- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02152683
Linear Focused Shockwave Treatment for Erectile Dysfunction
August 8, 2022 updated by: Initia
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10469
- Eastchester Center for Cancer Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: long protocol
Renova
|
Low- Intensity Shockwave
|
EXPERIMENTAL: short protocol
Renova
|
Low- Intensity Shockwave
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IIEF-EF- International Index of Erectile Function questionnaire score
Time Frame: 1 month post treatment
|
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
|
1 month post treatment
|
IIEF-EF questionnaire score
Time Frame: 3 months post treatment
|
3 months post treatment
|
|
IIEF-EF questionnaire score
Time Frame: 6 months post treatment
|
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
|
6 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SEP- Sexual Encounter Profile: Questions 2 and 3
Time Frame: 1, 3 and 6 months post treatment
|
1, 3 and 6 months post treatment
|
GAQ- Global Assessment Questions
Time Frame: 1, 3 and 6 months post treatment
|
1, 3 and 6 months post treatment
|
EHS- Erection Hardness Score
Time Frame: 1, 3 and 6 months post treatment
|
1, 3 and 6 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
May 22, 2014
First Submitted That Met QC Criteria
May 28, 2014
First Posted (ESTIMATE)
June 2, 2014
Study Record Updates
Last Update Posted (ACTUAL)
August 11, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LISW-NY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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