Investigating the efficacy of intracavernosal injection of platelet-rich plasma (PRP) in the treatment of erectile dysfunction in diabetic patients resistent to phosphodiesterase type 5 (PDE-5) inhibitors: a randomized controlled clinical trial
Investigating the efficacy of intracavernosal injection of platelet-rich plasma (PRP) in the treatment of erectile dysfunction in diabetic patients with oral treatments-resistent to
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 58 patients. Individual randomization was done from the graphpad site and with the sealed envelope tool.
Settings and conduct
The study will be conducted in the urology outpatient operating room at the Razi Hospital in Rasht. In this three-blind clinical trial patients, allocators of samples to groups, and evaluators are not aware of the study group. The patients are classified into two groups A and B via sealed envelopes by one of the colleagues who does not interfere in the study implementation process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: More than 6 months have passed since erectile dysfunction, Have at least 10 years of diabets, Having persistent sex in last 3 months
Exclusion criteria: History of psychological disorders, History of using energy therapy in the last month, History of radiation, penile surgery or having penile prosthesis, History of trauma and fracture of pelvic, History of priapism, penile fracture and Peyronie's, History of using anti-androgen and selective serotonin reuptake inhibitors
Intervention groups
Intervention group: Taking 30ml of blood from the patient to receive platelet-rich plasma (PRP), injecting 6cc of PRP through intracavernosal (3cc in each corpora cavernosa), 3 injections with an interval of 15 days
Main outcome variables
Erectile function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100817004582N9
Registration date:2024-07-05, 1403/04/15
Registration timing:prospective
Last update:2024-07-05, 1403/04/15
Update count:0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of intracavernosal injection of platelet-rich plasma (PRP) in the treatment of erectile dysfunction in diabetic patients resistent to phosphodiesterase type 5 (PDE-5) inhibitors: a randomized controlled clinical trial
Public title
Investigating the efficacy of intracavernosal injection of platelet-rich plasma (PRP) in the treatment of erectile dysfunction in diabetic patients with oral treatments-resistent to
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-responder to PDE5Is
Having score at least 21 in IIEF questionnair
More than 6 months have passed since erectile dysfunction
Have at least 10 years of diabets history
Having persistent sex in last 3 months
Exclusion criteria:
History of using PDE5Is in the last month
History of psychological disorders and use of related drugs for its treatment
History ofusing energy therapy for erectile dysfunction in the last month
History of radiation or penile surgery or having penile prosthesis
History of trauma, fracture and pelvic surgery
History of priapism, penile fracture and Peyronie's
History of using anti-androgen and selective serotonin reuptake inhibitors (SSRIs)
Presence of active infection evidence in the injected area
Abnormal morning testosterone levels (lower than 200 and above 1197)
Age
From 30 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 4 with a ratio of 1 to 1 is done individually by a sealed envelope with a random sequence (SNOSE).
Blinding (investigator's opinion)
Double blinded
Blinding description
Blood sampling and preparation of injection syringes are done by a skilled and trained colleague. The syringes are completely covered by nontranslusence adhesive tape. The researcher responsible for the injection and the patient do not know the contents of the syringe.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice chancellor of research and technology, Siyadati Street, Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2024-05-08, 1403/02/19
Ethics committee reference number
IR.GUMS.REC.1403.055
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
Male erect
ICD-10 code description
N52.9
Primary outcomes
1
Description
Erectile function
Timepoint
Before intervention, 1, 3 and 6 months after last injection
Method of measurement
The International Index of Erectile Dysfunction (IIEF) questionnaire
2
Description
Erection quality
Timepoint
Before intervention, 1, 3 and 6 months after last injection
Method of measurement
Erectile Hardness Score (EHS) index
Secondary outcomes
1
Description
Patient satisfaction score of treatment
Timepoint
1, 3 and 6 months after last injection
Method of measurement
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
Intervention groups
1
Description
Intervention group: Taking 30 ml of blood from the patient to receive platelet-rich plasma by centrifugation through a standard device, injecting 6 cc of platelet-rich plasma received through intracavernosal (3 cc in each corpora cavernosa), 3 injections with an interval of 15 days
Category
Treatment - Drugs
2
Description
Control group: Taking 30 ml of blood from the patient, injecting 6 cc of normal saline through intracavernosal (3 cc in each corpora cavernosa), 3 injections with an interval of 15 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Educational Hospital
Full name of responsible person
Ali Hamidi Madani
Street address
Razi Hospital, Modafean-e-Salamat street
City
Rasht
Province
Guilan
Postal code
414489565
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address
https://urc.gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ramiyar Farzan
Street address
Namjoo street, Vice Chancellor of Research and Technology
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 6394
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Amir Hossein Shahabi
Position
Resident of Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Razi Hospital, Modafean-e-Salamat Street
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3352 5259
Email
urc1384@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Ali Hamidi Madani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Razi Hospital, Modafean-e-Salamat Street
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3352 5259
Email
a.hamidimadani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samandh Esmaeili
Position
Researcher of Urology Research Center
Latest degree
Master
Other areas of specialty/work
Urology
Street address
Razi Hospital, Modafean-e-Salamat Street
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3352 5259
Email
samaneh_815@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available