Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction

Not Applicable

Completed

Conditions: Erectile Dysfunction

Interventions: Device: MoreNova

Registration Number: NCT04136288

Lead Sponsor: Mayo Clinic

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Right Resistive Index	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.
Change in Right Peak Systolic Velocity	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.
Change in Right Diastolic Velocity	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
Erection Hardness Score (EHS)	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.
International Index of Erectile Function (IIEF - EF) Questionnaire	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
Sexual Encounter Profile (SEP) Questionnaire	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.
Global Assessment Questionnaire	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.
Change in Left Peak Systolic Velocity	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.
Change in Left Diastolic Velocity	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
Left Resistive Index	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.