Titan® One Touch Release Inflatable Penile Prosthesis

Completed · Not applicable

Conditions studied: Erectile Dysfunction

In brief

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.

Key facts

Study ID

NCT00731939

Run by

Coloplast A/S

People needed

124

Starts

2007-11-01

Expected to finish

2010-04-01

Last updated by the study team

2014-04-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory Healthcare — Altanta, Georgia, United States
• Rush Presbyterian — Chicago, Illinois, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Michigan Urology Center — Ann Arbor, Michigan, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology San Antonio — San Antonio, Texas, United States
• St Joseph's Hospital — London, Ontario, Canada
• University College London Hospital — London, UK, United Kingdom

Full record on ClinicalTrials.gov

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