Reproduced from Dr Charles Runels,Website www.priapusshot.com
​Pioneer of the P Shot​®
​https://www.priapusshot.com/members/fda-approved/

Is The P Shot® FDA Approved?
Answer...Great to hear from you and I’m very happy that you’re helping out our provider!
     Here’s a few points that answer your questions:

1. The P-Shot® (Priapus Shot®) uses a man's own blood. So, the P-Shot is not FDA approved because the FDA (Food & Drug Administration) NEVER approves procedures. It’s not what they do.The best analogy is when a doctor sutures a wound. The FDA approves the DEVICE of the suture material. But, how the doctor uses the thread to suture the skin back together is up to the doctor (not the FDA). So you could say it's the "Food & Drug/Device Administration" but not the "Food & Drug/Device and Body Parts Administration."People own their own blood, and urine, and saliva.The FDA does NOT govern the body or body parts or body fluids.. nor does the FDA govern what a doctor does with a patient’s blood or urine or body parts—these are not drugs. The FDA does govern the devices use to prepare blood to go back into to the body (to prepare the PRP) and your doctor should be using an FDA approved kit.
2. So when someone criticizes the procedure and says it’s not FDA approved, it’s like saying my car or my toenail is not FDA approved…so whoever says that needs us to educate them…and here’s where it can help your marketing…You should make sure people know that all the doctors who to the Priapus Shot® procedure (including yours) use an FDA approved device to prepare the blood (other doctors who are not in our group often do not use an FDA-approved device). Also, we have a well planned and protected way of injecting the PRP into the penis and a whole protocol for before and after the procedure. 

So I've always had a Woolworth's bladder, right from being a teen, after a few beverages with my raucous teenage friends, I'd spend most of the night frequenting the bathroom or back of the shed depending on where the festivities took us. Things never really changed, my 20's, 30's and into my 40's the frequency and irritation of never ending pee stops, and getting up in the middle of the night was continuous. Urology visits, endoscopies, urine flow charts, Bloods-PSAs, exclusion tests for Prostate & Bladder Cancer and please bend over examinations were (are) common for me.
My diagnosis BPH (Benign Prostatic Hypertrophy) and Irritable Bladder Neck. Not so bad on the face of it. However at one point there was discussion of surgical treatment for my prostate to relieve my symptoms as oral medication was adversely affecting me.
Having trained as an Urgent Care Physician there's a tendency to think worse case scenario and work backwards from there .... so I'm thinking Prostate resection and possible impotence due to nerve damage, that's great ....... how do you fix that?
Yes Doctors can catastrophize things also .... so I started looking around at treatments available to help post prostate surgery if that's the way things were going to go for me.
I'd known about PRP treatments for 10 years plus, and knew that it had various applications. A colleague of mine had met Dr Charles Runels pioneer of the P Shot® and asked if I'd be interested in learning about this new treatment, which also had applications in sexual health. Given how I was personally affected I thought it would be great to see how the treatment could be applied in men with ED Erectile Dysfunction, and so I decided to take part in the learning and practical sessions in the application of the P Shot®. To be continued.

The three main problems addressed by the P-Shot® included erectile dysfunction (ED), Peyronie’s disease (PD), and lichen sclerosus (BXO). Though the prevalence of these problems in New Zealand could vary from that seen in the United Kingdom or the United States, in the US & UK, around 3% of men suffer with Peyronie’s disease with the prevalence of ED ranging from around 10% for men in their 40’s up to around 50% for men over 60. The prevalence of BXO varies greatly in the literature but could be at least 5%.

The usual treatments for these problems can be both frustrating and without correcting the underlying pathophysiology. For ED, neither penile implants, Viagra®, papaverine penile injections, nor vacuum pump therapy correct the underlying pathology of neurovascular disease. J Urol. 2003 Aug;170

With Peyronie’s disease, surgery can leave the penis shorter, risks ED, and the Peyronie’s can reappear, post op, at a new location on the penis—frustrating for both doctor and patient. Injectables for Peryonie’s disease have been not reliable until Xiaflex. But Xiaflex is a fifty-thousand US-dollar series of injections and carries with it the risk of penile fracture. Vacuum pump therapy helped 51% avoid surgery in one series, leaving the other half to need surgery.

For BXO, steroid creams may be used, but often require long term use. The definitive treatment, circumcision may still not be curative nor is it desired by some men.
So, for all three problems, there could be a need for another treatment option to used alone or in concert with the present therapies.

Platelet rich plasma has been the subject of over 9,000 research papers referenced on PubMed in the areas of wound healing, remodeling of scar tissuehttps://www.ncbi.nlm.nih.gov/pmc/?term=platelet+rich+plasma+scar+treatment, down regulating the autoimmune responsehttps://www.ncbi.nlm.nih.gov/pmc/?term=platelet+rich+plasma+autoimmune, regeneration of nerve tissue, helping prevent infection, and now research showing help with the improvement of the male and female genitalia.

For example, Dr. R. Virag, the vascular surgeon who helped develop the idea of papaverine injections for erectile dysfunction, is doing studies for the use of PRP in the treatment of both PD & ED e-mémoires de l'Académie Nationale de Chirurgie, 2014, 13 (3) : 096-100 .

​One study, he recently published, showed that PRP injections helped with PD better than Xiaflex and with fewer side effects (the side effect of the PRP is that erectile function improves)[] http://www.oatext.com/evaluation-of-the-benefit-of-using-a-combination-of-autologous-platelet-rich-plasma-and-hyaluronic-acid-for-the-treatment-of-Peyronies-disease.php .

Other studies of PRP - penile injections have shown improvement in BXO [] https://link.springer.com/article/10.1007%2Fs11255-017-1523-0 and ED https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5754585/, help with size https://www.jsm.jsexmed.org/article/S1743-6095(16)30656-7/fulltext, and with nerve repair post prostate surgery https://www.ncbi.nlm.nih.gov/pubmed/?term=platelet+rich+plasma+nerve+penis

In over 9,000 papers published on PubMed about the use of PRP, there has been not one report of serious infection, granuloma formation, neoplasia, fibrosis, or necrosis.

Erectile dysfunction occurs for a variety of reasons. It is not a disease, but a symptom of some other problem, either physical, psychological or a mixture of both. 
The causes can be categorized into the following groups
1) Psycho-social problems
2) Metabolic factors vessel function
3) Factors affecting blood flow
4) Factors affecting nerve function
5) Medications
6) Lifestyle effects
7) Urological problems
As our blog continues we will explore each of these factors in more depth.
Occasional failure in erectile function is quite normal, and can be the result of transient factors that are easily remedied such as poor sleep, excess alcohol or substances that can induce fatigue or sleepiness. Sometimes there are a number of factors working simultaneously to cause problems, therefore its important to tease out all of the potential causes and address each of these individually for a satisfactory outcome.