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 range
18 Years
Sex
MALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in IIEF-EF score
Timeframe: From enrollment to the third month of follow-up at 21 weeks