Titan® One Touch Release Inflatable Penile Prosthesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00731939
First received: August 7, 2008
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Erectile Dysfunction
Device: Inflatable Penile Prosthesis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Titan® One Touch Release Inflatable Penile Prosthesis

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Assess the Ease of Deflation of the Titan® OTR Pump [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • Evaluate User Acceptance of Titan® OTR - Question 1 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - overall function

  • Evaluate User Acceptance of Titan® OTR - Question 1 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - overall function

  • Evaluate User Acceptance of Titan® OTR - Question 1 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - overall function

  • Evaluate User Acceptance of Titan® OTR - Question 2 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - soft enough to conceal when deflated

  • Evaluate User Acceptance of Titan® OTR - Question 2 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - soft enough to conceal when deflated

  • Evaluate User Acceptance of Titan® OTR - Question 2 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - soft enough to conceal when deflated

  • Evaluate User Acceptance of Titan® OTR - Question 3 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of locating the deflation touch pads

  • Evaluate User Acceptance of Titan® OTR - Question 3 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of locating the deflation touch pads

  • Evaluate User Acceptance of Titan® OTR - Question 3 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of locating the deflation touch pads

  • Evaluate User Acceptance of Titan® OTR - Question 4 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of inflation

  • Evaluate User Acceptance of Titan® OTR - Question 4 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of inflation

  • Evaluate User Acceptance of Titan® OTR - Question 4 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of inflation

  • Evaluate User Acceptance of Titan® OTR - Question 5 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of deflation

  • Evaluate User Acceptance of Titan® OTR - Question 5 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of deflation

  • Evaluate User Acceptance of Titan® OTR - Question 5 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - ease of deflation

  • Evaluate User Acceptance of Titan® OTR - Question 6 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - hardness of erection when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 6 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - hardness of erection when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 6 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - hardness of erection when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 7 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - width when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 7 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - width when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 7 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - width when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 8 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - length when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 8 [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - length when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 8 [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    Subject Satisfaction - length when inflated

  • Evaluate User Acceptance of Titan® OTR - Question 9 [ Time Frame: 3 months post-surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Titan OTR pre-implant product preparation was straightforward/simple?

  • Assess the Ease of Implant of the Titan® OTR - Question 2 [ Time Frame: At implant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The subject was easily able to accommodate the OTR pump?

  • Assess the Ease of Training for Titan® OTR - Question 1 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    It was easy for the subject to inflate the device?

  • Assess the Ease of Training for Titan® OTR - Question 4 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The OTR pump was easy to use at 1st cycling?

  • Assess the Ease of Training for Titan® OTR - Question 7 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The subject likes the OTR pump?

  • Assess the Ease of Training for Titan® OTR - Question 8 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    How easy was it for the subject to learn?

  • Assess the Ease of Training for Titan® OTR - Question 9 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    How likely the subject will need continued training or retraining?

  • Assess Partner Satisfaction (Where Applicable) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 124
Study Start Date: November 2007
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Titan® OTR IPP
Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731939

Locations
United States, Georgia
Emory Healthcare
Altanta, Georgia, United States, 30322
United States, Illinois
Rush Presbyterian
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan Urology Center
Ann Arbor, Michigan, United States, 48109
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Urology San Antonio
San Antonio, Texas, United States, 78229
Canada, Ontario
St Joseph's Hospital
London, Ontario, Canada, N6A 4V2
United Kingdom
University College London Hospital
London, UK, United Kingdom, W1G 6BJ
Sponsors and Collaborators
Coloplast A/S
Investigators
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
  More Information

Publications:
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00731939     History of Changes
Other Study ID Numbers: DK057CC
Study First Received: August 7, 2008
Results First Received: September 27, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Coloplast A/S:
Erectile Dysfunction
Penile implant
Titan

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014