NCT03143790

Brief Summary

Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

August 7, 2014

Last Update Submit

May 4, 2017

Conditions

Erectile Function

Keywords

Erectile FunctionProstatectomyExtracorporeal Shock Wave TherapyIIEF-5

Outcome Measures

Primary Outcomes (1)

  • IIEF-5 point

    Change in IIEF-5 point

    1, 3 and 6 months

Study Arms (2)

ESWT

ACTIVE COMPARATOR

500 shockwave 3 different points on penis bilateral

Procedure: Extracorporeal Shockwave Terapy

Placebo

PLACEBO COMPARATOR

500 shockwave 3 different points on penis bilateral

Procedure: Extracorporeal Shockwave Terapy

Interventions

Extracorporeal Shockwave TerapyPROCEDURE

Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter

Also known as: ESWT
ESWTPlacebo

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly humans with a penis
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Erectil dysfunction after radical prostatectomy less than two years ago
  • IIEF - less than 20
  • EHS - less than 4

You may not qualify if:

  • drop out
  • not sexual active
  • penile prostesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUH

Odense, 5000, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patient and therapist are blind. Primary investigator is not blind. Unblinding occurs 3 months after the end of treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to active or placebo treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

August 7, 2014

First Posted

May 8, 2017

Study Start

August 1, 2014

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

All results will be published

Locations

DK(1)