Clinical trial NCT03843086: Low Intensity Linear Shockwave Therapy for Erectile Dysfunction
Official title: Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction - Comparison of Two Treatment Schedules
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vasculogenic Erectile Dysfunction
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: DIREX SYSTEMS CORPORATION
First posted: 2019-02-15
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: International Index of Erectile Function (IIEF-EF) Questionnaire
timeFrame: 7 months
Secondary outcomes:
measure: SEP (Sexual Encounter Profile) 2 & 3 at follow-ups
timeFrame: 7 months
measure: GAQ (Global Assessment Questions) at follow-ups
timeFrame: 7 months
measure: EHS (Erection Hardness Score) at follow-ups
timeFrame: 7 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Ryan P Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References: