Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2007-11-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Titan® OTR IPP
Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
Interventions
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Inflatable Penile Prosthesis
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Gerald Brock, MD
Role: PRINCIPAL_INVESTIGATOR
St Joseph's Hospital
Ricardo Munarriz, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Lawrence Levine, MD
Role: PRINCIPAL_INVESTIGATOR
Rush Presbyterian
Chad Ritenour, MD
Role: PRINCIPAL_INVESTIGATOR
Emory Healthcare
LeRoy Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Urology San Antonio
William Bogache, MD
Role: PRINCIPAL_INVESTIGATOR
Carolina Urologic Research Center
Dana Ohl, MD
Role: PRINCIPAL_INVESTIGATOR
Michigan Urology Center
David Ralph, MD
Role: PRINCIPAL_INVESTIGATOR
University College London Hospital
Locations
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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
Countries
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References
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Ohl DA, Brock G, Ralph D, Bogache W, Jones L, Munarriz R, Levine L, Ritenour C. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast titan one touch release three-piece inflatable penile prosthesis. J Sex Med. 2012 Sep;9(9):2467-74. doi: 10.1111/j.1743-6109.2012.02819.x. Epub 2012 Jul 3.
Other Identifiers
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DK057CC
Identifier Type: -
Identifier Source: org_study_id
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