Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy
NCT06152146 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-05-22
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
Conditions
Interventions
- DEVICE
-
Shockwave Therapy
Each therapy session will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base)
- OTHER
-
SHAM shockwave therapy
Each therapy session, lasting about 20 minutes, will deliver 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base)
Sponsors & Collaborators
-
University of Miami
lead OTHER
Principal Investigators
-
Ranjith Ramasamy, MD · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-08
- Primary Completion
- 2025-12-15
- Completion
- 2026-06-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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