Regenerative Therapy and the P-Shot: Why We Call It Investigational

There is a straightforward conflict of interest in writing this article, so let us put it at the top. Platelet-rich plasma injection is a procedure we offer, it is priced in the low four figures, and a portion of the men who read this and decide against it represent revenue we will not receive. We think the article is worth writing anyway, and you should weigh what follows knowing that.

The premise, which is reasonable

Platelets do more than clot. They carry a dense payload of signalling proteins — platelet-derived growth factor, transforming growth factor beta, vascular endothelial growth factor — that coordinate tissue repair. Concentrating them and delivering them into damaged tissue is a well-established idea in orthopaedics and wound care.

Applying that to erectile tissue is a logical extension. The procedure is simple: draw your blood, spin it to separate the platelet-rich fraction, inject that concentrate into the corpora cavernosa under topical anaesthetic. Nothing from a donor, nothing synthetic, no drug.

Logical extensions are not the same as demonstrated results, and that gap is the whole subject of this article.

What the human evidence actually consists of

A handful of small randomised and observational studies. Some report modest improvement in IIEF scores in men with mild to moderate erectile dysfunction. Others show effects that do not separate convincingly from placebo. Sample sizes are small throughout.

The deeper problem is that the studies are not really studying the same thing. Preparation protocols differ between clinics and between trials — spin speed, number of spins, final platelet concentration, whether the platelets are activated and how. Two clinics both offering PRP may be injecting materially different preparations. That makes results difficult to compare and difficult to reproduce, which is precisely the situation in which an evidence base fails to consolidate.

• The FDA has not approved PRP for erectile dysfunction.
• There is no standardised preparation protocol, so 'PRP' does not describe one product.
• The trials that exist are small, and results are inconsistent between them.
• Longer-term durability data is thin.

An unproven treatment is not the same as a disproven one. But it is also not the same as a proven one, and the marketing in this field routinely collapses that distinction.

About the branded version

Much of this is sold under a trademarked name — the P-Shot being the best known. It is worth understanding what that branding is and is not.

It is a trademarked protocol, not a distinct drug. The underlying material is autologous platelet-rich plasma in both the branded and unbranded case. A clinic paying to use the trademark has bought a name and a procedure specification. It has not acquired additional clinical evidence, and the trademark does not confer any.

So when you see the branded name presented as though it were an established treatment with its own evidence base, that is a marketing artefact rather than a clinical fact.

Where it might reasonably fit

Our position is narrow and we will state it as narrowly as we hold it. PRP is reasonable to consider as an adjunct for a man who has mild to moderate vasculogenic erectile dysfunction, who understands he is choosing an unproven therapy, who has realistic expectations, and who is not deferring an effective treatment in order to pursue it.

That last clause carries most of the weight. A man who has never had a proper trial of oral medication should do that first — it is cheaper, better evidenced, and more likely to work. A man for whom oral therapy has genuinely failed at maximum dose has second-line options with response rates in the seventy to ninety per cent range. PRP is not competing with those on evidence, and it should not be sold as though it were.

It is sometimes used off-label as an adjunct in early Peyronie's disease, where the same caveats apply.

What we do to keep ourselves honest

The expectation-setting conversation happens before anything else, and a meaningful number of men decline at that point. We regard that as the process working rather than failing.

Then we re-score at three months against a documented baseline. If there is no measurable benefit, we say so and we stop. We do not sell open-ended courses of a therapy that has not demonstrated it is doing anything, and a clinic that keeps recommending further sessions without showing you a number that moved is not treating you, it is billing you.

The test to apply anywhere

If a clinic offers you a regenerative therapy, three questions will tell you most of what you need to know. Is this FDA-approved for this indication — and if not, do they say so unprompted? What specifically will be measured, when, and against what baseline? And what happens if the number does not move?

A clinic with good answers to those is worth listening to. A clinic that describes an investigational therapy as a breakthrough, cannot tell you what it will measure, and has no defined stopping point is selling hope with a needle attached — and hope, in this field, is expensive.