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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Device: Low-Intensity Shockwave therapy (LiSWT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Villarreal; Phone Number: 3462386122; Email: mvillarreal2@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist
      • Principal Investigator: Brian Miles, MD
      • Contact: Manuel Villarreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Patient lies down with legs extended.; In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.; Connect the headpiece to the ring.; Apply ultrasound gel for proper energy transmission on the shaft of the penis; 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; Duration of the procedure: approximately 30 minutes	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.
Sham Comparator: Control; Patient lies down with legs extended.; In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring.; Connect the headpiece to the ring.; Apply ultrasound gel for proper energy transmission on the shaft of the penis; 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; Duration of the procedure: approximately 30 minutes	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Brian J. Miles, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: Pro00037405

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No