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Low Intensity Shockwave Therapy for Erectile Dysfunction

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04434352
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ryan Smith, MD, University of Virginia

Brief Summary:

Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of North America and American Urological Association have put forth guideline statements recommending additional investigation of this treatment modality.2

The current clinical armamentarium only treats the symptoms of erectile dysfunction without improving upon the underlying pathophysiology. LiSWT has been used effectively in musculoskeletal disorders and cardiovascular applications. Animal studies have shown improvements in angiogenesis and stem cell recruitment in other systems (cardiac and musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction since 2010 and is widely used in Europe and throughout the world. It is gaining widespread acceptance in the United States with a relative paucity of data in regards to its effectiveness.

While the majority of studies and meta-analyses show improvements in standardized erectile dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In addition, many studies have failed to assess a population of men who have highly prevalent erectile dysfunction, those men undergoing prostate cancer treatment.

This is a prospective, randomized, single blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED patients in three distinct patient populations. LiSWT has shown the potential to improve baseline erectile function but requires further study, which is the aim of this investigation.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Following Radiation Therapy Erectile Dysfunction Due to General Medical Condition Erectile Dysfunction Due to Arterial Insufficiency Device: Storz Duolith Low-Intensity Shockwave Therapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients will be randomized to either the treatment group or sham group.
Primary Purpose: Treatment
Official Title: Low Intensity Shockwave Therapy for Erectile Dysfunction
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Baseline Erectile Dysfunction
The first arm of the study will be those men with erectile dysfunction as defined by IIEF score. These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM score and EHS score. Each questionnaire is described in the trial description with a higher score indicating improved function.
Device: Storz Duolith Low-Intensity Shockwave Therapy

A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete.

B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete.

Other Name: Sham

Active Comparator: Erectile Dysfunction-Penile Rehabilitation
The second population of patients will be those who are planning to undergo treatment for prostate cancer. In a similar manner, men will be randomized to either the Sham or active treatment groups. Men will be treated prior to undergoing definitive treatment for prostate cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to prostate cancer treatment.
Device: Storz Duolith Low-Intensity Shockwave Therapy

A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete.

B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete.

Other Name: Sham

Active Comparator: Erectile Dysfunction Post-Prostate Cancer Treatment
The third population of patients will be those who have undergone treatment for prostate cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone prostatectomy or radiation therapy. Again, there will be a sham and treatment group.
Device: Storz Duolith Low-Intensity Shockwave Therapy

A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete.

B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete.

Other Name: Sham




Primary Outcome Measures :
  1. Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment [ Time Frame: 1 month ]

    The primary outcome will be change in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) score from baseline (pre-treatment) to 1 month after the end of treatment. The IIEF/SHIM score is a validated instrument to assess erectile function.

    Over the past 6 months:

    1. How do you rate your confidence that you could keep an erection?
    2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration (entering your partner)?
    3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?
    4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
    5. When you attempted sexual intercourse, how often was it satisfactory for you? Each item is scored 1-5, with a higher number indicating better rigidity.


Secondary Outcome Measures :
  1. Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment [ Time Frame: 3 and 6 months ]

    Changes in SHIM score (Sexual Health Inventory in Men) score at 3 and 6 months post-treatment.

    • The IIEF classifies men into groups of no erectile dysfunction, mild, mild to moderate, moderate and severe erectile dysfunction. Changes in the classifications will be compared between arms at 1, 3, and 6 months post-treatment.


  2. Adverse Event Rates [ Time Frame: 1, 3 and 6 months ]
    Adverse Events including bruising and pain.

  3. Change in Erection Hardness Score at 1, 3, and 6 months [ Time Frame: 1, 3, and 6 months ]

    Change in Erection Hardness Score

    The Erection Hardness score is another tool to evaluate erectile function and firmness. It is scored as follows:

    0-Penis does not enlarge

    1. Penis is larger, but not hard
    2. Penis is hard, but not hard enough for penetration
    3. Penis is hard enough for penetration, but not completely hard
    4. Penis is completely hard and fully rigid

    A higher score indicates a higher degree of erectile rigidity.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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 2 weeks before baseline IIEF.
  • Baseline IIEF-EF score ≥ 8 and ≤21. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF.
  • Testosterone level > 300 ng/dL. This includes patients on therapeutic testosterone therapy.
  • If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment.
  • Men may be on active surveillance for prostate cancer
  • Men who have undergone radical prostatectomy ≥ 12 months ago
  • Men who have undergone radiation therapy, either brachytherapy or external bean therapy ≥ 12 months ago

Exclusion Criteria:

  • History of extensive pelvic surgery ever.
  • Past radiation therapy of the pelvic region within 12 months prior to enrollment.
  • Recovering from any non-prostate related cancer within 12 months prior to enrollment.
  • Neurological disease which affects erectile function at the discretion of the investigator.
  • Anatomical malformation of the penis, including Peyronie's disease.
  • Testosterone level <300 within 3 month prior to enrollment.
  • HgbA1C level > 7.5% within 3 month prior to enrollment.
  • History of spinal cord injury.
  • Recovering from any non-prostate cancer malignancy within 12 months prior to 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): NCT04434352


Contacts
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Contact: Ryan P Smith, MD 434-243-7174 rps2k@virginia.edy
Contact: Lofton Neal 434-982-3704 lpn8p@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ryan P Smith, MD    434-243-7174    rps2k@virginia.edu   
Contact: Lofton Neal    434-982-3704    lpn8p@virginia.edu   
Sponsors and Collaborators
University of Virginia
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Responsible Party: Ryan Smith, MD, Associate Professor of Urology, University of Virginia
ClinicalTrials.gov Identifier: NCT04434352    
Other Study ID Numbers: IRB-HSR# 190082
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
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
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders