Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

NCT04136288 | Completed Results FDA Device

• 1 other identifier: 18-001246
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (10)

• Change in Right Resistive Index

  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.

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

• Change in Right Peak Systolic Velocity

  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.

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

• Change in Right Diastolic Velocity

  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

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

• Erection Hardness Score (EHS)

  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.

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

• International Index of Erectile Function (IIEF - EF) Questionnaire

  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

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

• Sexual Encounter Profile (SEP) Questionnaire

  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.

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

• Global Assessment Questionnaire

  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.

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

• Change in Left Peak Systolic Velocity

  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.

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

• Change in Left Diastolic Velocity

  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

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

• Left Resistive Index

  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.

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

Study Arms (1)

Males with erectile dysfunction (ED)

EXPERIMENTAL

Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device

Device: MoreNova

Interventions

MoreNova DEVICE

Shockwave therapy delivered to the genital area with low dose shocks

Males with erectile dysfunction (ED)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The Covid-19 Pandemic was a limitation during the trial. The pandemic interfered with recruitment and follow-up of study subjects.

Results Point of Contact

• Title: Chandler Chapman, DHSc, MPH, Senior Clinical Research Coordinator
• Organization: Mayo Clinic

Chapman.Chandler@mayo.edu

9049538681

Study Officials

• Gregory Broderick, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: December 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)