Category Archives: Research

When Should You Treat Peyronie’s with the P-Shot® Procedure…Early After Onset, or Later?

Question (name changed)...

Dr. Runels:

I'm an ENT doctor but in this case a urology pt with recent-onset (noticed 2-3 weeks ago) Peyronie's. My urologist ______ in ______ gave me your flier about the Priapus Shot® treatment.

(1) Does your Rx address the plaques?

(2) Does it stop or reverse the Peyronie's process?

(3) Is it better to treat early (now) or wait 8-10 months when the plaques stabilize?

Thank you.

Answer:

(1) Yes! Research shows a decrease in plaque size.
(see research listing below)

(2) If you mean, does the Priapus Shot® procedure help the curvature? Yes, in most men.  If you mean, does it permanently reverse the underlying process so the curvature never recurs...then probably in some. To further elaborate with some data, we did the following research (click to read) with lichen sclerosus (also thought to be an autoimmune process, like Peyronie's), showing that our process with the O-Shot® procedure decreased inflammation according to 2 blinded dermatopothologists--indicating that somehow the procedure down-regulates the autoimmune response.  There are other papers showing this downregulation of the autoimmune process by PRP.

Further as to permanence, our provider group has seen women who see a recurrence of their lichen at 1 year out, a few who are not helped at all, and many who are still well at 3-4 years post procedure. How these data will relate to Peyronie's disease remains to be seen but we expect a similar spectrum.
(see research listing below)

(3) DEFINITELY  better to treat early  before the scar tissue matures. I saw Dr. Virag lecture in Venice this past summer when we shared the podium and he will soon publish data showing that using PRP is more effective and safer than Xiaflex. Depending on how you look at the data, Xiaflex has a 1 in 50 to 1 in 100 risk of fracture/impotence post procedure. The Priapus Shot® procedure has associated with it the probable side effect of an improvement in erection quality by around 5 - 7 on the 25 point scale commonly used.
(see research listing below)

IMPORTANT! If your provider is not on the following list of physicians who have studied the accepted methods of the Priapus Shot® procedure (click) and agreed to follow them, then your physician may be a wonderful provider, but I have no way of knowing who or how he/she was trained and what method he learned. So, I have NO way to make any comments about the quality of the procedure he/she may provide. What I can say, is that your physician (if she/he says he's providing the P-Shot® but is not listed on that directory) is either knowingly or unknowingly breaking the law and pretending to be part of a group that he/she is NOT a part of. The certified providers of the Priapus Shot® procedure share notes with each other, finance research, and support the advancement of the effectiveness of the procedure. THOSE WHO USE THE NAME "PRIAPUS SHOT" BUT WHO ARE NOT LISTED AS ONE OF OUR MEMBERS ARE USING THE FRUITS OF OUR LABORS ILLEGALLY and possibly providing and inferior service by deceiving patients.

Certified Members of the Priapus Shot® Provider Group (click)<--
Research Listings for the Priapus Shot® Protocol for Treating Peyronie's Disease (click to read)<--

Best regards,

Charles Runels, MD

 

Inventor of the Priapus Shot® Procedure

 

Straighter, Harder, Bigger. Step 3. Priapus Shot®

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).

Find Certified Priapus Shot® Provider (click)<==

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.

Apply for Certification as Priapus Shot® Provider (click)<==

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

Apply for Certification as Priapus Shot® Provider (click)<==

Find Certified Priapus Shot® Provider (click)<==

References

1. Siroky M. Vasculogenic erectile dysfunction: newere therapeutic strategies. J Urol. 2003;170(2 Pt 2):S24-9.

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

3. Virag R. A New Treatment of Lapeyronie’s Disease by Local Injections of Plasma Rich Platelets (PRP) and Hyaluronic Acid. Preliminary Results. e-mémoires de l'Académie Nationale de Chirurgie. 2014;13(3):96-100.

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.

