NCT01272297

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

December 14, 2010

Last Update Submit

December 18, 2012

Conditions

Erectile Dysfunction

Keywords

LI-ESWTErectile DysfunctionNon PDE5 inhibitor respondersShock wave

Outcome Measures

Primary Outcomes (1)

  • IIEF-ED Domain score

    Change of 5 points and above in IIEF-ED Domain score

    17 weeks after first visit

Secondary Outcomes (1)

  • rigidity scale

    17 weeks from visit 1

Study Arms (1)

LI-ESWT

EXPERIMENTAL

Low intensity shock wave treatment- 12 sessions

Device: LI-ESWT

Interventions

LI-ESWTDEVICE

Low intensity shock wave treatment - 12 sessions

Also known as: Omnispec model ED1000
LI-ESWT

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Yoram Vardi, Prof

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 14, 2010

First Posted

January 7, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

December 19, 2012

Record last verified: 2012-12