Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules

MoreNovaED is a Linear Shockwaves (LISW) device in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by MoreNovaED 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 ED.

Study Overview

• Status: Withdrawn
• Conditions: Vasculogenic Erectile Dysfunction
• Intervention / Treatment: Device: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

Detailed Description

Morenova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a treated region confined to a narrow rectangle. Shockwaves generation follows the electromagnetic principle. Low intensity shockwaves do not inflict pain and anesthesia or sedation is not required.

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

Rationale:Linear Shockwaves has been known to bolster angiogenesis by increasing the levels of vascular endothelial growth factor.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. The patient has been correctly informed about the study
2. The patient must have given his informed and signed consent
3. The patient is a man between 40 and 80 years of age
4. The patient has ED of Vasculogenic origin
5. The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
6. The patient has been in a stable heterosexual relationship for over 3 months prior to enrollment
7. A minimum of 2 sexual attempts per month for at least one month prior to enrollment
8. The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years
9. IIEF-EF score between 17 and 25
10. Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
11. A1C level ≤ 7% within 1 month prior to enrollment
12. Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1).

Exclusion Criteria:

1. The patient is participating in another study that may interfere with the results or conclusions of this study
2. Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
3. The patient is in an exclusion period determined by a previous study
4. The patient is under judicial protection
5. The patient is an adult under guardianship
6. The patient refuses to sign the consent
7. It is impossible to correctly inform the patient
8. History of radical prostatectomy or extensive pelvic surgery
9. Venous leak
10. Past radiation therapy of the pelvic region within 12 months prior to enrollment
11. Recovering from cancer within 12 months prior to enrollment
12. Neurological disease which effects erectile function
13. Psychiatric disease which effects erectile function
14. Anatomical malformation of the penis, including Peyronie's disease
15. Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
16. A1C level > 7% within 1 month prior to enrollment
17. The patient is taking blood thinners and has an international normalized ratio >3.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 720 Low Intensity shockwave therapy; Five daily sessions within a week, Monday thru Friday, in which 720 shocks of treatment energy applied 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 using low intensity shockwave therapy. 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 Names: MoreNova
Active Comparator: 600 Low Intensity shockwaves therapy; Three weekly sessions for 2 consecutive weeks, Monday-Wednesday-Friday, in which 600 shocks of treatment energy applied 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 using low intensity shockwave therapy. 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 Names: MoreNova

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Index of Erectile Function (IIEF-EF) Questionnaire	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	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SEP (Sexual Encounter Profile) 2 & 3 at follow-ups	Sexual activity improvement leading to optimal penetration at follow-ups. 2 Yes or No questions	7 months
GAQ (Global Assessment Questions) at follow-ups	2 Yes or No questions assessing improvement with treatment	7 months
EHS (Erection Hardness Score) at follow-ups	Scale rating hardness of erection from 0-4 with 4 being highest	7 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: DIREX SYSTEMS CORPORATION
• Investigators: Principal Investigator: Ryan P Smith, M.D., University of Virginia

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: 21221 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No