The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders (LI-ESWT)

This study has been completed.
Sponsor:
Collaborator:
Medispec
Information provided by (Responsible Party):
i_gruenwald, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01272297
First received: December 14, 2010
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.


Condition Intervention Phase
Erectile Dysfunction
Device: LI-ESWT
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • IIEF-ED Domain score [ Time Frame: 17 weeks after first visit ] [ Designated as safety issue: No ]
    Change of 5 points and above in IIEF-ED Domain score


Secondary Outcome Measures:
  • rigidity scale [ Time Frame: 17 weeks from visit 1 ] [ Designated as safety issue: No ]
    a change to 3 or 4 points in the rigidty scale


Enrollment: 29
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LI-ESWT
Low intensity shock wave treatment- 12 sessions
Device: LI-ESWT
Low intensity shock wave treatment - 12 sessions
Other Name: Omnispec model ED1000

Detailed Description:

We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ED of more than 6 months
  • Rigidity score ≤ 2 during PDE5i therapy
  • Stable heterosexual relationship for more than 3 months
  • Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion Criteria:

  • Prior surgery or radiotherapy in pelvic region
  • Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Cardiovascular conditions that prevent sexual activity
  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: NCT01272297

Sponsors and Collaborators
Rambam Health Care Campus
Medispec
Investigators
Principal Investigator: Yoram Vardi, Prof Rambam Health Care Campus
Study Director: Ilan Gruenwald, MD Rambam Health Care Campus
Study Director: Boaz Appel, MD Rambam Health Care Campus
Study Director: Ezra Gerber, RN Rambam Health Care Campus
Study Director: Yaron Ofer, MD Rambam Health Care Campus
Study Director: Omar Massarwa, RN Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: i_gruenwald, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01272297     History of Changes
Other Study ID Numbers: shock wave III
Study First Received: December 14, 2010
Last Updated: December 18, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
LI-ESWT
Erectile Dysfunction
Non PDE5 inhibitor responders
Shock wave

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

ClinicalTrials.gov processed this record on August 21, 2014