NCT02063061

Brief Summary

The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

January 9, 2014

Last Update Submit

December 23, 2016

Conditions

Erectile Dysfunction

Keywords

extracorporeal shock wave therapy ESWTerectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function (IIEF) outcome increases by 5 points

    1 year

Secondary Outcomes (1)

  • Erectile Hardness Scale (EHS) outcome is equal or higher than 3.

    1 year

Other Outcomes (2)

  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome

    18 weeks

  • Number of Participants with Adverse Events

    18 weeks

Study Arms (2)

Sham treatment

SHAM COMPARATOR

Subject will answer standardized questionnaires. Sham treatment arm will receive initially 5 sham series and after they answer standardized questionnaires they will receive 5 series of active treatment. Afterwards patients will answer standardized questionnaires again.

Device: Sham treatmentDevice: ESWT treatment

ESWT treatment

ACTIVE COMPARATOR

Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.

Device: ESWT treatment

Interventions

Sham treatmentDEVICE

Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.

Also known as: Sham
Sham treatment
ESWT treatmentDEVICE

ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.

Also known as: ESWT
ESWT treatmentSham treatment

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Erectile dysfunction for at least 6 months
  • In relationships
  • Patient accept not to use any other therapy against erectile dysfunction

You may not qualify if:

  • Prostatectomy
  • Radiotherapy in pelvis
  • Hormonal therapy against prostate cancer
  • Anatomical penis disorder
  • Penile prosthesis
  • Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
  • Psychiatric disorder
  • Hypogonadism
  • IIEF score higher than 25
  • Pregnant partner og delivered within last 12 months
  • Critical health disease
  • Neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Southern Denmark

Sønderborg, Southern Denmark, 6400, Denmark

Location

Related Publications (3)

  • Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013 Apr;5(2):95-9. doi: 10.1177/1756287212470696.

    PMID: 23554844RESULT

  • Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.

    PMID: 22008059RESULT

  • Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.

    PMID: 20451317RESULT

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Palle Oshter, professor

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

December 1, 2015

Last Updated

December 28, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)