7. Nikolai S. Erection rehabilitation following prostatectomy--current strategies and future directions. Nature Reviews Urology. 2016;13(.):216-225.

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.

11. Levine L. Peyronie’s disease: contemporary review of non-surgical treatment. Transl. Androl. Urol. 2013;2(1):39-44.

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.

13. Paulis G. Efficacy of vitamin E in the conservative treatment of Peyronie's disease: legend or reality? A controlled study of 70 cases. Andrology. 2013;1(1):120-128.

14. Lue T. The Challenges of Peyronie's disease. Translational Andrology & Urology. 2012;1(S1):PS 9.

15. Raynor M. Dorsal Penile Nerve Block Prior to Inflatable Penile Prosthesis Placement: A Randomized, Placebo‐Controlled Trial. The Journal of Sexual Medicine. 2012;9(11):2975-2979.

16. Sanchez-Gonzales J. Platelet-Rich Plasma Peptides: Key for Regeneration. International Journal of Peptides. 2012;10:1-10.

17. Taylor D. A systematic review of the use of platelet-rich plasma in sports medicine as a new treatment for tendon and ligament injuries.. Clin J Sport Med. 2011;21(4):344-52.

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.

19. Sell S. A case report on the use of sustained release platelet-rich plasma for the treatment of chronic pressure ulcers. The Journal of Spinal Cord Medicine. 2011;34(1):122-7.

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

21. Ding X. The effect of platelet-rich plasma on cavernous nerve regeneration in a rat model.. Asian J Androl. 2009;11(2):215-21.

22. Ding X. Platelet-rich plasma on the Cavernous Nerve Regeneration. Chinese Medical journal. 2008;88(36):2578-2580.

23. Rene' Y. Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study. European Urology. 2016;69(6):988-991.

24. Fandel T. Recruitment of Intracavernously Injected Adipose-Derived Stem Cells to the Major Pelvic Ganglion Improves Erectile Function in a Rat Model of Cavernous Nerve Injury. European Urology. 2012;61(1):201-210.

25. Singh S. Role of platelet-rich plasma in chronic alopecia areata: Our centre experience.. Indian Journal of Plastic Surgery. 2015;48(1):57-9.

26. Goldstein A. ISSVD 2015 Abstracts. Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25.

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

27. Zaman H. Association of psychological factors, patients’ knowledge, and management among patients with erectile dysfunction. Patient Preference and Adherence. 2016;10:807.

Save

Save

Peyronie’s & ED Treatment: The Priapus Shot® Procedure

Priapus Shot® Procedure

The Priapus Shot® procedure indicates a specific protocol for treating the penis with blood-derived growth factors: specifically platelet-rich plasma or PRP. 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 warrant protection as intellectual property and so would not indicate any particular quality of care.

The trademark gives a method of teaching a specific protocol that providers agree to follow and develop; this agreement offers a measure of quality control and is being followed and developed by around 500 urologists and interventional radiologists, family practitioners, and internists in multiple countries and by faculty in several medical schools where further studies are being done.

The Priapus Shot® procedure defines a protocol that 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. Other post injection steps can include: stopping smoking, CoQ10 (12), vitamin E (13), Trimix, and aerobic exercise. Protocol steps can vary depending on the problems presented by the patient.

It is the policy of most of our providers of the procedure to offer any patient that is not happy with the Priapus Shot® procedure a complete refund.

Find Priapus Shot® Provider <--

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.

Consulting the patient includes informing him that unexpected side effects could occur and the results can vary with some patients seeing no benefit.

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. Multiple kits have gained FDA approval. Some of the approved kits include Regen, Magellan, TruPRP, Eclipse, Pure Spin, & Emcyte. There are over 8,000 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.

The first indication that PRP may be useful in the penis is in a paper published in Urology in 2003 indicating that, in animal models, using growth factors was successful to treat erectile dysfunction and indicated that such a strategy may be feasible in men— actually providing a way to correct underlying pathology (1). Viagra and Trimix do not correct underlying pathology of penile circulation.

