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

NCT ID: NCT03670628

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-11-12

Brief Summary

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

Conditions

Erectile Dysfunction

Study Design

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

Study Groups

720 shockwave therapy Group

Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)

Group Type: ACTIVE_COMPARATOR

Shockwave therapy

Intervention Type: DEVICE

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)

Sham shockwave therapy

Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).

Group Type: SHAM_COMPARATOR

Sham shockwave therapy

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: DEVICE

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ranjith Ramasamy, MD

Director of Male Fertility/ Andrology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranjith Ramasamy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20181840

Identifier Type: OTHER

Identifier Source: secondary_id

20180651

Identifier Type: -

Identifier Source: org_study_id