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A Randomized Trial to Evaluate Efficacy and Safety of Intracavernosal Injection of Platelet-Rich Plasma Versus Phosphodiesterase Type-5 Inhibitors for Treatment of Erectile Dysfunction.

Primary Purpose

Erectile Dysfunction Following Radiation Therapy, Phosphodiesterase Inhibitor Adverse Reaction, Platelet- Rich Plasma (PRP)

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
P shot arm ( Autologous Platelet Rich Plasma)
PDE5i arm
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction Following Radiation Therapy focused on measuring Erectile Dysfunction , Phosphodiesterase Inhibitor Adverse Reaction, platelet- rich plasma

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 1) Signed an ethics committee-reviewed and approved informed consent form. 2) Subjects must meet all inclusion criteria to be eligible for study enrollment. 3) Men between 30 and 75 years old, 4) Sexually active in a stable, heterosexual relationship of at least six months duration. 5) ED for at least 6 months with an IIEF-EF between 5 and 16 points, inclusive. 6) ED of vascular origin. 7) Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS). 8) Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.). 9) Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions. Exclusion Criteria: 1) Refuse to complete study requirements. 2) Psychogenic ED as determined by study investigator. 3) ED of neurogenic origin (radical cystectomy, radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, DM is not included unless documented diabetic neuropathy). 4) Previous penile surgery of any kind (except circumcision, frenuloplasty and condyloma removal), such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication, grafting. 5) Previous history of penile fracture, Peyronie's disease or priapism. 6) Previous radiation to pelvis. 7) History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated. 8) Major hematologic, renal, or hepatic abnormalities. 9) Severe decompensated cardiac, CNS or vascular insufficiency. 10) Poorly controlled hypertension or DM (HbA1c >12%). 11) Neoplasm of any origin in active treatment or active progression or recovering from cancer within 12 months prior to enrollment. 12) History of alcohol abuse or drug. 13) Treatment with oral anticoagulants, antiandrogens or nitrates. 14) Thrombopenia less than 100 x 103 / L. 15) Hemoglobin <10g/dl. 16) Poor venous access or any other circumstance that preclude an apheresis procedure. 17) Sexually inactive in recent months. 18) participation in another study that may interfere with the results or conclusions of this study.

Sites / Locations

  • Mansoura urology and nephrology center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

P shot arm

PDE5i arm

Arm Description

Drug: Autologous Platelet Rich Plasma + placebo tab Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.

Drug: Tadalafil + placebo injection Patients will be treated by tadalafil 5 mg tablet daily in addition to four Tadalafil 5 mg tablet 3 hours before intercourse on demand in addition to placebo injection. Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.

Outcomes

Primary Outcome Measures

efficacy of intracavernosal injections of platelet-rich plasma (PRP) in patients Erectile Dysfunction.
assessed by the proportion of patients attaining minimal clinically important difference in the international index of erectile function - erection dpmain.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05787769
Brief Title
A Randomized Trial to Evaluate Efficacy and Safety of Intracavernosal Injection of Platelet-Rich Plasma Versus Phosphodiesterase Type-5 Inhibitors for Treatment of Erectile Dysfunction.
Official Title
A Randomized Trial to Evaluate Efficacy and Safety of Intracavernosal Injection of Platelet-Rich Plasma Versus Phosphodiesterase Type-5 Inhibitors for Treatment of Erectile Dysfunction.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 25, 2025 (Anticipated)
Study Completion Date
January 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the efficacy and safety of intracavernosal injection of PRP in patients with moderate to severe ED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Following Radiation Therapy, Phosphodiesterase Inhibitor Adverse Reaction, Platelet- Rich Plasma (PRP)
Keywords
Erectile Dysfunction , Phosphodiesterase Inhibitor Adverse Reaction, platelet- rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P shot arm
Arm Type
Active Comparator
Arm Description
Drug: Autologous Platelet Rich Plasma + placebo tab Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
Arm Title
PDE5i arm
Arm Type
Active Comparator
Arm Description
Drug: Tadalafil + placebo injection Patients will be treated by tadalafil 5 mg tablet daily in addition to four Tadalafil 5 mg tablet 3 hours before intercourse on demand in addition to placebo injection. Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
Intervention Type
Drug
Intervention Name(s)
P shot arm ( Autologous Platelet Rich Plasma)
Other Intervention Name(s)
Autologous Platelet Rich Plasma
Intervention Description
Autologous Platelet Rich Plasma + placebo tab Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum
Intervention Type
Drug
Intervention Name(s)
PDE5i arm
Intervention Description
Patients will be treated by tadalafil 5 mg tablet daily in addition to four Tadalafil 5 mg tablet 3 hours before intercourse on demand in addition to placebo injection. Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
Primary Outcome Measure Information:
Title
efficacy of intracavernosal injections of platelet-rich plasma (PRP) in patients Erectile Dysfunction.
Description
assessed by the proportion of patients attaining minimal clinically important difference in the international index of erectile function - erection dpmain.
Time Frame
6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Signed an ethics committee-reviewed and approved informed consent form. 2) Subjects must meet all inclusion criteria to be eligible for study enrollment. 3) Men between 30 and 75 years old, 4) Sexually active in a stable, heterosexual relationship of at least six months duration. 5) ED for at least 6 months with an IIEF-EF between 5 and 16 points, inclusive. 6) ED of vascular origin. 7) Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS). 8) Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.). 9) Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions. Exclusion Criteria: 1) Refuse to complete study requirements. 2) Psychogenic ED as determined by study investigator. 3) ED of neurogenic origin (radical cystectomy, radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, DM is not included unless documented diabetic neuropathy). 4) Previous penile surgery of any kind (except circumcision, frenuloplasty and condyloma removal), such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication, grafting. 5) Previous history of penile fracture, Peyronie's disease or priapism. 6) Previous radiation to pelvis. 7) History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated. 8) Major hematologic, renal, or hepatic abnormalities. 9) Severe decompensated cardiac, CNS or vascular insufficiency. 10) Poorly controlled hypertension or DM (HbA1c >12%). 11) Neoplasm of any origin in active treatment or active progression or recovering from cancer within 12 months prior to enrollment. 12) History of alcohol abuse or drug. 13) Treatment with oral anticoagulants, antiandrogens or nitrates. 14) Thrombopenia less than 100 x 103 / L. 15) Hemoglobin <10g/dl. 16) Poor venous access or any other circumstance that preclude an apheresis procedure. 17) Sexually inactive in recent months. 18) participation in another study that may interfere with the results or conclusions of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed El-assmy
Organizational Affiliation
Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura urology and nephrology center
City
Mansoura
State/Province
Outside U.S./Canada
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

A Randomized Trial to Evaluate Efficacy and Safety of Intracavernosal Injection of Platelet-Rich Plasma Versus Phosphodiesterase Type-5 Inhibitors for Treatment of Erectile Dysfunction.

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