Pilot Study of the Treatment of Erectile Dysfunction (ED)... | NCT02068417

Studies
Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

NCT02068417

Sponsor

Storz Medical AG

Status

Terminated

Last Update Posted

Mar 6, 2015Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Erectile Dysfunction

Interventions

shock waves

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It has been decided to improve the inclusion criteria for better study outcome

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 19, 2014

First Submission Date that Met QC Criteria

Feb 20, 2014

First Posted Date

Feb 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shock wave treatment	Active Comparator	Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)	Device: shock waves
Placebo Shock wave treatment	Placebo Comparator	Shock waves are prohibited to enter the body by placebo stand-off.	Device: shock waves

Interventions

Name	Type	Description	Arm Group Labels	Other Names
shock waves	Device	extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off	Placebo Shock wave treatment Shock wave treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)		up to 6 months post treatment

Secondary Outcomes

Measure	Description	Time Frame
Quality of erection (Quality of Erection Questionnaire)		At screening, 1, 3 and 6 months post treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Erectile dysfunction for more than 6 months
Informed consent
Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
IIEF-15 score less than 20
No neurological disease
Stable partnership for more than 3 months
Age 18-75

Exclusion Criteria:

Total prostatectomy
Another reason for ED except for vascular disorder
Clinically significant hematological disease
Heart stroke, Arrythmia during the last 6 months
Cancer during the last 5 years
Intake of antiandrogen
ED treatment with the last 7 days
IIEF score higher than, equal to 20
Previous shockwave treatment

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bethanien Krankenhaus Chemnitz gemeinnützige GmbH		Chemnitz			Germany

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074059	Extracorporeal Shockwave Therapy

Ancestor Terms

ID	Term
D014464	Ultrasonic Therapy
D003972	Diathermy
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided