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

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:

  1. Good general health
  2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
  3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
  4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
  5. Stable sexual relationship for at least 3 months prior to treatment
  6. Minimum of two sexual attempts per month

Exclusion Criteria:

  1. Hormonal, neurological or psychological pathology
  2. Past radical prostatectomy or extensive pelvic surgery
  3. Recovering from cancer during last year
  4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
  5. Clinically significant chronic hematological disease
  6. Anti-androgens, oral or injectable androgens
  7. Past radiotherapy treatment of the pelvic region
  8. 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.

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

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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