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

Primary Purpose

Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Li-ESWT
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Li-ESWT

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

International Index of Erectile Function (IIEF)

Secondary Outcome Measures

Full Information

First Posted
December 26, 2016
Last Updated
September 16, 2021
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03006536
Brief Title
Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
Official Title
Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 13, 2022 (Anticipated)
Study Completion Date
March 13, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Li-ESWT
Arm Type
Experimental
Arm Description
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
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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
Intervention Name(s)
Li-ESWT
Intervention Description
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 Measure Information:
Title
International Index of Erectile Function (IIEF)
Time Frame
1 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nessn H. Azawi, M.D.
Phone
004526393034
Email
nesa@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Nessn Azawi, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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