Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy

NCT ID: NCT06152146

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2026-06-01

Brief Summary

Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SWT group

Participants randomized to the treatment group will receive nine (9) shockwave sessions in total: one (1) shockwave session once per week for four (4) weeks, followed by one (1) shockwave session once per month (30±7 days) for the next five (5) months. 1,440 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) for a total of 12,960 shocks. Participants will be in this group for up to 6 months.

Group Type: ACTIVE_COMPARATOR

Shockwave Therapy

Intervention Type: DEVICE

Each therapy session will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base)

SHAM group

Participants randomized to the sham (control) group will have nine (9) sham therapy sessions in total: one (1) sham session once per week for four (4) weeks, followed by one (1) sham session once per month (30±7 days) for the next five (5) months. The shockwave machine will be set to deliver 1,440 shock treatments, but a barrier will be placed around the shockwave probe to ensure that no shockwaves are delivered. Participants will be in this group for up to 6 months.

Group Type: PLACEBO_COMPARATOR

SHAM shockwave therapy

Intervention Type: OTHER

Each therapy session, lasting about 20 minutes, will deliver 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base)

Interventions

Shockwave Therapy

Each therapy session will last about 20 minutes, during which 1,440 shockwaves will be applied to the penis via the left and right crus (shaft near the base)

Intervention Type: DEVICE

SHAM shockwave therapy

Each therapy session, lasting about 20 minutes, will deliver 1440 SHAM shockwave therapy applied to the penis via the left and right crus (shaft near the base)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Be willing and able to provide informed consent.

2. Be male

3. Be ≥ 40 and ≤ 75 years of age (inclusive).

4. Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)

5. Be at least six weeks post radical prostatectomy.

6. Be in a stable sexual relationship for over 3 months prior to enrollment.

7. Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.

8. Have an HbA1c level ≤ 7% within 3 months prior to enrollment.

9. Have undetectable PSA value at the time of enrollment

Exclusion Criteria

1. Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.

2. Be under judicial protection (prison or custody).

3. Be an adult under guardianship.

4. Refuse to sign the informed consent.

5. Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery

6. Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.

7. Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)

8. Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).

9. Have a Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator).

10. Have an anatomical malformation of the penis, including Peyronie's disease.

11. Have testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.

12. Be using blood thinners with international normalized ratio (INR) to be > 3.

13. Have received shockwave therapy for at least 6 months before enrollment.

14. Have detectable PSA value after the radical prostatectomy.

15. Require radiation therapy after radical prostatectomy.

16. Require hormonal therapy after radical prostatectomy.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Russell Saltzman

Regulatory Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranjith Ramasamy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Desai Sethi Urology Institute - University of Miami, Miller School of Medicine

Miami, Florida, United States

Countries

United States

Other Identifiers

20231090

Identifier Type: -

Identifier Source: org_study_id