Another animal model study in 2010 showed that transferring adipocyte derived stem cells (ADSCs) into the penis caused endothelia cell growth as well as increased nitric oxide activity in the dorsal nerve. Interestingly, the ADSCs were tagged and perished - so the improvement seen was not from maturation of the ADSCs but rather from recruitment and activation by growth factors of stem cells from within the body. Also, indicating the PRP may demonstrate a similar effect (2).

Dr. Virag (also a pioneer of Trimix injections) published a paper 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 the corpus cavernosum of the human penis (3).

One of the growth factors (over 20 known) found in PRP includes vascular endothelial growth factor (VEGF). In one animal model study, the animals were castrated to create a penis that demonstrated, on microscopy, atrophy of smooth muscle and nerves as well as endothelial cell pathology. Injecting VEGF directly into the corpus cavernosum 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.

In regards to improvement in erection firmness, the Priapus Shot® protocol also includes a recommendation of aerobic exercise which by metaanalysis of 5 randomized controlled studies using the IIEF 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 later this year. It should be noted that 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 the physicians currently utilizing the Priapus Shot® protocol demonstrate improved blood flow and an increase in endothelium (improved health) as well as such results being indicated animal model studies, only some of which have been cited.

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) though the growth was not as significant as in the other studies previously cited. The PRP alone, in Dr Virag’s study, out-performed the pump with demonstration of remodeling of the plaque.

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. Further, other modalities are also used in the Priapus Shot® procedure that have been demonstrated to be synergistic: 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 Priapus Shot® protocol does not intend to make any particular therapy obsolete but rather offer a protocol for enhancing an overall, synergistic approach to pathology of the penis. The surgical treatment of Peyronie’s disease can be unsatisfying and lead to serious complications (14); we are seeing the safety profile of PRP and the Priapus Shot® protocol offer an appealing conservative step to take before proceeding to surgery.

For, example 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.

Most men find the procedure very comfortable if a topical lidocaine cream is used since a 1/2 inch 30 gauge needle is used for injection (similar to a Trimix injection). However, some men do ask for a dorsal nerve block which can easily be done using 1% lidocaine without epinephrine for a near painless procedure (since this same block can be used for prosthesis placement, it makes a 30 gauge needle completely painless for most men) (15).

Considering the duration of effectiveness and risks involved it’s useful to consider the nature of the cell biology employed. A review article considering the basic science 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 offered 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 article speaks of the 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, that of 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.

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).

References

1. Siroky M. Vasculogenic erectile dysfunction: newere therapeutic strategies. J Urol. 2003;170(2 Pt 2):S24-9.

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

3. Virag R. A New Treatment of Lapeyronie’s Disease by Local Injections of Plasma Rich Platelets (PRP) and Hyaluronic Acid. Preliminary Results. e-mémoires de l'Académie Nationale de Chirurgie. 2014;13(3):96-100.

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.

7. Nikolai S. Erection rehabilitation following prostatectomy--current strategies and future directions. Nature Reviews Urology. 2016;13(.):216-225.

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.

11. Levine L. Peyronie’s disease: contemporary review of non-surgical treatment. Transl. Androl. Urol. 2013;2(1):39-44.

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.

13. Paulis G. Efficacy of vitamin E in the conservative treatment of Peyronie's disease: legend or reality? A controlled study of 70 cases. Andrology. 2013;1(1):120-128.

14. Lue T. The Challenges of Peyronie's disease. Translational Andrology & Urology. 2012;1(S1):PS 9.

15. Raynor M. Dorsal Penile Nerve Block Prior to Inflatable Penile Prosthesis Placement: A Randomized, Placebo‐Controlled Trial. The Journal of Sexual Medicine. 2012;9(11):2975-2979.

