Low Intensity Linear Shockwave Therapy for Erectile Dysfunction

Vasculogenic Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03843086
• Other study ID #: 21221
• Status: Withdrawn
• Phase: N/A
• Start date: June 2019
• Est. completion date: March 2022

Study information

• Verified date: May 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Vasculogenic Erectile Dysfunction

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	DIREX SYSTEMS CORPORATION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	GAQ (Global Assessment Questions) at follow-ups	2 Yes or No questions assessing improvement with treatment	7 months
Secondary	EHS (Erection Hardness Score) at follow-ups	Scale rating hardness of erection from 0-4 with 4 being highest	7 months