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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.

Official Title
-----------------
Randomized Control Trial of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction. 12- Month Follow-Up of a Double-Blinded, Sham-Controlled Study.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: Shockwave therapy
* Other: Sham shockwave therapy


Participation Criteria
=================
Eligibility 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 (inclusive). The patient has erectile dysfunction (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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 720 shockwave therapy Group<br>Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base) | Device: Shockwave therapy<br>* Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)<br>|
| Sham Comparator: Sham shockwave therapy<br>Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base). | Other: Sham shockwave therapy<br>* Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores. | The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function. | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire | The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions. | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | 
| Erection Hardness Score (EHS) | EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |