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

Not Applicable

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Control	Low-Intensity Shockwave therapy (LiSWT)	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
Active	Low-Intensity Shockwave therapy (LiSWT)	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

Primary Outcome Measures

Name	Time	Method
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.	4 months	The Erection Hardness Score is a self-reported tool that measures the hardness of an erection. It involves a scale report from 0 to 4, 4 being the best quality of erection.
To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.	4 months	The International Index of Erectile Function is a multidimensional scale that can be used to evaluate ED. It addresses the most relevant aspects of male sexual function. It involves five questions with a scale report from 0 to 5, 5 being the best value.

Secondary Outcome Measures

Name	Time	Method
To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.	4 months	The second hemodynamic parameter commonly used in Duplex Doppler Ultrasound is the Resistive Index. A value greater than 0.90% would indicate a state of normality. The higher the parameters, the better the response to the therapy.
To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.	4 months	A hemodynamic parameter commonly used in Duplex Doppler Ultrasound is Peak systolic velocity. A value of 30 cm/s or greater indicates arterial competence. The higher the parameters, the better the response to the therapy.