Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

Not Applicable

Withdrawn

• Conditions: Vasculogenic Erectile Dysfunction
• Interventions: Device: Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

• Registration Number: NCT03843086
• Lead Sponsor: University of Virginia

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Study Start: 2019-06
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
720 Low Intensity shockwave therapy	Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction	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)
600 Low Intensity shockwaves therapy	Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction	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.

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF-EF) Questionnaire	7 months	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

Secondary Outcome Measures

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