Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction

The Methodist Hospital Research Institute (TMHRI)

Status: Terminated

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Device: Low-Intensity Shockwave therapy (LiSWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06219785

Pro00037405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

5 participants in 2 patient groups

Active

Active Comparator group

Description:

1. Patient lies down with legs extended. 2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring. 3. Connect the headpiece to the ring. 4. Apply ultrasound gel for proper energy transmission on the shaft of the penis 5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis 6. Duration of the procedure: approximately 30 minutes

Treatment:

Device: Low-Intensity Shockwave therapy (LiSWT)

Control

Sham Comparator group

Description:

1. Patient lies down with legs extended. 2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring. 3. Connect the headpiece to the ring. 4. Apply ultrasound gel for proper energy transmission on the shaft of the penis 5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis 6. Duration of the procedure: approximately 30 minutes

Treatment:

Device: Low-Intensity Shockwave therapy (LiSWT)