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Titan® One Touch Release Inflatable Penile Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00731939
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Tracking Information
First Submitted Date  ICMJE August 7, 2008
First Posted Date  ICMJE August 11, 2008
Results First Submitted Date  ICMJE September 27, 2013
Results First Posted Date  ICMJE April 14, 2014
Last Update Posted Date April 14, 2014
Study Start Date  ICMJE November 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Assess the Ease of Deflation of the Titan® OTR Pump [ Time Frame: 6 months ]
The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of "satisfactory" or "somewhat satisfactory". Other possible responses were "neither satisfactory nor unsatisfactory", "somewhat unsatisfactory", and "very unsatisfactory".
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
Assess the Ease of Deflation of the Titan® OTR Pump [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • Evaluate User Acceptance of Titan® OTR - Question 1 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - overall function
  • Evaluate User Acceptance of Titan® OTR - Question 1 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - overall function
  • Evaluate User Acceptance of Titan® OTR - Question 1 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - overall function
  • Evaluate User Acceptance of Titan® OTR - Question 2 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - soft enough to conceal when deflated
  • Evaluate User Acceptance of Titan® OTR - Question 2 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - soft enough to conceal when deflated
  • Evaluate User Acceptance of Titan® OTR - Question 2 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - soft enough to conceal when deflated
  • Evaluate User Acceptance of Titan® OTR - Question 3 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - ease of locating the deflation touch pads
  • Evaluate User Acceptance of Titan® OTR - Question 3 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - ease of locating the deflation touch pads
  • Evaluate User Acceptance of Titan® OTR - Question 3 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - ease of locating the deflation touch pads
  • Evaluate User Acceptance of Titan® OTR - Question 4 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - ease of inflation
  • Evaluate User Acceptance of Titan® OTR - Question 4 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - ease of inflation
  • Evaluate User Acceptance of Titan® OTR - Question 4 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - ease of inflation
  • Evaluate User Acceptance of Titan® OTR - Question 5 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - ease of deflation
  • Evaluate User Acceptance of Titan® OTR - Question 5 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - ease of deflation
  • Evaluate User Acceptance of Titan® OTR - Question 5 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - ease of deflation
  • Evaluate User Acceptance of Titan® OTR - Question 6 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - hardness of erection when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 6 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - hardness of erection when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 6 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - hardness of erection when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 7 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - width when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 7 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - width when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 7 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - width when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 8 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - length when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 8 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - length when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 8 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - length when inflated
  • Evaluate User Acceptance of Titan® OTR - Question 9 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
  • Evaluate User Acceptance of Titan® OTR - Question 9 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
  • Evaluate User Acceptance of Titan® OTR - Question 9 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
  • Evaluate User Acceptance of Titan® OTR - Question 10 [ Time Frame: 3 months post-surgery ]
    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
  • Evaluate User Acceptance of Titan® OTR - Question 10 [ Time Frame: 6 months post-surgery ]
    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
  • Evaluate User Acceptance of Titan® OTR - Question 10 [ Time Frame: 12 months post-surgery ]
    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
  • Assess the Ease of Implant of the Titan® OTR Question 1 [ Time Frame: At implant ]
    Titan OTR pre-implant product preparation was straightforward/simple?
  • Assess the Ease of Implant of the Titan® OTR - Question 2 [ Time Frame: At implant ]
    Titan OTR pre-implant product preparation was easier than your usual pump of choice?
  • Assess the Ease of Implant of the Titan® OTR - Question 3 [ Time Frame: At implant ]
    The subject was easily able to accommodate the OTR pump?
  • Assess the Ease of Training for Titan® OTR - Question 1 [ Time Frame: 6 weeks ]
    It was easy for the subject to find the inflation bulb?
  • Assess the Ease of Training for Titan® OTR - Question 2 [ Time Frame: 6 weeks ]
    It was easy for the subject to find the deflation touch pads?
  • Assess the Ease of Training for Titan® OTR - Question 3 [ Time Frame: 6 weeks ]
    It was easy for the subject to inflate the device?
  • Assess the Ease of Training for Titan® OTR - Question 4 [ Time Frame: 6 weeks ]
    It was easy for the subject to compress the deflation touch pads?
  • Assess the Ease of Training for Titan® OTR - Question 5 [ Time Frame: 6 weeks ]
    Subject training with OTR pump was easier than with previous pump?
  • Assess the Ease of Training for Titan® OTR - Question 6 [ Time Frame: 6 weeks ]
    The OTR pump was easy to use at 1st cycling?
  • Assess the Ease of Training for Titan® OTR - Question 7 [ Time Frame: 6 weeks ]
    The subject likes the OTR pump?
  • Assess the Ease of Training for Titan® OTR - Question 8 [ Time Frame: 6 weeks ]
    How easy was it for the subject to learn?
  • Assess the Ease of Training for Titan® OTR - Question 9 [ Time Frame: 6 weeks ]
    How likely the subject will need continued training or retraining?
  • Assess Partner Satisfaction (Where Applicable) [ Time Frame: Baseline ]
    The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.
  • Assess Partner Satisfaction (Where Applicable) [ Time Frame: 6 months ]
    The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
  • Evaluate user acceptance of Titan OTR [ Time Frame: 3,6 and 12 months ]
  • Assess the ease of implant of the Titan OTR [ Time Frame: post-surgery ]
  • Assess the ease of training for Titan OTR [ Time Frame: 6 weeks ]
  • Assess partner satisfaction (where applicable) [ Time Frame: Baseline and 6 months ]
  • Summarize all device and procedure related adverse events [ Time Frame: Study completion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Titan® One Touch Release Inflatable Penile Prosthesis
Official Title  ICMJE Titan® One Touch Release Inflatable Penile Prosthesis
Brief Summary The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Device: Inflatable Penile Prosthesis
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
Other Names:
  • Titan®
  • Titan® OTR
Study Arms  ICMJE Titan® OTR IPP
Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Intervention: Device: Inflatable Penile Prosthesis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2014)
124
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2008)
115
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00731939
Other Study ID Numbers  ICMJE DK057CC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coloplast A/S
Study Sponsor  ICMJE Coloplast A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerald Brock, MD St Joseph's Hospital
Principal Investigator: Ricardo Munarriz, MD Boston Medical Center
Principal Investigator: Lawrence Levine, MD Rush Presbyterian
Principal Investigator: Chad Ritenour, MD Emory Healthcare
Principal Investigator: LeRoy Jones, MD Urology San Antonio
Principal Investigator: William Bogache, MD Carolina Urologic Research Center
Principal Investigator: Dana Ohl, MD Michigan Urology Center
Principal Investigator: David Ralph, MD University College London Hospital
PRS Account Coloplast A/S
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP