TitanĀ® One Touch Release Inflatable Penile Prosthesis
United States124 participantsStarted 2007-11
Plain-language summary
The purpose of this study is to assess the ease of deflation of the TitanĀ® OTR pump.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Assess the Ease of Deflation of the TitanĀ® OTR Pump