Clinical trial NCT06219785: Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
Official title: Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 5
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Following completion of the 3-month follow-up visit, subjects will be unblinded. Subjects who received the Placebo/control treatment will be offered treatment using the active device applicator.
Primary purpose: TREATMENT

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 the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis.

Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.

Eligibility criteria: Inclusion Criteria:

1. Men age 45-70 who had robotic prostatectomy within 6 to 18 months
2. Documented nerve sparing during radical prostatectomy procedure
3. Mild to moderate ED after prostatectomy
4. IIEF score \> 18 before surgery
5. Testosterone level \> 300 mg/dl post-surgery
6. Sexually active

Exclusion Criteria:

1. Prior penile surgery
2. Lesions or active infections on the penis or perineum
3. Anatomical abnormalities in the genitalia or pelvic region
4. Unwilling to remove piercing from genital region
5. Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
6. Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
7. Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
8. Any other condition that would prevent the patient from completing the study, as judged by the PI

Primary outcomes:
measure: To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.
timeFrame: 4 months
measure: To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.
timeFrame: 4 months
Secondary outcomes:
measure: To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.
timeFrame: 4 months
measure: To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.
timeFrame: 4 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Brian J. Miles, MD
role: PRINCIPAL_INVESTIGATOR
References: