Clinical Efficacy and Safety of Two Injections of Platelet-rich Plasma in Erectile Dysfunction

19 Jun, 23

Introduction

Despite several treatments for erectile dysfunction (ED), patients may discontinue them either due to lack of efficacy or side effects. Therapies which reverse the underlying pathology and restore the natural spontaneous erections are needed. Platelet-rich plasma (PRP) contains various growth factors which may be beneficial in ED as per preclinical studies. However, there is paucity of clinical studies that evaluate the efficacy of PRP in ED.

Aim

This study evaluated the clinical efficacy and safety of 2 injections of PRP in the treatment of mild to moderate ED

Method

Study Design

Prospective, randomized, double-blind, placebo-controlled clinical trial

Patient Profile

Men aged 30 to 75 years with International Index of Erectile Function (IIEF) score of 11-25 for <6 months

Having normal testosterone levels
Having HbA1c <9%

Treatment Strategy

The cohort underwent physical examination and filled in IIEF-Erectile function domain and Sexual Encounter Profile-3 questionnaires
Blood tests for complete blood cell count, HbA1c and testosterone levels were done

A baseline penile duplex ultrasound was also performed to assess the vascular parameters
Eligible men with mild to moderate ED received either 2 injections of PRP or placebo separated by 28+7 days

Endpoints

Primary Endpoint

% men meeting minimum clinically important difference (MCID) at 1 month after the second injection

MCID is defined as an increase of 2 points for mild ED (starting IIEF-EF 17-25) and 5 points for moderate ED (starting IIEF-EF 11-16)

Secondary Endpoints

Change in IIEF-EF score at 1, 3 and 6 months
Changes in penile vascular parameters

Safety Endpoints

Incidence of adverse events (AEs)

Results

A total of 61 men were randomized into 2 groups: 28 received PRP and 33 received placebo
The difference between groups in percentage of men attaining MCID was not significant at 1 month (p=0.73) as seen in Figure 1.

Figure 1. % Men attaining MCID at Month 1

Mean change from baseline in IIEF-EF scores at month 1 was significant in both groups (3.7 in PRP vs 3.1 in placebo), however the difference between the groups was not significant; p=0.765
The results were similar at 6 months with mean increases of 5 vs 2.2; with no significant differences between the groups; p=0.116
None of the patients reported any major AE
Each group had 1 minor AE; new plaque in PRP group and hematoma in placebo group

There were no remarkable changes in penile Doppler parameters from baseline to 6 months

Conclusion

Administration of 2 injections of intracavernosal platelet-rich plasma (PRP) separated by 1 month was found to be safe in men with mild to moderate erectile dysfunction
However, there was no difference in the clinical efficacy between PRP and placebo

J Urol. 2023 Apr 30;101097JU0000000000003481.

Doi: 10.1097/JU.0000000000003481..