Intracavernosal injection of platelet rich plasma for treatment of erectile dysfunction

Phase 2/3

Active, not recruiting

Conditions: Male erectile dysfunction, unspecified,

Registration Number: CTRI/2023/09/058110

Lead Sponsor: All India Institute of Medical Sciences Raipur

Brief Summary: 1. Erectile dysfunction (ED) is failing to develop or maintain a penile erection. It is a common health and psychological issue affecting 22%-49% of 40-70-year-old males and is predicted to affect about 300 million males worldwide by 2025. Male sexual dysfunction symptoms are commonly experienced, although they are less commonly screened by, or brought to the attention of, health care providers. There is a substantial body of evidence that male sexual dysfunctions have a clear negative impact not only on the sexuality but also on the psychological and general well-being of men afflicted with these disorders and often on their partners. Hence, there is a continuing medical need for the development of new efficacious and safe treatment options.

The main pathology of ED is endothelial dysfunction in the blood vessels of the corpora cavernosa, which reduces the endothelial nitric oxide release and impairs vasodilatation. A therapy targeting this pathology would be the most effective. Despite the variable therapeutic modalities available for ED, such as oral erectogenic drugs, intraurethral injection devices, intra-cavernosal injection, and penile prosthesis, the focus is directed towards the regenerative medicine that eliminates the pathology and not just improves erection hemodynamic.

Platelet-rich plasma (PRP) therapy is based on injecting a small amount of a patientâ€™s blood after centrifugation to obtain plasma and platelet concentrate rich in growth factors like platelet-derived, vascular endothelial, insulin like, epidermal, and fibroblast growth factors. These factors have a major role in injured tissue regeneration. It is gaining

popularity and has been studied and approved in numerous medical and surgical disciplines. PRP has recently been used to treat ED through intra-cavernosal injections due to its angiogenic, vasculogenic, and regenerative properties. These properties made PRP a promising treatment for ED. PRP has been effective in many animal studies and is currently under evaluation in human trials. Recently few randomised control trials have been completed and are in various stages of publication. However, there is no published studies in Indian population.

Justification of the Study. We intend to do this study to see whether intracorporal injection of autologous platelet rich plasma really improves erectile function as compared to placebo in our subset of population. There is no published studies/RCT in Indian population as of now.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Male

Target Recruitment: 60

Inclusion Criteria

Male patients aged 21-75 years 2.
Patients with well-established chronic ED for at least 3 months 3.
IIEF-EF score 11-25 at screening (even if taking a single PDE5I) 4.
sexually active in a heterosexual stable partnership for at least 3 months will be considered for study 5.
Patients must be willing to comply with the key requests of the trial, namely to maintain regular sexual activities during the entire course of the trial with a mean frequency of sexual activities of at least once per week and comply with study related tests and procedures 6.
must give up any other EF enhancing treatment, including hormonal (T) replacement therapy with study entrance.

Exclusion Criteria

Previous surgery of penile fracture/ hypospadias/penile reconstructive surgery.
history of significant psychiatric disease/BPD 3.
untreated hypogonadism 4.
uncontrolled DM (HBA1c> 9%) 5.
patients using intra-cavernosal injection of vasoactive substances for ED 6.
developing priapism during before or during study period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The achievement of minimal clinically important difference	The achievement of minimal clinically important difference \| (MCID) in the International Index of Erectile Function Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment.
(MCID) in the International Index of Erectile Function âˆ’ Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment.	The achievement of minimal clinically important difference \| (MCID) in the International Index of Erectile Function Erectile Domain (IIEF-EF) from baseline to 6 months after final treatment.

Secondary Outcome Measures

Name	Time	Method
Sexual Encounter Profile SEP Questions 2 & 3,	EHS (erectile hardness score) increase of one point at 3 & 6 month

Trial Locations

Locations (1): AIIMS RAIPUR
🇮🇳
Raipur, CHHATTISGARH, India
AIIMS RAIPUR
🇮🇳Raipur, CHHATTISGARH, India
SATYADEO SHARMA
Principal investigator
7772967744
satyadeo2004@gmail.com