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Trial record 4 of 37 for:    erectile dysfunction | "Erectile Dysfunction" AND "Erectile Dysfunction" | shock wave

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

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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

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.

Condition or disease Intervention/treatment
Vasculogenic Erectile Dysfunction Device: Low intensity linear focused shockwave device ('Renova')

Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Shockwaves
Low intensity linear focused shockwave device ('Renova')
Device: Low intensity linear focused shockwave device ('Renova')



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sexual Medicine clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005731


Locations
Czech Republic
Urologickaambulance
Brno, Czech Republic
Lithuania
Amber Clinic
Klaipėda, Lithuania
Netherlands
Men's Health Clinic, Amstelland Hospital
Amsterdam, Netherlands
Palestinian Territories, Occupied
Urology and Andrology Center, Red Crescent Hospital (RCH)
Ramallah, Palestinian Territories, Occupied
Sponsors and Collaborators
Initia
Investigators
Principal Investigator: Cobi Reisman, MD, PhD Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands

Publications:
Responsible Party: Initia
ClinicalTrials.gov Identifier: NCT02005731     History of Changes
Other Study ID Numbers: LSWT-004-EU
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Initia:
Low Intensity Shockwave
Extracorporeal shockwave therapy
Erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders