Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

NCT ID: NCT03843086

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2022-03-31

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.

Conditions

Vasculogenic Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

Intervention Type: DEVICE

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)

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.

Group Type: ACTIVE_COMPARATOR

Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

MoreNova

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

DIREX SYSTEMS CORPORATION

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Ryan Smith, MD

Assistant Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan P Smith, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Other Identifiers

21221

Identifier Type: -

Identifier Source: org_study_id