into the penis.
What Goes with the Shot?
In regards to improvement in erection firmness, the Priapus Shot® protocol also includes a recommendation of aerobic exercise which by meta analysis of 5 randomized controlled studies using the Erectile Function Scale showed an increase of 5 (5,6).
As previously stated, the complete Priapus Shot® protocol, also includes the use of a penis pump, which as a stand-alone therapy has been demonstrated to improve erection both as part of a penile rehabilitation program as well as an adjunct to other therapies (7,8).
This same penis pump strategy, even without the PRP, has been demonstrated to increase penis size by 2-3 cm, while traction (another physical therapy that can be included as part of the Priapus Shot® protocol) was shown to increase penis length by 1.5-2.5 cm (8, 9). Adding PRP to the protocol shows improved results according to data collected by urologists currently utilizing the Priapus Shot® protocol (to be presented). The 2.5 cm improvement seen with the penis pump alone is in the 10-20% growth range for the average sized penis. As previously stated, while patient results vary, any patients that are not happy with the procedure are given a complete refund.
Ultrasound studies of humans, post treatment, by Dr. Virag and by other physicians who offer the Priapus Shot® protocol demonstrate improved blood flow, an increase in endothelium (improved health), and decreased plaque size. Dr. Joseph Banno of Chicago recently presented a paper showing the Priapus Shot® procedure decreased venous leak as well as increased intra-penile arterial pressure.
Dr. Virag’s studies, using the injection of PRP as a stand-alone (without physical therapies), also demonstrate improvement in the angle of the penis in men suffering with Peyronie’s disease (3). Also, strict adherence to a penis pump regimen is part of the Priapus Shot® protocol and the pump alone improves the angle significantly in over one-half of those studied in one study in the British Journal of Urology (10). This same study demonstrated growth of the penis using the pump alone (without the PRP injection). The PRP alone, in Dr Virag’s study, out-performed the pump with demonstration of remodeling of the plaque. I recommend using both methods: vacuum pump and Priapus Shot®.
Studies show that the non-surgical treatment of Peyronie’s is most effective when a synergy of multiple modalities is engaged (11). So, the Priapus Shot® procedure includes the injection of PRP (demonstrated effective by Dr. Virag) combined with daily physical therapy using a penis pump for ten minutes twice a day and a daily low-dose of taladafil. Other modalities in the Priapus Shot® procedure that have been demonstrated to be synergistic include the following: stopping smoking, CoQ10 (12), vitamin E (13), trimix, and aerobic exercise. Such strategies are not intended to take the place of surgical correction or of the use of chemical surgery with collagenase—but rather to offer the man suffering with Peyronie’s disease the optimal non-surgical treatment as a first step with surgery reserved if non-surgical therapies fail.
The penis pump alone (part of the Priapus Shot® protocol) has been shown to improve the effectiveness of Cialis and of Trimix injections (8). We are seeing men decrease the dosage of Viagra and/or Trimix by about 50 percent when the complete Priapus Shot® protocol is used. The Priapus Shot® protocol does not intend to make any particular therapy obsolete (including surgery) but rather to offer a protocol for enhancing an overall, synergistic approach to correcting penile pathology. However the surgical treatment of Peyronie’s disease can be unsatisfying and lead to serious complications (14); we (the Priapus Shot® providers) are seeing the safety profile of PRP and the Priapus Shot® protocol as offering an appealing conservative and often effective step to take before proceeding to surgery. The risk from PRP is certainly much less than for surgery and less than for collagenase—offering another reason to start with the Priapus Shot® when treating Peyronie’s or erectile dysfunction.
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When considering the duration of effectiveness of the Priapus Shot® procedure and risks involved, you may find it helpful to consider the nature of the cell biology employed. A review article considering the basic science of PRP discusses the fact that the autologous growth factors are exactly what’s generated to propagate healing should the man have surgery. The healing peptides, chemotactic factors, and pluripotent stem cells employed are exactly what’s generated by the normal healing process and offers no inherent risk for infection or allergy (16).
In over 8,000 papers published about PRP on pub med, there is not one serious sequelae reported that I can identify (multiple review articles address safety). This seems logical when you consider the material being injected is autologous and normally produced to help healing and to fight infection.
Wound care studies demonstrate the nature of multiple tissue types being regenerated (with no reported risk of neoplasia in multiple biopsy studies (17-20).
Moreover, in rat studies (where biopsy of the dorsal nerve is feasible), PRP has been shown to help regenerate nerve tissue and restore erectile function when prostate surgery is modeled with crush injury to the dorsal nerve (21,22). Some studies of stem cell therapies demonstrate that the stem cells do not actually mature into healthy tissue but rather signal for the improvement of the involved ganglion and nerve conduction by recruitment of stem cells to the area - exactly what happens with PRP.
Stem cells are not directly prepared as part of the Priapus Shot® procedure, but we are seeing similar results as what’s reported with stem cell studies. Stem Cell studies often use PRP as a carrier for the stem cells, bringing into question which is the active agent (23-24).
The idea of safety is further emphasized by the literature indicating that not only are there no reports of serious allergic reactions to PRP, but research also shows that PRP can attenuate the autoimmune response. One split-scalp study (with placebo control) showed improvement in alopecia areata, with the use of PRP, that out-performed triamcinolone (25). Another study using PRP in the genitalia of women, showed improvement in lichen sclerosus as determined by both patient survey and by 2 blinded dermatopathologists (26). This attribute of PRP (attenuation of the autoimmune response) could partly explain the effectiveness of the Priapus Shot® protocol for the treatment of both Peyronie’s disease and erectile dysfunction since Peyronie’s is thought to be partly caused by an autoimmune response.
