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

NCT03006536 | Completed DMC

• 1 other identifier: SJ-590
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF)

  1 months

Study Arms (2)

Li-ESWT

EXPERIMENTAL

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

Device: Li-ESWT

Sham

SHAM COMPARATOR

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

Device: Li-ESWT

Interventions

Li-ESWT DEVICE

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

Li-ESWT; Sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Urologist

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: December 30, 2016
• Study Start: October 1, 2017
• Primary Completion: March 13, 2022
• Study Completion: March 13, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

DK (1)