Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunction Due to General Medical Condition, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunctions
Conditions
Brief summary
Patients are randomized into 2 groups (A and B), subsequently group A is subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP while group B is subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg. After 4 (four) weeks the groups will be crossed, so group A will be subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg while group B will be subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP.
Interventions
DRUGPRP injection
3 ML OF PRP
1 ML
Sponsors
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe erectile dysfunction (IIEF-5 score below 17) * Patients previously treated with first- and second-line therapies for ED * Patients who have undergone radical pelvic surgery with nerve sparing * Good pharmacological blood pressure control * Well-controlled diabetes on medication * Current or former smokers * Good renal function even with the use of medications * Well-controlled hypertriglyceridemia and/or hypercholesterolemia even with the use of medications * BMI less than or equal to 35 * Normal levels of FSH, LH, PRL, Total Testosterone, and TSH
Exclusion criteria
* Patients on antidepressant, anxiolytic, sedative, or antipsychotic medications. * Consumers of more than 500 g of alcohol per day. * BMI greater than 35 * Altered levels of FSH, LH, PRL, Total Testosterone, and TSH.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in erectile function | 24 WEEKS | Change in erectile function defined as the % of patients in each group achieving MCID in the IIEF-EF domain from baseline to 24 weeks (i.e. 12 weeks after the end of full treatment): * MCID (Minimal clinically important differences) is based on the severity of ED at baseline as: * Improvement of 5 or points more in IIEF score for patients with moderate ED (8-11) at baseline * Improvement of 2 or more points in IIEF score for patients with severe ED (5-7) at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP | 24 WEEKS | MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as: * An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline * An improvement of 2 or more points in the IIEF score for patients with severe ED (5-7) at baseline |
| The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin | 24 WEEKS | MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as: * An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline * An improvement of 2 or more points |
| The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group. | 24 WEEKS | The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group. |
| SEP | 24 WEEKS | Change in SEP: * Response to questions 2 and 3 (SEP-Q2: Were you able to insert your penis into your partner's vagina? / SEP-Q3: Did your erection last long enough to allow you to have successful intercourse?) * Change from baseline (= YES response) o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) |
| GAQ | 24 WEEKS | Response to GAQ questions 1 and 2 (GAQ-Q1: Has the treatment you are taking improved your erectile function? / GAQ-Q2: If yes, has the treatment improved your ability to engage in sexual activity?) Change at T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Change from baseline (= YES response) |
| QEQ | 24 WEEKS | At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Improvement of 2 or more in the score |
| EHS | 24 WEEKS | Time frame: change from baseline and at 8 weeks, 16 weeks, and 24 weeks Any value above 0 (0 = The penis does not enlarge) |
| Change in TSS between PRP vs. prostaglandins | 3 months after the end of the complete treatment | Change in TSS between PRP vs. prostaglandins at T3 (3 months after the end of the complete treatment) |
| Change in SHIM | 24 WEEKS | Change in SHIM * At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Improvement of 2 or more points in the score |
| ECDPD - Peak Systolic Velocity (PSV) | 24 WEEKS | ECDPD - Peak Systolic Velocity (PSV): * To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Recording of arterial penile velocity (cm/s) o Improvement in cm/s (any \> 30 cm/s) |
| ECDPD - Resistance Index (RI) | 24 WEEKS | ECDPD - Resistance Index (RI): * To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Penile vascular resistance index (ratio) o Improvement (any increase up to the normal value - 0.9) |
| ECDPD - End-Diastolic Velocity (EDV) | 24 WEEKS | ECDPD - End-Diastolic Velocity (EDV): * To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) * Recording of residual flow in a vessel at the end of the diastolic phase (cm/s) * Improvement in cm/s (any decrease in cm/s) |
| Adverse events | 24 WEEKS | Adverse events: Number of participants who experienced treatment-related adverse events. Defined as: skin reaction (e.g., swelling, erythema, and warmth), discomfort at the injection site, penile pain, change in penile appearance, new sexual problems, and any systemic reaction observed by investigators or concerns expressed by patients o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) |
| Change in EDITS between PRP vs. prostaglandins | At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle) | At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle) |
Countries
Italy
Outcome results
None listed