Hard & Easy Cases
Hard Cases
- Penis Growth-Only 60% of men achieve 1/2 inches or more in growth (circumference and length). But, men in that 60% sometimes see up to 1.5 inches in circumference & length (often after 2 to 3 procedures).
- Men with long-standing vascular disease see less response. If the blood flow going to the penis (ileac arteries) is blocked, then the Priapus Shot® injection into the penis will not help much. The man needs a vascular surgeon. One way to get an idea here….if the man sees absolutely no response when taking Viagra or Cialis for more than 2 years, then he may have blockages or other problems that the Priapus Shot will not help.
Easy Cases
- Post op for prostate surgery as part of a penile rehabilitation program. If the man could achieve erection before the surgery, the following the Priapus Shot® protocol could be very beneficial (even if it’s been 2 or 3 years since surgery).
- Improved firmness of erection in the man who can already achieve erection. Typical results are that he may be able to cut the dose of Viagra or Trimix in half (but still need the drug) or if he needs only a low dose of the drugs he may be able to stop using them.
- Improvement in lichen sclerosus. This is HUGE since lichen sclerosus appears on the foreskin with severe discomfort and often recurs even if the man has a circumcision.
- Peyronie’s Disease. This possibility is another HUGE benefit of the procedure—with the Priapus Shot® probably safer and more effective than collagenase injections (research to be published soon). If a man undergoes surgery for Peyronie’s disease, the curvature often recurs later since the autoimmune process continues. Also, with surgery, there can be infection and shortening of the penis. None of those side effects have been seen with the Priapus Shot® procedure (side effects include INCREASE in size in most men with Peyronie’s).
Summary
In summary, multiple studies support the idea that blood-derived growth factors (when prepared in a proper way using a kit approved by the FDA for the preparation of PRP), as used in the Priapus Shot® protocol, support the health and function of the penis. Erectile dysfunction is associated with anhedonia, and successful treatment leads to better function, better relationships, and more pleasure in life (27).
Hope you find this helpful!
Peace & health,
Charles Runels, MD
Inventor of the Priapus Shot® Procedure
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References
2. Garcia MM, Fandel TM, Lin G, Shindel AW, Banie L, LinC-S, and Lue TF. Treatment of erectile dysfunction in the obese type 2 diabetic ZDF rat with adipose tissue-derived stem cells. J Sex Med 2010;7:89–98
4. Rogers R. Intracavernosal vascular endothelial growth factor (VEGF) injection and adeno-associated virus-mediated VEGF gene therapy prevent and reverse venogenic erectile dysfunction in rats. International Journal of Impotence Research. 2003;15:S24-9.
5. Lamina S, Agbanusi E, Nwacha RC. Effects of Aerobic Exercise in the Management of Erectile Dysfunction: A Meta Analysis Study on Randomized Controlled Trials. Ethiopian Journal of Health Sciences. 2011;21(3):195-201.
6. Esposito K, Giugliano F, Di Palo C, et al. Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: A Randomized Controlled Trial. JAMA. 2004;291(24):2978-2984. doi:10.1001/jama.291.24.2978.
8. Pahlajani G,Raina R, Jones S, Ali M, and Zippe C. Vacuum erection devices revisited: Its emerging role in the treatment of erectile dysfunction and early penile rehabilitation following prostate cancer therapy. J Sex Med 2012;9:1182–1189.
9. Sellers T, Dineen M, Wilson SK. Vacuum protocol and cylinders that lengthen allow implantation of longer, inflatable prosthesis. Toronto, ON: (Abst) Society of Sexual Medicine; 2008.
10. Raheem A. The role of vacuum pump therapy to mechanically straighten the penis in Peyronie's disease. BJU Int.. 2016;117(4):E7.
12. Safarinejad M. Safety and efficacy of coenzyme Q10 supplementation in early chronic Peyronie’s disease: a double-blind, placebo-controlled randomized study. International Journal of Impotence Research. 2010;22(5):298-309.
14. Lue T. The Challenges of Peyronie's disease. Translational Andrology & Urology. 2012;1(S1):PS 9.
16. Sanchez-Gonzales J. Platelet-Rich Plasma Peptides: Key for Regeneration. International Journal of Peptides. 2012;10:1-10.
18. Yuan T, Zhang C-Q, Wang JH-C. Augmenting tendon and ligament repair with platelet-rich plasma (PRP). Muscles, Ligaments and Tendons Journal. 2013;3(3):139-149.
20. Conde-Montero, E., Horcajada-Reales, C., Clavo, P., Delgado-Sillero, I. and Suárez-Fernández, R. (2014), Neuropathic ulcers in leprosy treated with intralesional platelet-rich plasma. Int Wound J. doi:10.1111/iwj.12359
22. Ding X. Platelet-rich plasma on the Cavernous Nerve Regeneration. Chinese Medical journal. 2008;88(36):2578-2580.
27. Goldstein A., Runels C. Intradermal Injection of autologous platelet-rich plasma for the treatment of vulvar Lichen sclerosus. Journal of the American Academy of Dermatology. 2017;76(1):158-160
Dr. since you are the Guru of all please advise me on the situation from this disease at the base and Can that help If you go to my Peyronies.com you’ll read all the men that have situations that don’t seem to work And most doctors say there is no cure surgical is the only way please help