Study Stopped
It has been decided to improve the inclusion criteria for better study outcome
Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)
A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2011
1 active site
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
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedMarch 6, 2015
March 1, 2015
2.3 years
February 19, 2014
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
up to 6 months post treatment
Secondary Outcomes (1)
Quality of erection (Quality of Erection Questionnaire)
At screening, 1, 3 and 6 months post treatment
Study Arms (2)
Shock wave treatment
ACTIVE COMPARATORShock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)
Placebo Shock wave treatment
PLACEBO COMPARATORShock waves are prohibited to enter the body by placebo stand-off.
Interventions
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Storz Medical AGlead
Study Sites (1)
Bethanien Krankenhaus Chemnitz gemeinnützige GmbH
Chemnitz, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 21, 2014
Study Start
October 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 6, 2015
Record last verified: 2015-03