Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up

Lead Sponsor: University of Miami

Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia1. Even though it is not a part of normal aging, it is seen in 52% men in the age group 40 to 70 years, with a higher rate in the men more than 70 years2

Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia1. Even though it is not a part of normal aging, it is seen in 52% men in the age group 40 to 70 years, with a higher rate in the men more than 70 years.

MoreNova is a Linear Shockwave (LISW) device, which incorporates a shockwave transducer operable to deliver shockwaves to a treatment region confined to a narrow rectangle. Shockwaves generation follows the electromagnetic principle.

Linear Shockwaves (LISW), as a treatment for ED has been in evaluation in contemporary medicine (see section 1.4). It has been in use for the last five years.

The present study will utilize a device called "MoreNova", in which shockwaves are focused onto line segments for improved organ coverage. Shockwaves produced by "MoreNova" 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 of LISW in the treatment of ED.

• Erectile Dysfunction

Intervention Type: Device

Intervention Name: Shockwave therapy

Description: This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 2:1 ratio of active to sham treatment groups. Patients randomized to the treatment group will be instructed to stop any use of PDE5i for 4 weeks prior to first treatment session and refrain from using any other ED therapy option during the study. They will be instructed to undergo a PDE5i washout period of 4 weeks prior to treatment. After the washout period and before the first treatment session, patients will answer the IIEF-EF, SEP and EHS questionnaires for baseline evaluation. Penile Doppler ultrasound will be performed by the time of enrollment, at 1,3, 6, 9 and 12 months and after treatment.

Criteria:

Inclusion Criteria:

- • The patient must be able willing and able to provide informed consent.

- The patient is a male between >30 and <70 years of age.

- The patient has ED based of IIEF scores.

- The patient has been in a stable relationship for over 3 months prior to enrollment.

- A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)

- The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.

- IIEF-EF score between 16 and 25.

- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment

Exclusion Criteria:

- The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.

- The patient is under judicial protection (prison or custody).

- The patient is an adult under guardianship.

- The patient refuses to sign the consent.

- History of radical prostatectomy or extensive pelvic surgery.

- Evidence of venous leak.

- Past radiation therapy of the pelvic region within 12 months prior to enrollment.

- Recovering from any cancer within 12 months prior to enrollment.

- Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.

- Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.

- Anatomical malformation of the penis, including Peyronie's disease.

- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.

- A1C level > 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.

- The patient is taking blood thinners and has an international normalized ratio >3.

- Received shockwave treatment at least 6 months before enrollment.

Gender: Male

Gender Based: Yes

Minimum Age: 30 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Last Name: Manuel Molina, MD

Phone: 3052434873

Email: [email protected]

United States

May 2020

Type: Principal Investigator

Investigator Affiliation: University of Miami

Investigator Full Name: Ranjith Ramasamy, MD

Investigator Title: Director of Male Fertility/ Andrology department

• Erectile Dysfunction

Label: 720 shockwave therapy

Type: Active Comparator

Description: 5 Daily sessions of shockwave therapy within a week.( Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shock of treatment energy will be applied in every session to each region ( left and right corpora cavernosa and crura)

Label: None shockwave therapy

Type: Sham Comparator

Description: 5 Daily sessions of shockwave therapy within a week.( Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shock of treatment energy will be applied in every session to each region ( left and right corpora cavernosa and crura. The device probe, will be covered with a cap that will stopped the transmission of shockwaves.

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)