Titan® One Touch Release Inflatable Penile Prosthesis
- Conditions
- Erectile Dysfunction
- Interventions
- Device: Inflatable Penile Prosthesis
- Registration Number
- NCT00731939
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 124
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Titan® OTR IPP Inflatable Penile Prosthesis Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
- Primary Outcome Measures
Name Time Method Assess the Ease of Deflation of the Titan® OTR Pump 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".
- Secondary Outcome Measures
Name Time Method Evaluate User Acceptance of Titan® OTR - Question 8 12 months post-surgery Subject Satisfaction - length when inflated
Evaluate User Acceptance of Titan® OTR - Question 1 12 months post-surgery Subject Satisfaction - overall function
Evaluate User Acceptance of Titan® OTR - Question 2 12 months post-surgery Subject Satisfaction - soft enough to conceal when deflated
Assess the Ease of Training for Titan® OTR - Question 6 6 weeks The OTR pump was easy to use at 1st cycling?
Evaluate User Acceptance of Titan® OTR - Question 3 12 months post-surgery Subject Satisfaction - ease of locating the deflation touch pads
Evaluate User Acceptance of Titan® OTR - Question 7 12 months post-surgery Subject Satisfaction - width when inflated
Evaluate User Acceptance of Titan® OTR - Question 10 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 At implant Titan OTR pre-implant product preparation was straightforward/simple?
Assess the Ease of Training for Titan® OTR - Question 7 6 weeks The subject likes the OTR pump?
Assess the Ease of Training for Titan® OTR - Question 8 6 weeks How easy was it for the subject to learn?
Evaluate User Acceptance of Titan® OTR - Question 4 12 months post-surgery Subject Satisfaction - ease of inflation
Evaluate User Acceptance of Titan® OTR - Question 5 12 months post-surgery Subject Satisfaction - ease of deflation
Evaluate User Acceptance of Titan® OTR - Question 6 12 months post-surgery Subject Satisfaction - hardness of erection when inflated
Assess the Ease of Implant of the Titan® OTR - Question 3 At implant The subject was easily able to accommodate the OTR pump?
Assess the Ease of Training for Titan® OTR - Question 1 6 weeks It was easy for the subject to find the inflation bulb?
Assess the Ease of Training for Titan® OTR - Question 2 6 weeks It was easy for the subject to find the deflation touch pads?
Assess the Ease of Training for Titan® OTR - Question 9 6 weeks How likely the subject will need continued training or retraining?
Assess the Ease of Training for Titan® OTR - Question 3 6 weeks It was easy for the subject to inflate the device?
Assess the Ease of Training for Titan® OTR - Question 4 6 weeks It was easy for the subject to compress the deflation touch pads?
Assess the Ease of Training for Titan® OTR - Question 5 6 weeks Subject training with OTR pump was easier than with previous pump?
Assess Partner Satisfaction (Where Applicable) 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.
Evaluate User Acceptance of Titan® OTR - Question 9 12 months post-surgery Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Assess the Ease of Implant of the Titan® OTR - Question 2 At implant Titan OTR pre-implant product preparation was easier than your usual pump of choice?
Trial Locations
- Locations (8)
University College London Hospital
🇬🇧London, UK, United Kingdom
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Rush Presbyterian
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Emory Healthcare
🇺🇸Altanta, Georgia, United States
Michigan Urology Center
🇺🇸Ann Arbor, Michigan, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
St Joseph's Hospital
🇨🇦London, Ontario, Canada