Titan® One Touch Release Inflatable Penile Prosthesis

NCT00731939 | Completed Results

• 1 other identifier: DK057CC
• Study Type: interventional
• Target: 124
• Locations: 3 countries
• Sites: 8

Brief Summary

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Penile implant; Titan

Outcome Measures

Primary Outcomes (1)

• Assess the Ease of Deflation of the Titan® OTR Pump

  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".

  6 months

Secondary Outcomes (44)

• Evaluate User Acceptance of Titan® OTR - Question 1

  3 months post-surgery

• Evaluate User Acceptance of Titan® OTR - Question 1

  6 months post-surgery

• Evaluate User Acceptance of Titan® OTR - Question 1

  12 months post-surgery

• Evaluate User Acceptance of Titan® OTR - Question 2

  3 months post-surgery

• Evaluate User Acceptance of Titan® OTR - Question 2

  6 months post-surgery

Study Arms (1)

Titan® OTR IPP

OTHER

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

Device: Inflatable Penile Prosthesis

Interventions

Inflatable Penile Prosthesis DEVICE

Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.

Also known as: Titan®, Titan® OTR

Titan® OTR IPP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (8)

Emory Healthcare

Altanta, Georgia, 30322, United States

Location

Rush Presbyterian

Chicago, Illinois, 60612, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Michigan Urology Center

Ann Arbor, Michigan, 48109, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

University College London Hospital

London, UK, W1G 6BJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22759540 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Coloplast Corp

usdibe@coloplast.com

612-302-4990

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: April 1, 2010
• Last Updated: April 14, 2014
• Results First Posted: April 14, 2014

Record last verified: 2014-03

Locations

CA (1); GB (1); US (6)