Erectile Dysfunction
Conditions
Keywords
Platelet-Rich Plasma, Erectile Function, Low-Intensity Extracorporeal Shock Wave Therapy, Penile Hemodynamics, Regenerative Therapy
Brief summary
Erectile dysfunction is a common condition that may result from vascular, neurological, hormonal, psychological, or medication-related factors. Platelet-rich plasma (PRP) and low-intensity extracorporeal shock wave therapy (Li-ESWT) are regenerative treatment approaches that may improve erectile function through mechanisms involving angiogenesis, tissue repair, and improvement of penile vascular function. This randomized prospective study will compare the efficacy and safety of PRP injection alone with combined PRP injection and Li-ESWT in men with erectile dysfunction. A total of 80 participants will be randomly assigned to two groups. One group will receive PRP injections alone, while the other group will receive PRP injections combined with Li-ESWT. Participants will be followed after treatment to assess changes in erectile function, erection hardness, penile blood flow, patient satisfaction, and treatment-related adverse events. The study hypothesis is that adding Li-ESWT to PRP therapy will result in greater improvement in erectile function than PRP therapy alone.
Interventions
BIOLOGICALPlatelet-Rich Plasma
Autologous platelet-rich plasma will be prepared from approximately 20 mL of the participant's blood using a double-spin centrifugation method, targeting a platelet concentration of 3-5 times baseline. PRP will be administered by intracavernosal injection at two sites, with three injections given over 6 weeks at 2-week intervals.
Low-intensity extracorporeal shock wave therapy will be delivered to the penile shaft with or without treatment of the crura using an energy density of 0.15 mJ/mm² and 2,000 shocks per session. Participants will receive six sessions over 6 weeks, at a frequency of one session per week.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in parallel to receive either platelet-rich plasma injections alone or platelet-rich plasma injections combined with low-intensity extracorporeal shock wave therapy.
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male participants aged 30-65 years. * Diagnosis of erectile dysfunction for at least 3 months. * Mild to moderate erectile dysfunction, defined by an International Index of Erectile Function-5 (IIEF-5) score of 8-21. * In a stable heterosexual relationship for at least 6 months. * Sexually active, with at least one sexual attempt per week.
Exclusion criteria
* Severe erectile dysfunction, defined as IIEF-5 score \<8. * Primary psychogenic erectile dysfunction based on clinical history with or without psychosexual assessment. * Anatomical penile abnormalities, including Peyronie's disease. * History of radical pelvic surgery or pelvic radiotherapy. * Uncontrolled diabetes mellitus, defined as HbA1c \>9%. * Uncontrolled hypertension, defined as blood pressure \>160/100 mmHg. * Recent myocardial infarction or stroke within the previous 6 months. * Unstable angina. * New York Heart Association class III-IV heart failure. * Severe hepatic impairment. * Severe renal impairment. * Hypogonadism, defined as total testosterone \<300 ng/dL. * Hyperprolactinemia. * Untreated thyroid disease. * Current use of nitrates or nitric oxide donors. * Current use of alpha-blockers, unless the participant is on a stable low dose. * Current use of other phosphodiesterase type 5 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score | Baseline and 4, 12, and 24 weeks after intervention | Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5), a 5-item self-administered questionnaire assessing erectile function and intercourse-related sexual performance. Each item is scored from 1 to 5, giving a total score ranging from 5 to 25, with higher scores indicating better erectile function. Scores are interpreted as: 22-25, no erectile dysfunction; 17-21, mild erectile dysfunction; 12-16, mild-to-moderate erectile dysfunction; 8-11, moderate erectile dysfunction; and 5-7, severe erectile dysfunction. Change from baseline in the total IIEF-5 score will be compared between the treatment groups. |
| Change From Baseline in Erection Hardness Score (EHS) | Baseline and 4, 12, and 24 weeks after intervention | Erection hardness will be assessed using the Erection Hardness Score (EHS), a single-item scale ranging from 0 to 4, with higher scores indicating greater erection rigidity. Scores are defined as follows: 0, penis does not enlarge; 1, penis is larger but not hard; 2, penis is hard but not hard enough for penetration; 3, penis is hard enough for penetration but not completely rigid; and 4, penis is completely hard and fully rigid. Change from baseline in the EHS will be compared between the treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Penile Peak Systolic Velocity | Baseline and 4, 12, and 24 weeks after intervention | Peak systolic velocity (PSV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile arterial blood flow following treatment. |
| Change From Baseline in Penile End-Diastolic Velocity | Baseline and 4, 12, and 24 weeks after intervention | End-diastolic velocity (EDV) will be measured using penile duplex Doppler ultrasonography to assess changes in penile hemodynamics following treatment. |
| Patient Satisfaction With Treatment | 4, 12, and 24 weeks after intervention | Patient satisfaction with treatment will be assessed using a 5-point Likert scale. Participants will rate their overall satisfaction as: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater treatment satisfaction. Satisfaction scores will be compared between the two treatment groups. |
Countries
Egypt
Contacts
CONTACTTamer A Diab, MD
Outcome results
None listed