Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01442077
First received: September 26, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

Low intensity shock waves(LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply who respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.


Condition Intervention Phase
Erectile Dysfunction
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rigidity Score Questionaire- an increase of at least 1 point is considered as a treatment success [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 1
Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments.
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
Other Name: No other names
Active Comparator: arm 2
Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
Other Name: No other names
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.
Other Name: No other names
Active Comparator: arm 3
Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
Other Name: No other names
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).
Other Name: No other names
Active Comparator: arm 4
Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
Other Name: No other names
Device: Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)
Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).
Other Name: No other names

Detailed Description:

At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form, and will be asked about general medical condition and any problems related to sexual dysfunction. Than the patient's sexual function will be assessed by sexual function questionnaires. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. During the visit, the patient will be assigned to one arm of the study (random), and by the arm he belongs he will receive an explanation about this procedure. Then shall obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), then it would be the first visit. At the first visit (Visit 1) The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of the visit 1 the patient will begin treatment series and will continue to study under the arm belongs, as described: 1.Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). 2.Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission. 3.Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments). 4.Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).

Four weeks after the treatment series ends the patient will come for another visit will be asked to fill in questionnaires and perform the FMD test again.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ED for more than six months in duration.
  • At least 50% unsuccessful sexual intercourses for 4 attempts at 4 different days.
  • Previous positive experience with PDE5iswithin the past six months.
  • A minimum of two sexual attempts per month.
  • An IIEF-ED domain score of ≥19, post screening PDE5i intake.
  • An IIEF-ED domain score of ≥17 and a Rigidity score ≥ 3 , post screening with PDE5i intake
  • A Rigidity score ≥ 3 post screening PDE5i intake.
  • A stable heterosexual relationship with the same partner for more than three months.
  • Delta IIEF-ED domain score ≤5 points on visit 1 (after 1 month wash out) compared to the IIEF-ED domain score on screening.

Exclusion Criteria:

  • Prior prostate surgery.
  • Any cause of ED other than of vascular etiology.
  • Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities including Peyrone's disease.
  • Clinically significant chronic hematological disease.
  • Cardiovascular conditions that prevent sexual activity.
  • History of heart attack, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study.
  • Cancer within the past five years.
  • Use of anti-androgens, or oral or injectable androgens
  • Use of any other treatments for ED that includes oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories within seven days of screening.
  • Hormonal, neurologic, or psychological pathology.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442077

Contacts
Contact: Yoram Vardi, Prof. 00972-4-8542819 yvardi@rambam.health.gov.il
Contact: Ilan Gruenwald, MD 00972-4-8542882 i_gruenwald@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Yoram Vardi, Prof.    00972-4-8542819    yvardi@rambam.health.gov.il   
Contact: Ilan Gruenwald, MD    00972-4-8542882    i_gruenwald@rambam.health.gov.il   
Principal Investigator: Yoram Vardi, Prof. MD         
Sub-Investigator: Ilan Gruenwald, MD         
Sub-Investigator: Boaz Appel, MD         
Sub-Investigator: Suliman Nassar, MD         
Sub-Investigator: Yaron Ofer, MD         
Sub-Investigator: Omar Massarwa, RN BA         
Sub-Investigator: Ezra Gerber, RN BA         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Yoram Vardi, Prof. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01442077     History of Changes
Other Study ID Numbers: 0359-11-RMB
Study First Received: September 26, 2011
Last Updated: January 17, 2012
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on September 22, 2014