Status:
WITHDRAWN
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
Lead Sponsor:
University of Miami
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40-75 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- Be willing and able to provide informed consent.
- Be male
- Be ≥ 40 and ≤ 75 years of age (inclusive).
- Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
- Be at least six weeks post radical prostatectomy.
- Be in a stable sexual relationship for over 3 months prior to enrollment.
- Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
- Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
- Have undetectable PSA value at the time of enrollment
Exclusion
- 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.
- Be under judicial protection (prison or custody).
- Be an adult under guardianship.
- Refuse to sign the informed consent.
- Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
- Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
- Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
- Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
- 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).
- Have an anatomical malformation of the penis, including Peyronie's disease.
- Have testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
- Be using blood thinners with international normalized ratio (INR) to be \> 3.
- Have received shockwave therapy for at least 6 months before enrollment.
- Have detectable PSA value after the radical prostatectomy.
- Require radiation therapy after radical prostatectomy.
- Require hormonal therapy after radical prostatectomy.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06152146
Start Date
July 8 2024
End Date
June 1 2026
Last Update
May 22 2024
Active Locations (1)
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1
Desai Sethi Urology Institute - University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136