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CTRI Number  CTRI/2023/09/058110 [Registered on: 29/09/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patient own body tissue(platelet rich plasma)]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Intracavernosal injection of platelet rich plasma for treatment of erectile dysfunction  
Scientific Title of Study   Use of intracavernosal injection of autologous platelet rich plasma for the treatment of mild to moderate erectile dysfunction: A placebo controlled, parallel group, double blind randomized clinical trail 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  satyadeo sharma 
Designation  Assistant professor urology 
Affiliation  All India Institute of Medical Sciences RAIPUR 
Address  Urology OPD, ground floor, c block, gate no. 4, All India Institute of Medical Sciences, AIIMS Raipur, Tatibandh

Raipur
CHHATTISGARH
492099
India 
Phone  7772967744  
Fax    
Email  satyadeo2004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  satyadeo sharma 
Designation  Assistant professor urology 
Affiliation  AIIMS RAIPUR 
Address  Urology OPD, ground floor, c block, tatibandh, All India Institute of Medical Sciences, AIIMS Raipur. chhattisgarh.

Raipur
CHHATTISGARH
492099
India 
Phone  7772967744  
Fax    
Email  satyadeo2004@gmail.com  
 
Details of Contact Person
Public Query  
Name  satyadeo sharma 
Designation  Assistant professor urology 
Affiliation  All India Institute of Medical Sciences RAIPUR 
Address  Urology OPD, ground floor, c block, tatibandh, AIIMS Raipur. chhattisgarh.

Raipur
CHHATTISGARH
492099
India 
Phone  7772967744  
Fax    
Email  satyadeo2004@gmail.com  
 
Source of Monetary or Material Support  
Intramural funded project from ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raipur 
Address  AIIMS RAIPUR, tatibandh, raipur, chhattisgarh. 492099 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SATYADEO SHARMA  AIIMS RAIPUR  DEPARTMENT OF UROLOGY AND RENAL TRANSPLANT UROLOGY OPD- ROOM NO 4, GROUND FLOOR C BLOCK. AIIMS TATIBANDH RAIPUR, CHHATTISGARH
Raipur
CHHATTISGARH 		 7772967744

satyadeo2004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N529||Male erectile dysfunction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  autologous platelet rich plasma  intracavernosal injection of autologous platelet rich plasma Two injections one month apart, followup of 3 month. total study duration one year. 
Comparator Agent  placebo  multivitamin in normal saline solution, intracavernosal injection Two injections one month apart, followup of 3 month. total study duration one year. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1. 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. 
 
ExclusionCriteria 
Details  1. Previous surgery of penile fracture/ hypospadias/penile reconstructive surgery. 2. 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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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. 		 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  
Outcome  TimePoints 
Sexual Encounter Profile SEP Questions 2 & 3,
EHS (erectile hardness score) increase of one point at 3 & 6 month
followup.
Change in doppler ultrasound parameters ( Time Frame: Baseline, Up to 29
weeks )
as well as safety of PRP injections (Incidence of adverse events
( Time Frame: 24 weeks ), were also evaluated. 		 exual Encounter Profile SEP Questions 2 & 3,
EHS (erectile hardness score) increase of one point at 3 & 6 month
followup.
Change in doppler ultrasound parameters ( Time Frame: Baseline, Up to 29
weeks )
as well as safety of PRP injections (Incidence of adverse events
( Time Frame: 24 weeks ), were also evaluated. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 patient’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.

 
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