The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
Emory Healthcare
Altanta, Georgia, United States
Rush Presbyterian
Chicago, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Michigan Urology Center
Ann Arbor, Michigan, United States
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".
Time frame: 6 months
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology San Antonio
San Antonio, Texas, United States
St Joseph's Hospital
London, Ontario, Canada
University College London Hospital
London, UK, United Kingdom
Subject Satisfaction - soft enough to conceal when deflated
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: 12 months post-surgery
Assess the Ease of Implant of the Titan® OTR Question 1
Titan OTR pre-implant product preparation was straightforward/simple?
Time frame: 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?
Time frame: At implant
Assess the Ease of Implant of the Titan® OTR - Question 3
The subject was easily able to accommodate the OTR pump?
Time frame: At implant
Assess the Ease of Training for Titan® OTR - Question 1
It was easy for the subject to find the inflation bulb?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 2
It was easy for the subject to find the deflation touch pads?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 3
It was easy for the subject to inflate the device?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 4
It was easy for the subject to compress the deflation touch pads?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 5
Subject training with OTR pump was easier than with previous pump?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 6
The OTR pump was easy to use at 1st cycling?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 7
The subject likes the OTR pump?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 8
How easy was it for the subject to learn?
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 9
How likely the subject will need continued training or retraining?
Time frame: 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.
Time frame: 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.
Time frame: 6 months