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Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

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ClinicalTrials.gov Identifier: NCT02068417
Recruitment Status : Terminated (It has been decided to improve the inclusion criteria for better study outcome)
First Posted : February 21, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Storz Medical AG

Brief Summary:
The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: shock waves Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
Study Start Date : October 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Shock wave treatment
Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)
Device: shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Other Names:
  • ESWT
  • extracorporeal shock wave therapy

Placebo Comparator: Placebo Shock wave treatment
Shock waves are prohibited to enter the body by placebo stand-off.
Device: shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Other Names:
  • ESWT
  • extracorporeal shock wave therapy




Primary Outcome Measures :
  1. Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire) [ Time Frame: up to 6 months post treatment ]

Secondary Outcome Measures :
  1. Quality of erection (Quality of Erection Questionnaire) [ Time Frame: At screening, 1, 3 and 6 months post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Erectile dysfunction for more than 6 months
  • Informed consent
  • Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
  • IIEF-15 score less than 20
  • No neurological disease
  • Stable partnership for more than 3 months
  • Age 18-75

Exclusion Criteria:

  • Total prostatectomy
  • Another reason for ED except for vascular disorder
  • Clinically significant hematological disease
  • Heart stroke, Arrythmia during the last 6 months
  • Cancer during the last 5 years
  • Intake of antiandrogen
  • ED treatment with the last 7 days
  • IIEF score higher than, equal to 20
  • Previous shockwave treatment

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): NCT02068417


Locations
Germany
Bethanien Krankenhaus Chemnitz gemeinnützige GmbH
Chemnitz, Germany
Sponsors and Collaborators
Storz Medical AG

Responsible Party: Storz Medical AG
ClinicalTrials.gov Identifier: NCT02068417     History of Changes
Other Study ID Numbers: STU10/002
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Storz Medical AG:
IIEF score
ED

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