Clinical trial NCT03670628: Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 23
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.


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.

Primary outcomes:
measure: International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Secondary outcomes:
measure: Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
measure: Erection Hardness Score (EHS)
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ranjith Ramasamy, MD
role: PRINCIPAL_INVESTIGATOR
References: