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Completed

NCT Number: NCT04136288

Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.

The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy).

LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have given his informed and signed written consent
  • The patient is a male
  • Between 40 to and including 55 years of age
  • The patient has ED for longer than 1 year but less than 5 years.
  • The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
  • IIEF-EF Domain score of 17-20
  • Evidence Based Criteria: Doppler Clinical Exam

Exclusion criteria

  • The patient is participating in another study that may interfere with the results or conclusions of this study
  • History of radical prostatectomy or extensive pelvic surgery
  • Past radiation therapy of the pelvic region within 12 months prior to enrollment
  • Recovering from cancer within 12 months prior to enrollment
  • Neurological disease which effects erectile function
  • Psychiatric disease which effects erectile function
  • The patient is taking blood thinners
  • History of Diabetes Mellitus
  • History of Coronary Artery Disease
  • Evidence Based Criteria: Doppler Clinical Exam
  • Severe erectile dysfunction with IIEF-EF domain score < 16

Treatment and study plan

MoreNova

Device

Shockwave therapy delivered to the genital area with low dose shocks

Primary outcomes

  1. Change in Right Resistive Index

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Resistive Index (RI) is a measure of resistance to blood flow within the right penile arteries.

    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

    Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis.

  2. Change in Right Peak Systolic Velocity

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Peak systolic velocity (PSV): The maximum velocity of blood flow during erection.

    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

    A PSV higher than 35 cm/sec is regarded as normal, a 25-35 cm/sec may indicate moderate-to-mean arterial damage, and a PSV lower than 25 may indicate the presence of severe arteriopathy.

  3. Change in Right Diastolic Velocity

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Diastolic Velocity (DV) represents the velocity of right-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse).

    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

  4. Erection Hardness Score (EHS)

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Measured using a self-reported Erection Hardness Score (EHS) scale options from 0 (minimum) to 4 (maximum).

    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, or 4-Penis is completely hard and fully rigid.

    A lower score indicates a worse outcome. A higher score indicates a better outcome.

  5. International Index of Erectile Function (IIEF - EF) Questionnaire

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Measured using a self-reported International Index of Erectile Function questionnaire (IIEF - EF) consisting of 6 questions regarding the participants erectile function for the past 4 weeks. The questionnaire utilizes a scale of 0 (minimum) to 5 (maximum).

    A lower score indicates a worse outcome. A higher score indicates a better outcome.

    Questions 1-2 scale: 0=No sexual activity, 1= Almost never/never, 2= A few times (much less than half the time),3= Sometimes (about half the time), 4= Most times (much more than half the time),5= Almost always/always

    Questions 3-4 scale: 0=Did not attempt, 1=Almost never/never, 2= A few times (much less than half the time), 3= Sometimes (about half the time), 4= Most times (much more than half the time), 5= Almost always/always

    Question 5 scale:0=Did not attempt intercourse,1= Extremely difficult, 2=Very Difficult, 3=Difficult, 4= Slightly Difficult, 5= No Difficult

    Question 6 scale: 1= Very low, 2=Low, 3=Moderate, 4=High, 5= Very high

  6. Sexual Encounter Profile (SEP) Questionnaire

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Measured using a self-reported Sexual Encounter Profile (SEP) Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options.

    No, indicates a worse outcome. Yes, indicates a better outcome.

  7. Global Assessment Questionnaire

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Measured using a self-reported Global Assessment Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options.

    No, indicates a worse outcome. Yes, indicates a better outcome.

  8. Change in Left Peak Systolic Velocity

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

    A Peak Systolic Velocity of 25-35 cm/s or higher is considered normal. This reflects the maximum velocity of blood flow during erection.

  9. Change in Left Diastolic Velocity

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Diastolic Velocity (DV) represents the velocity of left-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse).

    Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

  10. Left Resistive Index

    Time frame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour

    Resistive Index (RI) is a measure of resistance to blood flow within the left penile arteries.

    Measured Left Resistive Index using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second

    Elevated values are associated with poorer prognosis. Lower values are associated with a better prognosis.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2019
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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