Clinical trial NCT04136288: Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
Official title: Immediate and Short Term Efficacy of Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction Due to Mild - Moderate Cavernous Arterial Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via MoreNova in the treatment of erectile dysfunction (ED).

Detailed description: ED is broadly defined as the inability to achieve or maintain an erection sufficient for sexual intercourse or activity. Current treatment for ED consists of oral medications, intracavernosal injections and surgically placed penile prosthetics. In the literature this has been described as a Stepwise Approach, offering therapy beginning with the least invasive treatment option.

The goal of LISWT is to restore natural erections and / or improve responses to oral medications (first line therapy).

LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines on ED were recently updated to include LISWT for men with mild to moderate ED. The energy/pulse used in this application is approximately 10% of the energy used for disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy for diabetic ulcers has recently been approved by the FDA.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his informed and signed written consent
* The patient is a male
* Between 40 to and including 55 years of age
* The patient has ED for longer than 1 year but less than 5 years.
* The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
* IIEF-EF Domain score of 17-20
* Evidence Based Criteria: Doppler Clinical Exam

Exclusion Criteria:

* The patient is participating in another study that may interfere with the results or conclusions of this study
* History of radical prostatectomy or extensive pelvic surgery
* Past radiation therapy of the pelvic region within 12 months prior to enrollment
* Recovering from cancer within 12 months prior to enrollment
* Neurological disease which effects erectile function
* Psychiatric disease which effects erectile function
* The patient is taking blood thinners
* History of Diabetes Mellitus
* History of Coronary Artery Disease
* Evidence Based Criteria: Doppler Clinical Exam
* Severe erectile dysfunction with IIEF-EF domain score \< 16

Primary outcomes:
measure: Change in Right Resistive Index
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Change in Right Peak Systolic Velocity
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Change in Right Diastolic Velocity
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Erection Hardness Score (EHS)
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: International Index of Erectile Function (IIEF - EF) Questionnaire
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Sexual Encounter Profile (SEP) Questionnaire
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Global Assessment Questionnaire
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Change in Left Peak Systolic Velocity
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Change in Left Diastolic Velocity
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
measure: Left Resistive Index
timeFrame: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Gregory Broderick, MD
role: PRINCIPAL_INVESTIGATOR
References: