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

NCT06152146 | Withdrawn FDA Device

• 1 other identifier: 20231090
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in number of participants reporting on Penetrative Intercourse

  Number of participants reporting the ability to have penetrative intercourse with or without PDE5i but without the use of intracavernosal injections was chosen as the primary clinical efficacy assessment tool in this study.

  Baseline to 6 months and Baseline to 12 months.

Secondary Outcomes (5)

• Change in Penile blood flow (Penile Duplex Ultrasound) measured in centimeters per second (cm/sec)

  Baseline to 12 months.

• Change in IIEF-EF Scores

  Baseline to 6 months and Baseline to 12 months.

• Change in SEP- Sexual Encounter Profile: Questions 2 and 3

  Baseline to 6 months and Baseline to 12 months.

• Change in GAQ- Global Assessment Questions

  Baseline to 6 months and Baseline to 12 months.

• Change in EHS- Erection Hardness Score

  Baseline to 6 months and Baseline to 12 months.

Study Arms (2)

SWT group

ACTIVE COMPARATOR

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.

Device: Shockwave Therapy

SHAM group

PLACEBO COMPARATOR

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.

Other: SHAM shockwave therapy

Interventions

Shockwave Therapy 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)

SWT group

SHAM shockwave therapy 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)

SHAM group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide informed consent.
• Be male
• Be ≥ 40 and ≤ 75 years of age (inclusive).
• Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
• Be at least six weeks post radical prostatectomy.
• Be in a stable sexual relationship for over 3 months prior to enrollment.
• Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
• Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
• Have undetectable PSA value at the time of enrollment

You may not qualify if:

• 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.
• Be under judicial protection (prison or custody).
• Be an adult under guardianship.
• Refuse to sign the informed consent.
• Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
• Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
• Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
• Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
• 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).
• Have an anatomical malformation of the penis, including Peyronie's disease.
• Have testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
• Be using blood thinners with international normalized ratio (INR) to be \> 3.
• Have received shockwave therapy for at least 6 months before enrollment.
• Have detectable PSA value after the radical prostatectomy.
• Require radiation therapy after radical prostatectomy.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

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

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regulatory Specialist

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 30, 2023
• Study Start: July 8, 2024
• Primary Completion: December 15, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)