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Completed

NCT Number: NCT03006536

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

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).

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. International Index of Erectile Function (IIEF)

    Time frame: 1 months

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2016
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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