Autologous PRP and Focal Shock Waves for Erectile Dysfunction (NCT06433596) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Autologous PRP and Focal Shock Waves for Erectile Dysfunction
Spain116 participantsStarted 2024-05-06
Plain-language summary
The goal of this clinical trial is to learn if Platelet-rich plasma (PRP) combined with Shock-wave therapy (SWT) works to treat moderate or mild to moderate erectile dysfunction. It will also learn about the safety of this combined therapy.
The main questions it aims to answer are:
* Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction?
* What medical problems do participants have when receiving Combined therapy PRP + SWT?
Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction.
Participants will:
* Take a lab test to evaluate their platelets
* Answer some questionnaires to assess your erectile function
* Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks
* Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men over 18 years of age.
✓. Erectile dysfunction present for more than 3 months in more than 50% of intercourse.
✓. Baseline score of the IIEF-EF questionnaire between 11 and 21.
✓. Stable heterosexual relationship of at least 6 months.
✓. Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
✓. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
✓. A patient who agrees to voluntarily enter the study by signing an informed consent.
Exclusion criteria
✕. Score of 4 on the EHS scale.
✕. Patients with an international normalized ratio (INR) greater than 3.
✕. Patients with sickle cell anemia.
What they're measuring
1
Change in IIEF-EF score
Timeframe: From enrollment to the third month of follow-up at 21 weeks