Clinical trial NCT05787769: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction Following Radiation Therapy
Phosphodiesterase Inhibitor Adverse Reaction
Platelet- Rich Plasma (PRP)
Keywords: Erectile Dysfunction , Phosphodiesterase Inhibitor Adverse Reaction, platelet- rich plasma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 96
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: efficacy of intracavernosal injections of platelet-rich plasma (PRP) in patients Erectile Dysfunction.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura urology and nephrology center
state: Outside U.S./Canada
Study officials:
affiliation: Mansoura University
name: Ahmed El-assmy
role: STUDY_DIRECTOR
References: