Status:
TERMINATED
Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
45-70 years
Phase:
NA
Brief Summary
This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.
Detailed Description
Participants will be randomized to the active treatment group or the control/placebo group. All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to ...
Eligibility Criteria
Inclusion
- Men age 45-70 who had robotic prostatectomy within 6 to 18 months
- Documented nerve sparing during radical prostatectomy procedure
- Mild to moderate ED after prostatectomy
- IIEF score \> 18 before surgery
- Testosterone level \> 300 mg/dl post-surgery
- Sexually active
Exclusion
- Prior penile surgery
- Lesions or active infections on the penis or perineum
- Anatomical abnormalities in the genitalia or pelvic region
- Unwilling to remove piercing from genital region
- Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
- Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
- Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
- Any other condition that would prevent the patient from completing the study, as judged by the PI
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06219785
Start Date
January 10 2024
End Date
October 1 2024
Last Update
October 8 2024
Active Locations (1)
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1
Houston Methodist
Houston, Texas, United States, 77030