CompletedNot Applicable

Titan® One Touch Release Inflatable Penile Prosthesis

United States, Canada, United Kingdom124 participantsStarted 2007-11

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

MALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the Ease of Deflation of the Titan® OTR Pump

Timeframe: 6 months

Trial details

NCT IDNCT00731939

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2013-09-27

View on ClinicalTrials.gov More Erectile Dysfunction trials