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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: Li-ESWT

• Registration Number: NCT03006536
• Lead Sponsor: Zealand University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Study Start: 2017-10-01
• Primary Completion: 2022-03-13
• Study Completion: 2022-03-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-27
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	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
Li-ESWT	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

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF)	1 months

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Denmark