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

NCT ID: NCT03006536

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2022-03-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Li-ESWT

Intervention Type: 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

Sham

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

Group Type: SHAM_COMPARATOR

Li-ESWT

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nessn Azawi

Chief Urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zealand University Hospital

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

SJ-590

Identifier Type: -

Identifier Source: org_study_id