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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT03006536
• Date of registration: 26/12/2016
• Prospective Registration: Yes
• Primary sponsor: Zealand University Hospital
• Public title: Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
• Scientific title: Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
• Date of first enrolment: October 1, 2017
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03006536
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Intervention(s)

Device: Li-ESWT

Primary Outcome(s)

International Index of Erectile Function (IIEF) [Time Frame: 1 months]

Secondary ID(s)

SJ-590

Source(s) of Monetary Support

Please refer to primary and secondary sponsors