Status:
COMPLETED
Titan® One Touch Release Inflatable Penile Prosthesis
Lead Sponsor:
Coloplast A/S
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
Eligibility Criteria
Inclusion
- Participant has an estimated life expectancy of more than 5 years
- Participant has been diagnosed with erectile dysfunction (impotence)
- participant is willing to have the Titan OTR IPP implanted
- Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol
Exclusion
- Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
- Participant had a previous penile prosthesis or prior penile enlargement surgeries
- Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
- Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
- Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability
- Participant does not have the manual dexterity or mental ability to operate the pump
- Participant has chordee or priapism
- Participant has penile sensory neuropathy
- Participant has serious bleeding disorder
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00731939
Start Date
November 1 2007
End Date
April 1 2010
Last Update
April 14 2014
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory Healthcare
Altanta, Georgia, United States, 30322
2
Rush Presbyterian
Chicago, Illinois, United States, 60612
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Michigan Urology Center
Ann Arbor, Michigan, United States, 48109