search
Back to results

Linear Focused Shockwave Treatment for Erectile Dysfunction

Primary Purpose

Vasculogenic Erectile Dysfunction

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renova
Sponsored by
Initia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasculogenic Erectile Dysfunction

Eligibility Criteria

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

Inclusion Criteria:

  1. Good general health
  2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
  3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
  4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
  5. Stable sexual relationship for at least 3 months prior to treatment
  6. Minimum of two sexual attempts per month

Exclusion Criteria:

  1. Hormonal, neurological or psychological pathology
  2. Past radical prostatectomy or extensive pelvic surgery
  3. Recovering from cancer during last year
  4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
  5. Clinically significant chronic hematological disease
  6. Anti-androgens, oral or injectable androgens
  7. Past radiotherapy treatment of the pelvic region
  8. International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)

Sites / Locations

  • Eastchester Center for Cancer Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

long protocol

short protocol

Arm Description

Renova

Renova

Outcomes

Primary Outcome Measures

IIEF-EF- International Index of Erectile Function questionnaire score
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
IIEF-EF questionnaire score
IIEF-EF questionnaire score
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment

Secondary Outcome Measures

SEP- Sexual Encounter Profile: Questions 2 and 3
GAQ- Global Assessment Questions
EHS- Erection Hardness Score

Full Information

First Posted
May 22, 2014
Last Updated
August 8, 2022
Sponsor
Initia
search

1. Study Identification

Unique Protocol Identification Number
NCT02152683
Brief Title
Linear Focused Shockwave Treatment for Erectile Dysfunction
Official Title
Linear Focused Shockwave Treatment for Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
long protocol
Arm Type
Experimental
Arm Description
Renova
Arm Title
short protocol
Arm Type
Experimental
Arm Description
Renova
Intervention Type
Device
Intervention Name(s)
Renova
Intervention Description
Low- Intensity Shockwave
Primary Outcome Measure Information:
Title
IIEF-EF- International Index of Erectile Function questionnaire score
Description
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Time Frame
1 month post treatment
Title
IIEF-EF questionnaire score
Time Frame
3 months post treatment
Title
IIEF-EF questionnaire score
Description
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Time Frame
6 months post treatment
Secondary Outcome Measure Information:
Title
SEP- Sexual Encounter Profile: Questions 2 and 3
Time Frame
1, 3 and 6 months post treatment
Title
GAQ- Global Assessment Questions
Time Frame
1, 3 and 6 months post treatment
Title
EHS- Erection Hardness Score
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- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25 Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors Stable sexual relationship for at least 3 months prior to treatment Minimum of two sexual attempts per month Exclusion Criteria: Hormonal, neurological or psychological pathology Past radical prostatectomy or extensive pelvic surgery Recovering from cancer during last year Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities Clinically significant chronic hematological disease Anti-androgens, oral or injectable androgens Past radiotherapy treatment of the pelvic region International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)
Facility Information:
Facility Name
Eastchester Center for Cancer Care
City
New York
State/Province
New York
ZIP/Postal Code
10469
Country
United States

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
background
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
background

Learn more about this trial

Linear Focused Shockwave Treatment for Erectile Dysfunction

We'll reach out to this number within 24 hrs