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

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219785
• Other study ID #: Pro00037405
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: The Methodist Hospital Research Institute
• Contact: Manuel Villarreal
• Phone: 3462386122
• Email: mvillarreal2[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

Device:
• Low-Intensity Shockwave therapy (LiSWT)
Participants will receive once-a-week LiSWT 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.

Locations

Country	Name	City	State
United States	Houston Methodist	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.	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.	4 months
Primary	To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.	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.	4 months
Secondary	To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.	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.	4 months
Secondary	To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.	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.	4 months