Trial record 6 of 64 for:    Open Studies | "Erectile Dysfunction"

Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders (LI-ESWT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medispec
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01274923
First received: January 9, 2011
Last updated: May 17, 2011
Last verified: January 2011
  Purpose

This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.


Condition Intervention Phase
Erectile Dysfunction
Device: "MEDISPEC" treatment probe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • International Index of Erectile function- Erectile Function Domain [ Time Frame: At screening and 17 weeks later at last visit ] [ Designated as safety issue: No ]
    An increase in score of 5points and above will be considered success.


Secondary Outcome Measures:
  • Rigidity scale [ Time Frame: At screening and 17 weeks later at last visit ] [ Designated as safety issue: No ]
    A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success

  • Flow Mediated Dilatation Technique [ Time Frame: At screening and 17 weeks later at last visit ] [ Designated as safety issue: No ]
    A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: shock wave treatment Device: "MEDISPEC" treatment probe
shock wave treatment
Other Name: Omnispec model ED1000
Sham Comparator: "MEDISPEC" Sham
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Device: "MEDISPEC" treatment probe
shock wave treatment
Other Name: Omnispec model ED1000

Detailed Description:

This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

  Eligibility

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

Inclusion Criteria:

  • ED of more than 6 months
  • Rigidity score ≥ 3 under PDE5i therapy
  • SHIM ≤21 under PDE5i therapy
  • Non- hormonal, neurological or psychological pathology
  • Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • Prior prostatectomy surgery
  • 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
  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: NCT01274923

Contacts
Contact: Ilan Gruenwald, MD 00972544474341 i_gruenwald@rambam.health.gov.il
Contact: Yoram Gruenwald, Prof 0097248542819 yvardi@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Ilan Gruenwald, MD    00972544474341    i_gruuenwald@rambam.health.gov.il   
Principal Investigator: Yoram Vardi, Prof.         
Sub-Investigator: Ilan Gruenwald, MD         
Sub-Investigator: Boaz Appel, MD         
Sub-Investigator: Ezra Gerber, RN         
Sub-Investigator: Omar Massarwa, RN         
Sub-Investigator: Yaron Ofer, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Medispec
  More Information

No publications provided

Responsible Party: Prof Yoram Vardi, Rambam Healthcare Campus
ClinicalTrials.gov Identifier: NCT01274923     History of Changes
Other Study ID Numbers: 0200-09-rmb europe
Study First Received: January 9, 2011
Last Updated: May 17, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Erectile dysfunction
Low Intensity Shock Wave

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 18, 2014