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Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction (LISW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005731
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Initia

Tracking Information
First Submitted Date December 4, 2013
First Posted Date December 9, 2013
Last Update Posted Date June 11, 2014
Study Start Date November 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2013)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2013)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction
Official Title 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
Brief Summary This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Sexual Medicine clinic
Condition Vasculogenic Erectile Dysfunction
Intervention Device: Low intensity linear focused shockwave device ('Renova')
Study Groups/Cohorts Shockwaves
Low intensity linear focused shockwave device ('Renova')
Intervention: Device: Low intensity linear focused shockwave device ('Renova')
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2013)
58
Original Actual Enrollment Same as current
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czech Republic,   Lithuania,   Netherlands,   Palestinian Territories, Occupied
Removed Location Countries  
 
Administrative Information
NCT Number NCT02005731
Other Study ID Numbers LSWT-004-EU
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Initia
Study Sponsor Initia
Collaborators Not Provided
Investigators
Principal Investigator: Cobi Reisman, MD, PhD Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands
PRS Account Initia
Verification Date June 2014