Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.

University of Miami1 site in 1 country23 target enrollmentMay 1, 2019

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: University of Miami
Enrollment: 23
Locations: 1
Primary Endpoint: International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
Status: Terminated
Last Updated: 2 years ago

The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.

Registry

clinicaltrials.gov

Start Date

May 1, 2019

End Date

November 12, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

Responsible Party

Principal Investigator

Ranjith Ramasamy, MD

Director of Male Fertility/ Andrology department

University of Miami

•The patient must be able willing and able to provide informed consent.
•The patient is a male between 30 and 70 years of age (inclusive).
•The patient has erectile dysfunction (ED) based of IIEF scores.
•The patient has been in a stable relationship for over 3 months prior to enrollment.
•A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
•The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
•IIEF-EF score between 16 and
•Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment

•The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.
•The patient is under judicial protection (prison or custody).
•The patient is an adult under guardianship.
•The patient refuses to sign the consent.
•History of radical prostatectomy or extensive pelvic surgery.
•Evidence of venous leak.
•Past radiation therapy of the pelvic region within 12 months prior to enrollment.
•Recovering from any cancer within 12 months prior to enrollment.
•Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
•Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.

International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.

Time Frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.

Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire(Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12)
Erection Hardness Score (EHS)(Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12)