Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

May 11, 2015 updated by: Initia

A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

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

  • Israel
      • Tel-Aviv, Israel
        • The Tel-Aviv Sourasky Medical Center

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
  • Vascular 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:

  • Hormonal, neurological or psychological pathology
  • Past radical prostatectomy or extensive pelvic surgery
  • 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
  • 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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low Intensity Shockwave treatment
4 weekly sessions of Low Intensity Shockwave treatment.
Device: Low Intensity Shockwave by Renova
SHAM_COMPARATOR: Control group
Device: Sham treatment
Sham treatment that looks, sounds and feels like the real LISW treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
1, 3 and 6 months post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
1, 3 and 6 months post treatment
Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
1, 3 and 6 months post treatment
Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
1, 3 and 6 months post treatment
Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Time Frame: 1, 3 and 6 months post treatment
1, 3 and 6 months post treatment
Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment
Time Frame: 0 and 6 months post treatment
0 and 6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Initia

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

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

October 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (ESTIMATE)

March 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RENO-03-ICH

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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