NCT01274923

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2010

Completed
5 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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 18, 2011

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

January 9, 2011

Last Update Submit

May 17, 2011

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionLow Intensity Shock Wave

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile function- Erectile Function Domain

    An increase in score of 5points and above will be considered success.

    At screening and 17 weeks later at last visit

Secondary Outcomes (2)

  • Rigidity scale

    At screening and 17 weeks later at last visit

  • Flow Mediated Dilatation Technique

    At screening and 17 weeks later at last visit

Study Arms (2)

shock wave treatment

SHAM COMPARATOR
Device: "MEDISPEC" treatment probe

"MEDISPEC" Sham

SHAM COMPARATOR

"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe

Device: "MEDISPEC" treatment probe

Interventions

"MEDISPEC" treatment probeDEVICE

shock wave treatment

Also known as: Omnispec model ED1000
"MEDISPEC" Shamshock wave treatment

Eligibility Criteria

Age20 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 ≥ 3 under PDE5i therapy
  • SHIM ≤21 under PDE5i therapy
  • Non- hormonal, neurological or psychological pathology
  • Stable heterosexual relationship for more than 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Haifa District, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ilan Gruenwald, MD

CONTACT

00972544474341i_gruenwald@rambam.health.gov.il

Yoram Gruenwald, Prof

CONTACT

0097248542819yvardi@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2011

First Posted

January 12, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

May 18, 2011

Record last verified: 2011-01

Locations

IL(1)