Status:
ACTIVE_NOT_RECRUITING
Low Intensity Shockwave Therapy for Erectile Dysfunction
Lead Sponsor:
University of Virginia
Conditions:
Erectile Dysfunction
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
30-80 years
Phase:
NA
Brief Summary
Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Socie...
Detailed Description
It is estimated that about 1 in 10 adult males suffer from erectile dysfunction (ED) on a long-term basis. Oral therapies, including PDE5I, may be considered first-line therapies for the majority of p...
Eligibility Criteria
Inclusion
- The patient must be willing and able to provide informed consent.
- The patient is a male between \>30 and \<80 years of age.
- PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 2 weeks before baseline IIEF.
- Baseline IIEF-EF score ≥ 8 and ≤21. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF.
- Testosterone level \> 300 ng/dL. This includes patients on therapeutic testosterone therapy.
- If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment.
- Men who have undergone radical prostatectomy ≥ 12 months ago
- Men who have undergone radiation therapy, either brachytherapy or external bean therapy ≥ 12 months ago
Exclusion
- History of extensive pelvic surgery ever.
- Past radiation therapy of the pelvic region within 12 months prior to enrollment.
- Recovering from any non-prostate related cancer within 12 months prior to enrollment.
- Neurological disease which affects erectile function at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level \<300 within 3 month prior to enrollment.
- HgbA1C level \> 7.5% within 3 month prior to enrollment.
- History of spinal cord injury.
- Recovering from any non-prostate cancer malignancy within 12 months prior to enrollment.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 9 2025
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04434352
Start Date
June 1 2020
End Date
January 9 2025
Last Update
May 10 2024
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908