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Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

Primary Purpose

Vasculogenic Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Shockwave system
Sham treatment
Sponsored by
Initia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasculogenic Erectile Dysfunction focused on measuring Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Good general health
  • Vasculogenic ED for at least 6 months
  • International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
  • Positive response to PDE5-I (able to penetrate on demand, Responders)
  • Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
  • Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • Psychogenic ED
  • Neurological pathology
  • Hormonal pathology
  • Past radical prostatectomy
  • Recovering from cancer during last 5 years
  • Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Radiotherapy in pelvic region

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Shockwaves

Control Group

Arm Description

4 weekly sessions of low-intensity shockwave therapy

Outcomes

Primary Outcome Measures

Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment

Secondary Outcome Measures

Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment
Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment

Full Information

First Posted
March 18, 2013
Last Updated
May 11, 2015
Sponsor
Initia
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1. Study Identification

Unique Protocol Identification Number
NCT01814852
Brief Title
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction
Official Title
A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Initia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Detailed Description
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculogenic Erectile Dysfunction
Keywords
Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Shockwaves
Arm Type
Experimental
Arm Description
4 weekly sessions of low-intensity shockwave therapy
Arm Title
Control Group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Shockwave system
Other Intervention Name(s)
Renova
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.
Primary Outcome Measure Information:
Title
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment
Time Frame
1, 3 and 6 months post treatment
Secondary Outcome Measure Information:
Title
Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment
Time Frame
1, 3 and 6 months post treatment
Title
Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment
Time Frame
1, 3 and 6 months post treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Good general health Vasculogenic ED for at least 6 months International Index of Erectile Function 6 (IIEF-EF) between 11 to 25 Positive response to PDE5-I (able to penetrate on demand, Responders) Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders) Stable heterosexual relationship for more than 3 months Exclusion Criteria: Psychogenic ED Neurological pathology Hormonal pathology Past radical prostatectomy Recovering from cancer during last 5 years Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities Clinically significant chronic hematological disease Anti-androgens, oral or injectable androgens Radiotherapy in pelvic region
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Gur, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20451317
Citation
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.
Results Reference
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PubMed Identifier
22999553
Citation
Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
Results Reference
background
PubMed Identifier
12152111
Citation
Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
Results Reference
background
PubMed Identifier
21855209
Citation
Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
Results Reference
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Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

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