Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06433596
Other study ID # PRP-SW-03
Secondary ID 2022-002985-34
Status Recruiting
Phase N/A
First received
Last updated
Start date May 6, 2024
Est. completion date December 2026

Study information

Verified date May 2024
Source Elexial Research Limited
Contact Carolina Sandoval, Master
Phone 0057 31339208916
Email csandoval@bostonmedical.com.co
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild to moderate erectile dysfunction, measured as improvement in the IIEF-EF questionnaire score. Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups: - G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves - G2 - combined therapy: Autologous PRP + focal shock waves - G3 - placebo control: Placebo PRP + placebo shock waves - G4 - shock waves: PRP placebo + shock waves 116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above. The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date December 2026
Est. primary completion date June 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Men over 18 years of age. 2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse. 3. Baseline score of the IIEF-EF questionnaire between 11 and 21. 4. Stable heterosexual relationship of at least 6 months. 5. Commitment to have at least 3 vaginal sexual relations per month after completing treatment. 6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion. 7. A patient who agrees to voluntarily enter the study by signing an informed consent. Exclusion Criteria: 1. Score of 4 on the EHS scale. 2. Patients with an international normalized ratio (INR) greater than 3. 3. Patients with sickle cell anemia. 4. Patients with clinical suspicion of hypogonadism (ADAM positive). 5. Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency. 6. Active bladder, prostate, or colon cancer. 7. Radical prostatectomy or other radical pelvic surgery. 8. History of pelvic radiotherapy. 9. Spinal cord injury or other neurological disease associated with erectile dysfunction. 10. Penile anatomical dysfunction, penile implant. 11. Platelet diseases or coagulation disorders. 12. Treatment with oral anticoagulants. 13. Platelet count outside the normal range (150 to 400 Ă— 109/L). 14. Patients with active infections or lesions of the penis or pubic area. 15. Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics). 16. Patients with erectile dysfunction of psychological origin. 17. Abuse of psychoactive substances (including alcohol). 18. Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls. 19. Inability to attend therapies and controls.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Shock waves therapy
6 sessions of focal shock waves, 1 per week
Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Sham shock waves therapy
6 sessions of sham shock waves, 1 per week

Locations

Country Name City State
Spain Boston Medical Group Spain S.L.U Madrid

Sponsors (2)

Lead Sponsor Collaborator
Elexial Research Limited Boston Medical Group

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in IIEF-EF score Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment) From enrollment to the third month of follow-up at 21 weeks
Secondary Change in IIEF-EF score 1- month follow-up Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13 From enrollment to the first month of follow-up at 13 weeks
Secondary Change in IIEF-EF score 6 months follow-up Change in IIEF-EF score between baseline measurement and measurement at week 33 From enrollment to the sixth month of follow-up at 33 weeks
Secondary Minimum clinically significant difference Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points) From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary Change in Erection Hardness Score (EHS) Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33 From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary Ability to penetrate Proportion of patients who accomplish to penetrate after treatment, evaluated by the change in the EHS from 1 or 2 at baseline to 3 or 4 in weeks 13, 21 and 33. From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary Quality of sexual life Change in the score of the sexual quality of life questionnaire (SLQQ) between the baseline measurement and the measurement at weeks 13, 21 and 33. From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary Global assessment Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33. From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Secondary Adverse events incidence Incidence of PRP-related adverse events during the study From the first intervention to end of follow-up at 33 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4