NCT01274949

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 LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

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

February 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

1.4 years

First QC Date

January 9, 2011

Last Update Submit

September 13, 2011

Conditions

Erectile Dysfunction

Keywords

LI-ESWTErectile DysfunctionRadical ProstatectomyNon 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 after first visit

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:

  • Post Radical prostatectomy
  • 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

Study Sites (1)

neuro-urology unit, Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ilan Gruenwald, MD

    Rambam Medical Investigator

    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
SPONSOR

Study Record Dates

First Submitted

January 9, 2011

First Posted

January 12, 2011

Study Start

February 1, 2010

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

IL(1)