Titan® One Touch Release Inflatable Penile Prosthesis

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: Inflatable Penile Prosthesis

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate User Acceptance of Titan® OTR - Question 1	Subject Satisfaction - overall function	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1	Subject Satisfaction - overall function	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1	Subject Satisfaction - overall function	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2	Subject Satisfaction - soft enough to conceal when deflated	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2	Subject Satisfaction - soft enough to conceal when deflated	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2	Subject Satisfaction - soft enough to conceal when deflated	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3	Subject Satisfaction - ease of locating the deflation touch pads	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3	Subject Satisfaction - ease of locating the deflation touch pads	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3	Subject Satisfaction - ease of locating the deflation touch pads	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4	Subject Satisfaction - ease of inflation	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4	Subject Satisfaction - ease of inflation	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4	Subject Satisfaction - ease of inflation	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5	Subject Satisfaction - ease of deflation	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5	Subject Satisfaction - ease of deflation	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5	Subject Satisfaction - ease of deflation	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6	Subject Satisfaction - hardness of erection when inflated	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6	Subject Satisfaction - hardness of erection when inflated	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6	Subject Satisfaction - hardness of erection when inflated	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7	Subject Satisfaction - width when inflated	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7	Subject Satisfaction - width when inflated	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7	Subject Satisfaction - width when inflated	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8	Subject Satisfaction - length when inflated	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8	Subject Satisfaction - length when inflated	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8	Subject Satisfaction - length when inflated	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9	Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9	Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9	Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?	12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10	Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?	3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10	Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?	6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10	Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?	12 months post-surgery
Assess the Ease of Implant of the Titan® OTR Question 1	Titan OTR pre-implant product preparation was straightforward/simple?	At implant
Assess the Ease of Implant of the Titan® OTR - Question 2	Titan OTR pre-implant product preparation was easier than your usual pump of choice?	At implant
Assess the Ease of Implant of the Titan® OTR - Question 3	The subject was easily able to accommodate the OTR pump?	At implant
Assess the Ease of Training for Titan® OTR - Question 1	It was easy for the subject to find the inflation bulb?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 2	It was easy for the subject to find the deflation touch pads?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 3	It was easy for the subject to inflate the device?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 4	It was easy for the subject to compress the deflation touch pads?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 5	Subject training with OTR pump was easier than with previous pump?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 6	The OTR pump was easy to use at 1st cycling?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 7	The subject likes the OTR pump?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 8	How easy was it for the subject to learn?	6 weeks
Assess the Ease of Training for Titan® OTR - Question 9	How likely the subject will need continued training or retraining?	6 weeks
Assess Partner Satisfaction (Where Applicable)	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.	Baseline
Assess Partner Satisfaction (Where Applicable)	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.	6 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 8, 2008
• First Posted (Estimate): August 11, 2008

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: March 7, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Penile implant; Titan
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: DK057CC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No