New Research Shows Alternative Protocol to be Inferior to the P-Shot® (Priapus Shot®) Procedure

Researchers (Masterson, 2023) recently used a protocol (that differs from the P-Shot® procedure) and measured the effect on erectile function of injections of the penis with platelet-rich plasma (PRP).

Their protocol was less effective than what previous studies have shown. You can read the article here<--

Before reviewing their research and their deviations from the P-Shot® protocol, consider what the P-Shot® is: The P-Shot® (Priapus Shot®) is a service mark that names a procedure that requires training in the standard protocol and an agreement to follow the protocol that has been used (with improvements) for the past 13 years.

The ways Masterson, et al changed the procedure (from that of the P-Shot® procedure) for their study include at least all of the following:

1. They used a different injection technique than what is used with the P-Shot® procedure; their technique limited the exposure of the penis to less than 1/2 of the tissue treated by the P-Shot® procedure.
2. They used a centrifuge that is not on the recommended list of devices approved by the FDA for the preparation of PRP for injection back into the body. Their centrifuge also differs from what was used in other studies that showed benefits.  The centrifuge used can have dramatic effects on not only the number of platelets but also the number of white blood cells and red blood cells in the sample--all of which is important in regard to results.
3. They injected 1/2 the volume of PRP usually injected. They injected a total of 5 cc instead of 10 or more cc's. So not only did their injection technique limit the distribution, but the volume injected limited the treatment area and the number of platelets.
4. They did not activate the PRP with Calcium Chloride (or with any agent at all). Without activation, the PRP is more prone to washout, and the growth factors in their 1/2 dose are further limited by being more shortlived than with the P-Shot® procedure. There is a huge difference between the growth factor spectrum and the duration of effect when the activation is modified.

   

   ---

Other points about the study:

1. They calculated sample size based on the assumption that the placebo group would have a 15% rate of attaining MCID, not the observed 50%; so the study was grossly underpowered and conclusions invalid.  Still, we can look at more...

2. Even though they saw less response (with their altered protocol) than what has been shown in other studies, they still saw improvement in erectile function after injection of PRP; the change was just not significantly greater than saline. Both showed improvement.

3. Also, what they called a placebo, saline, has been shown to have regenerative properties when injected directly into tissue. When injected iv to compare with a drug, saline is an adequate placebo. When injected into tissue, it has been shown to help improve joint disease and help with leishmaniasis, granuloma annulare, and atrophic acne scars--saline, when injected into soft tissue, is not a placebo.

"Even when used as a control, saline exerts some therapeutic action in different dermatological indications, including warts, acne scars, and rejuvenation." (El-Amawy, 2020)

4. In previous double-blind, placebo studies of PRP for ED, PDE5is were discontinued. In one study, the placebo response (still using saline) was only 15%. Masterson, et al allowed participants to continue their Viagra drugs, which could account for the higher placebo response. The high placebo response also attenuates the power of the study.

5. The study is also compromised mathematically by a 15% dropout rate in an already small sample size.

6. In their introduction, Masterson et. al writes the following: "Even without supporting data, numerous clinics in the largest metropolitan areas of the United States are charging patients for PRP treatments for ED."

Yet, there IS "supporting data." Previous studies indeed have shown that PRP does help with ED and with Peyronie's disease One of those studies was even done by Dr. Ronald Virag, the pioneer in urology who came up with the idea that became "tri-mix" injections for erection and changed urology forever.

The authors failed to recognize all of those studies by stating there is "no supporting data."

7. They do, later in their discussion, contradict/correct their own statement ("no supporting data") by making reference to two of many articles that support the P-Shot® procedure and the injection of PRP for ED.

Then, they reference an article in JAMA that later required a printed correction; but make no reference to the correction, which undermines their point.

8. Also, the authors fail to point out, in their worries about the money being charged, that the P-Shot® procedure has fewer side effects than Viagra (which has been shown to cause blindness in some) and its cousin drugs and that the cost of a P-Shot® can be less than pharmaceutical alternatives (over time), much less invasive and less expensive than a penile implant, and that P-Shot® providers have agreed to refund the money of anyone not helped by the procedure.

The P-Shot® in no way makes these alternative treatments not useful and needed. But, the P-Shot® should be part of the tools available for treatment, and a man should be able to try the P-Shot® before proceeding to implant.

9. Moreover, the Priapus Shot® procedure is NOT just to give a shot. The procedure includes an evaluation to see if the shot is appropriate. There must be phlebotomy (usually another skilled employee's time and expense) and processing of blood using FDA kits approved for processing blood for autologous reinjection (not cheap). The cost to the patient helps covers these expenses.

10. Other studies have shown a greater improvement in erectile function than what was seen by these authors. So, we are grateful for their contribution--showing that a different protocol works less well. Further studies are needed to look at the variables regarding the preparation of the PRP, activation, and injection technique to understand further why their protocol was less effective and how current protocols can be improved.

11. Also, further studies are needed regarding combination therapies. For example, one prospective, randomized, controlled study showed that PRP greatly improved the results seen with shock waves for erectile dysfunction.

In conclusion, Masterson et al demonstrated (in this underpowered study using a placebo that is not a placebo) that injecting 1/2 the volume of the P-Shot® procedure using their alternative technique of injecting and not activating the PRP with CaCl is possibly less effective than what has been shown in other studies. That is valuable to know, and we are grateful for their study.

To find the nearest P-Shot® (Priapus Shot® provider)<--

To apply for training for the P-Shot® procedure<--

Charles Runels, MD
Cellular Medicine Association
1-888-920-5311
DrRunels@Runels.com

References

References Regarding the Benefits of the P-Shot® Procedure for ED

References Regarding Saline is Not a Placebo

References Regarding the Activation of PRP