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Trial record 14 of 62 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

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

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ClinicalTrials.gov Identifier: NCT03006536
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Nessn Azawi, 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).

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Li-ESWT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: 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

Sham Comparator: 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
Device: 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 :
  1. International Index of Erectile Function (IIEF) [ Time Frame: 1 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006536


Locations
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Denmark
Zealand University Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Nessn H. Azawi, M.D.    004526393034    nesa@regionsjaelland.dk   
Principal Investigator: Nessn Azawi, M.D.         
Sponsors and Collaborators
Zealand University Hospital

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Responsible Party: Nessn Azawi, Chief Urologist, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03006536     History of Changes
Other Study ID Numbers: SJ-590
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders