- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02005731
Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction (LISW)
June 10, 2014 updated by: Initia
A Prospective Multicenter Pilot Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction
This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
58
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
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Brno, Czech Republic
- Urologickaambulance
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Klaipėda, Lithuania
- Amber Clinic
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Amsterdam, Netherlands
- Men's Health Clinic, Amstelland Hospital
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Ramallah, Palestinian Territories, Occupied
- Urology and Andrology Center, Red Crescent Hospital (RCH)
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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
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Sexual Medicine clinic
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Shockwaves
Low intensity linear focused shockwave device ('Renova')
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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1, 3 and 6 months post treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
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1, 3 and 6 months post treatment
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Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
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1, 3 and 6 months post treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cobi Reisman, MD, PhD, Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands
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
- 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.
- 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.
- 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.
- 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.
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
November 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Estimate)
June 11, 2014
Last Update Submitted That Met QC Criteria
June 10, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSWT-004-EU
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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InitiaTerminatedVasculogenic Erectile DysfunctionUnited States
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University of VirginiaDIREX SYSTEMS CORPORATIONWithdrawnVasculogenic Erectile Dysfunction
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University of MiamiDIREX SYSTEMS CORPORATIONCompletedVasculogenic Erectile DysfunctionUnited States
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Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
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InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
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InitiaCompletedVasculogenic Erectile DysfunctionIsrael
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Central Clinical Hospital w/Outpatient Health Center...I.M. Sechenov First Moscow State Medical UniversityCompletedEffectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Erectile DysfunctionErectile Dysfunction | Impotence, VasculogenicRussian Federation
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National Taiwan University HospitalAbbottUnknown
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University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
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Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
Clinical Trials on Low intensity linear focused shockwave device ('Renova')
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University of MiamiDIREX SYSTEMS CORPORATIONCompletedVasculogenic Erectile DysfunctionUnited States
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InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
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University of VirginiaDIREX SYSTEMS CORPORATIONWithdrawnVasculogenic Erectile Dysfunction
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Hospital for Special Surgery, New YorkActive, not recruiting
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Chang Gung Memorial HospitalUnknown
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Virginia Polytechnic Institute and State UniversityNot yet recruiting
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Virginia Polytechnic Institute and State UniversitySalem VA Medical Center; Washington DC VA Medical CenterNot yet recruitingChronic Pain | Opioid Use Disorder | Anxiety DisorderUnited States
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Virginia Polytechnic Institute and State UniversityEnrolling by invitation
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Institute for the Study of Urological Diseases,...CompletedChronic Pelvic Pain Syndrome | Chronic Non-bacterial Prostatitis Type IIIBGreece
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Chongqing Medical UniversityRecruitingThe Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral NeuropathyPainful Diabetic NeuropathyChina