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

Primary Purpose

Erectile Dysfunction

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Shockwave therapy

Sham shockwave therapy

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.
- The patient has 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.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

720 shockwave therapy Group

Sham shockwave therapy

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Erection Hardness Score (EHS)

EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness

Full Information

NCT ID

NCT03670628

First Posted

September 10, 2018

Last Updated

June 20, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT03670628

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

Due to COVID-19 Pandemic

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

November 12, 2021 (Actual)

Study Completion Date

November 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

720 shockwave therapy Group

Arm Type

Active Comparator

Arm Description

Arm Title

Sham shockwave therapy

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Shockwave therapy

Intervention Description

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

Other

Intervention Name(s)

Sham shockwave therapy

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Secondary Outcome Measure Information:

Title

Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire

Description

Time Frame

Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

Title

Erection Hardness Score (EHS)

Description

EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness

Time Frame

Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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