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

December 18, 2012 updated by: i_gruenwald, Rambam Health Care Campus

The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LI-ESWT
Low intensity shock wave treatment- 12 sessions
Device: LI-ESWT
Low intensity shock wave treatment - 12 sessions
Other Names:
  • Omnispec model ED1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IIEF-ED Domain score
Time Frame: 17 weeks after first visit
Change of 5 points and above in IIEF-ED Domain score
17 weeks after first visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rigidity scale
Time Frame: 17 weeks from visit 1
a change to 3 or 4 points in the rigidty scale
17 weeks from visit 1

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Collaborators

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

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

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • shock wave III

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.

Clinical Trials on Erectile Dysfunction

Clinical Trials on LI-ESWT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe