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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670628
Recruitment Status : Suspended (Due to covid-19 pandemic)
First Posted : September 13, 2018
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Shockwave therapy Other: Sham shockwave therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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)
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)

Sham Comparator: 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).
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)




Primary Outcome Measures :
  1. Change in International Index of Erectile Function ( IIEF-EF) Scores [ Time Frame: Baseline, Up to 13 months ]
    The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.


Secondary Outcome Measures :
  1. Number of participants responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire [ Time Frame: Up to 13 months ]
    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.

  2. Number of participants responding 'Yes' to the Global Assessment Question (GAQ) [ Time Frame: Up to 13 months ]
    The GAQ consists of two questions: 1) Over the past 4 weeks, has the treatment you have been taking improved your erectile function? and 2) If yes, has the treatment improved your ability to engage in sexual activity over the past 4 weeks? Reported will be the number of participants responding yes to the 2 questions.

  3. Change in Erection Hardness Score (EHS) [ Time Frame: Baseline, Up to 13 months ]
    EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670628


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
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Responsible Party: Ranjith Ramasamy, MD, Director of Male Fertility/ Andrology department, University of Miami
ClinicalTrials.gov Identifier: NCT03670628    
Other Study ID Numbers: 20180651
20181840 ( Other Identifier: western IRB )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders