Clinical trial NCT00731939: Titan® One Touch Release Inflatable Penile Prosthesis
Official title: Titan® One Touch Release Inflatable Penile Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Penile implant
Titan
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 124
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Assess the Ease of Deflation of the Titan® OTR Pump
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate User Acceptance of Titan® OTR - Question 1
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 1
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 1
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 2
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 2
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 2
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 3
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 3
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 3
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 4
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 4
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 4
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 5
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 5
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 5
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 6
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 6
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 6
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 7
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 7
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 7
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 8
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 8
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 8
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 9
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 9
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 9
timeFrame: 12 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 10
timeFrame: 3 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 10
timeFrame: 6 months post-surgery
measure: Evaluate User Acceptance of Titan® OTR - Question 10
timeFrame: 12 months post-surgery
measure: Assess the Ease of Implant of the Titan® OTR Question 1
timeFrame: At implant
measure: Assess the Ease of Implant of the Titan® OTR - Question 2
timeFrame: At implant
measure: Assess the Ease of Implant of the Titan® OTR - Question 3
timeFrame: At implant
measure: Assess the Ease of Training for Titan® OTR - Question 1
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 2
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 3
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 4
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 5
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 6
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 7
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 8
timeFrame: 6 weeks
measure: Assess the Ease of Training for Titan® OTR - Question 9
timeFrame: 6 weeks
measure: Assess Partner Satisfaction (Where Applicable)
timeFrame: Baseline
measure: Assess Partner Satisfaction (Where Applicable)
timeFrame: 6 months
Other outcomes:
Locations:
city: Altanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Urology Center
state: Michigan
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: London
country: Canada
facility: St Joseph's Hospital
state: Ontario
city: London
country: United Kingdom
facility: University College London Hospital
state: UK
Study officials:
affiliation: St Joseph's Hospital
name: Gerald Brock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Ricardo Munarriz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush Presbyterian
name: Lawrence Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory Healthcare
name: Chad Ritenour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology San Antonio
name: LeRoy Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolina Urologic Research Center
name: William Bogache, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Urology Center
name: Dana Ohl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London Hospital
name: David Ralph, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.