Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03670628
• Other study ID #: 20180651
• Secondary ID: 20181840
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 12, 2021

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 25.
• Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level = 7% within 1 month prior to enrollment

Exclusion Criteria:

• 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.
• Anatomical malformation of the penis, including Peyronie's disease.
• Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
• A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
• The patient is taking blood thinners and has an international normalized ratio >3.
• Received shockwave treatment at least 6 months before enrollment.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Shockwave therapy
Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

Other:
• Sham shockwave therapy
Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.	The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.	Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Secondary	Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire	The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.	Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Secondary	Erection Hardness Score (EHS)	EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness	Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12