Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial

Erectile Dysfunction Clinical Trial

Official title:

Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006536
• Other study ID #: SJ-590
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 13, 2022

Study information

• Verified date: January 2024
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 13, 2022
• Est. primary completion date: March 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years
• A history of erectile dysfunction for >6 months
• IIEF-ED score < 25
• In a stable heterosexual relationship for at least 6 months
• Willingness to attempt sexual intercourse at least twice per week during the study and follow-up

Exclusion Criteria:

• Psychogenic ED as assessed by a standardized interview (attachment 2)
• Known psychiatric illness
• Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord injury, and a history of stroke)
• Traumatic nerve injury
• Previous pelvic surgery or radiation
• Heart disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease
• Endocrine disease including hypogonadism (total testosterone <12 nmol/l)
• Insulin dependent or uncontrolled diabetes mellitus
• Dependence on erectogenic aids other than PDE5-Inhibitors
• Use of medications which have been shown to interfere with erections
• Use of anticoagulant medications other than low dose aspirin
• Active cancer
• A diagnoses of Peyronie's disease and/or prior occurrence of priapism
• Alcohol abuse (more than 21 containers of alcohol per week)

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Li-ESWT
Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Function (IIEF)		1 months