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NCT06152146 | WITHDRAWN | Erectile Dysfunction

Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
Sponsor:

University of Miami

Information provided by (Responsible Party):

Russell Saltzman

Brief Summary:

Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy

Condition or disease

Erectile Dysfunction

Intervention/treatment

Shockwave Therapy

SHAM shockwave therapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 0 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL
Actual Study Start Date : 2024-07-08
Estimated Primary Completion Date : 2025-12-15
Estimated Study Completion Date : 2026-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Be willing and able to provide informed consent.
  • 2. Be male
  • 3. Be ≥ 40 and ≤ 75 years of age (inclusive).
  • 4. Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
  • 5. Be at least six weeks post radical prostatectomy.
  • 6. Be in a stable sexual relationship for over 3 months prior to enrollment.
  • 7. Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
  • 8. Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
  • 9. Have undetectable PSA value at the time of enrollment
Exclusion Criteria
  • 1. Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.
  • 2. Be under judicial protection (prison or custody).
  • 3. Be an adult under guardianship.
  • 4. Refuse to sign the informed consent.
  • 5. Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
  • 6. Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
  • 7. Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
  • 8. Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
  • 9. Have a Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator).
  • 10. Have an anatomical malformation of the penis, including Peyronie's disease.
  • 11. Have testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
  • 12. Be using blood thinners with international normalized ratio (INR) to be \> 3.
  • 13. Have received shockwave therapy for at least 6 months before enrollment.
  • 14. Have detectable PSA value after the radical prostatectomy.
  • 15. Require radiation therapy after radical prostatectomy.
  • 16. Require hormonal therapy after radical prostatectomy.
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy

Location Details

NCT06152146

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How to Participate

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Locations

Not yet recruiting

United States, Florida

Desai Sethi Urology Institute - University of Miami, Miller School of Medicine

Miami, Florida, United States, 33136