Titan® One Touch Release Inflatable Penile Prosthesis

Coloplast

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Inflatable Penile Prosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731939

DK057CC

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Titan® OTR IPP

Other group

Description:

Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)

Treatment:

Device: Inflatable Penile Prosthesis