16. Sanchez-Gonzales J. Platelet-Rich Plasma Peptides: Key for Regeneration. International Journal of Peptides. 2012;10:1-10.

17. Taylor D. A systematic review of the use of platelet-rich plasma in sports medicine as a new treatment for tendon and ligament injuries.. Clin J Sport Med. 2011;21(4):344-52.

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.

19. Sell S. A case report on the use of sustained release platelet-rich plasma for the treatment of chronic pressure ulcers. The Journal of Spinal Cord Medicine. 2011;34(1):122-7.

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

21. Ding X. The effect of platelet-rich plasma on cavernous nerve regeneration in a rat model.. Asian J Androl. 2009;11(2):215-21.

22. Ding X. Platelet-rich plasma on the Cavernous Nerve Regeneration. Chinese Medical journal. 2008;88(36):2578-2580.

23. Rene' Y. Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study. European Urology. 2016;69(6):988-991.

24. Fandel T. Recruitment of Intracavernously Injected Adipose-Derived Stem Cells to the Major Pelvic Ganglion Improves Erectile Function in a Rat Model of Cavernous Nerve Injury. European Urology. 2012;61(1):201-210.

25. Singh S. Role of platelet-rich plasma in chronic alopecia areata: Our centre experience.. Indian Journal of Plastic Surgery. 2015;48(1):57-9.

26. Goldstein A. ISSVD 2015 Abstracts. Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus. Journal of Lower Genital Tract Disease. 2015;19(3):S1-S25.

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

27. Zaman H. Association of psychological factors, patients’ knowledge, and management among patients with erectile dysfunction. Patient Preference and Adherence. 2016;10:807.

Peyronie’s & ED Treatment…”Supplements & Foods that Cause a Harder Straighter Erection”…


(scroll down to read transcript of this video)

Priapus Shot Providers (click) <--

Resources & References (Video Explains)...

    • Pycnogenol

        


  • Double blind study of Co-Q10 (click to read)<--
    • 186 men with "early chronic" Peyronie's got 300mg Co-Q10 per day. The other group got placebo.
    • No other treatment!
    • At the end of 6 months...
      • Placebo group-average plaque size and curvature increased. 56% of the men in the group were worse. No one was better.
      • In the men who took 300mg Co-Q10, average plaque size and curvature improved and erectile function improved! Only 13.6% of the men worsened.
    • Conclusion. Co-Q10 prevents worsening 87% of the time, and improves curvature & erectile function & decreases plaque size in most men after 6 months of treatment.
    • Recommended Co-Q10. This is a 6 month supply of high quality in 1 bottle. Put this buy where ever you have your morning meal or protein shake and take with that....

      


  • Vitamin E used in combination with other therapies. (Click to read)<--
    • Men with Peyronie's were divided into 2 groups and treated for 6 months.
      • In 1/2 of the men, vitamin E  at a does of 1,200 IU was give once a day as part of a combination therapy.
      • The other 1/2 got the combination therapy without the vitamin E
    • The men who did not get the vitamin E saw and average decrease in curvature of 6 degrees. Average reduction in plaque was 36%. Of the men treated, 48% improved.
    • With the men who DID get vitamin E, an average decrease in curvature of twice as much occurred--12%. The average plaque reduction was 50% and of the men treated 96% improved!
    • No one in the vitamin E group saw a worsening of the curvature or an increase in the size of the plaque. Some of the men who did not take vitamin E did see an worsening of the curvature with 17% of them seeing an increase in the size of the plaque!
    • The vitamin E group also saw a more significant increase in erectile function.
    • This is a wonderful example of the "fire" analogy. Sometimes it takes more than  1 thing a the same time to build a fire.
    • One of each of these per day gives 1,250 IU's (1,000 + 250) with an excellent quality and a few cofactors that help the E work better...

         <--one of these + one of these-->

Beginning of Transcript of Webinar...

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save

Save