Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostate… (NCT06152146) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
Stopped: Study submission was discarded with the IRB and no longer moving forward
United States0Started 2024-07-08
Plain-language 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
Who can participate
Age range40 Years – 75 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕
What they're measuring
1
Change in number of participants reporting on Penetrative Intercourse
Timeframe: Baseline to 6 months and Baseline to 12 months.