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

NCT06219785 | Terminated FDA Device

• 1 other identifier: Pro00037405
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.

  4 months

• To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.

  4 months

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Device: Low-Intensity Shockwave therapy (LiSWT)

Control

SHAM COMPARATOR

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

Device: Low-Intensity Shockwave therapy (LiSWT)

Interventions

Low-Intensity Shockwave therapy (LiSWT) DEVICE

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.

Active; Control

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

Location

Study Officials

• Brian J. Miles, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Brian J Miles MD

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: January 23, 2024
• Study Start: January 10, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

US (1)