Low Intensity Shockwave Therapy for Erectile Dysfunction
Erectile Dysfunction, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Following Radiation Therapy
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Baseline Erectile Dysfunction
Erectile Dysfunction-Penile Rehabilitation
Erectile Dysfunction Post-Prostate Cancer Treatment
The first arm of the study will be those men with erectile dysfunction as defined by IIEF score. These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM score and EHS score. Each questionnaire is described in the trial description with a higher score indicating improved function.
The second population of patients will be those who are planning to undergo treatment for prostate cancer. In a similar manner, men will be randomized to either the Sham or active treatment groups. Men will be treated prior to undergoing definitive treatment for prostate cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to prostate cancer treatment.
The third population of patients will be those who have undergone treatment for prostate cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone prostatectomy or radiation therapy. Again, there will be a sham and treatment group.