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

NCT ID: NCT02068417

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Shock wave treatment

Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)

Group Type ACTIVE_COMPARATOR

shock waves

Intervention Type DEVICE

extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off

Placebo Shock wave treatment

Shock waves are prohibited to enter the body by placebo stand-off.

Group Type PLACEBO_COMPARATOR

shock waves

Intervention Type DEVICE

extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

shock waves

extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ESWT extracorporeal shock wave therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Storz Medical AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bethanien Krankenhaus Chemnitz gemeinnützige GmbH

Chemnitz, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU10/002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.