Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Spain
Boston Medical Group Spain S.L.U
RECRUITING
Madrid
Contact Information
Primary
Carolina Sandoval, Master
csandoval@bostonmedical.com.co
0057 31339208916
Backup
Héctor Corredor, MD
hcorredor@bostonmedical.com.co
0057 3174317162
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 116
Treatments
Experimental: Autologous PRP
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Experimental: Combined therapy
3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Placebo_comparator: Placebo control
3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Active_comparator: Shock waves
3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Medical Group
Leads: Elexial Research Limited

This content was sourced from clinicaltrials.gov