Randomized Controlled Trial of Low Intensity Shockwaves Therapy for the Treatment of Post-Radical Prostatectomy Erectile Dysfunction. SHARP-ED TRIAL

University of Miami1 site in 1 countryJuly 8, 2024

ConditionsErectile Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: University of Miami
Locations: 1
Primary Endpoint: Change in number of participants reporting on Penetrative Intercourse
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 8, 2024

End Date

June 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Russell Saltzman

Regulatory Specialist

University of Miami

Eligibility Criteria

Inclusion Criteria

•Be willing and able to provide informed consent.
•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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Change in number of participants reporting on Penetrative Intercourse

Time Frame: Baseline to 6 months and Baseline to 12 months.

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.

Secondary Outcomes

Change in GAQ- Global Assessment Questions(Baseline to 6 months and Baseline to 12 months.)
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 EHS- Erection Hardness Score(Baseline to 6 months and Baseline to 12 months.)