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Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03067987
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
DIREX SYSTEMS CORPORATION
Information provided by (Responsible Party):
Ranjith Ramasamy, University of Miami

Brief Summary:

Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves are aimed at the left and right corpora cavernosa and the crura. The study is aimed at determining the safety and effectiveness of this new type LISW in the relief of erectile dysfunction.

HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate erectile dysfunction and will show significant change.

Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment groups for alleviating erectile dysfunction measured using International Index of Erectile Function score (IIEF-EF).

Primary Efficacy Objective: To evaluate change of International Index of Erectile Function score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.

Secondary Objectives:To study sexual activity improvement leading to optimal penetration at follow-ups according to:

  • SEP- Sexual Encounter Profile Questionnaire.
  • GAQ- Global Assessment Questionnaire.
  • EHS- Erection Hardness Score.

Condition or disease Intervention/treatment Phase
Vasculogenic Erectile Dysfunction Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : June 22, 2018
Estimated Study Completion Date : September 22, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 720 shockwave therapy
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. The patients are randomized in a 1:1 ratio into two active treatment groups.

Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).

Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)

Other Name: RENOVA-ED
Active Comparator: 600 shockwave therapy

Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)

Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor, in terms of type and dose of drug, for the remainder of study duration.

Device: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. The patients are randomized in a 1:1 ratio into two active treatment groups.

Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).

Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)

Other Name: RENOVA-ED



Primary Outcome Measures :
  1. International Index of Erectile Function (IIEF-EF) Questionnaire [ Time Frame: 7 months ]
    The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials


Secondary Outcome Measures :
  1. Sexual Encounter profile (SEP) [ Time Frame: 7 months ]

    A measure of the efficacy of erectile dysfunction therapy. Format: 5 items addressing the sexual events the respondent experienced when attempting intercourse.

    Administration and Burden: Interviewer-administered; Self-administered. Approximately 5 minutes.


  2. Global Assessment Question (GAQ) [ Time Frame: 7 months ]

    A measure of perceived improvements in erectile function and sexual ability. Format: 2 items asking about improvements in erectile function and ability to engage in sexual activity.

    Scoring: Categorical data can be obtained from this measure. Administration and Burden: Interviewer-administered; Self-administered. Less than 5 minutes.


  3. Erection Hardness Score (EHS) [ Time Frame: 7 months ]
    EHS rates the hardness of erection on a scale of one to four, with four being the maximal score



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be willing and able to provide informed consent.
  • The patient is a male between >30 and <80 years of age.
  • PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 4 weeks before IIEF.
  • Stable sexual relationship for over 3 months prior to enrollment.
  • A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
  • Erectile dysfunction lasting for over 6 months and not more than 5 years.
  • Baseline IIEF-EF score between 11 and 25. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF-EF.
  • Testosterone level 300-1000 ng/dL.
  • If diabetic, HgbA1C level ≤ 7.5% 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 ever.
  • 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 Parkinsons disease which affects erectile function at the discretion of the investigator.
  • Psychiatric diagnosis or medications such as antidepressants which 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.
  • HgbA1C level > 7.5% within 1 month prior to enrollment.
  • Androgen deprivation treatment in the last year.
  • History of spinal cord injury.
  • The patient is taking blood thinners (eg Coumadin, Plavix)

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): NCT03067987


Contacts
Contact: Manuel Molina, MD 305-243-4873 ext 1176 mxm2220@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Manuel Molina, MD    305-243-4873 ext 1176    mxm22202@med.miami.edu   
Principal Investigator: Ranjith Ramasamy, MD         
Sponsors and Collaborators
University of Miami
DIREX SYSTEMS CORPORATION
Investigators
Principal Investigator: Ranjith Ramasamy, MD University of Miami

Publications:

Responsible Party: Ranjith Ramasamy, Urologist/ Director of Male Reproductive Medicine/ Assistant professor Urology Department University of Miami, University of Miami
ClinicalTrials.gov Identifier: NCT03067987     History of Changes
Other Study ID Numbers: 20160964
20160335 ( Other Identifier: Institutional Review Board )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders