Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, Penile implant, Titan
Brief summary
The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
Interventions
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate User Acceptance of Titan® OTR - Question 1 | 3 months post-surgery | Subject Satisfaction - overall function |
| Evaluate User Acceptance of Titan® OTR - Question 2 | 3 months post-surgery | Subject Satisfaction - soft enough to conceal when deflated |
| Evaluate User Acceptance of Titan® OTR - Question 3 | 3 months post-surgery | Subject Satisfaction - ease of locating the deflation touch pads |
| Evaluate User Acceptance of Titan® OTR - Question 4 | 3 months post-surgery | Subject Satisfaction - ease of inflation |
| Evaluate User Acceptance of Titan® OTR - Question 5 | 3 months post-surgery | Subject Satisfaction - ease of deflation |
| Evaluate User Acceptance of Titan® OTR - Question 6 | 3 months post-surgery | Subject Satisfaction - hardness of erection when inflated |
| Evaluate User Acceptance of Titan® OTR - Question 8 | 3 months post-surgery | Subject Satisfaction - length when inflated |
| Evaluate User Acceptance of Titan® OTR - Question 9 | 3 months post-surgery | 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 | 3 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 2 | At implant | 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 | At implant | The subject was easily able to accommodate the OTR pump? |
| Evaluate User Acceptance of Titan® OTR - Question 7 | 3 months post-surgery | Subject Satisfaction - width when inflated |
| 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 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 the Ease of Training for Titan® OTR - Question 6 | 6 weeks | The OTR pump was easy to use at 1st cycling? |
| 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? |
| Assess the Ease of Training for Titan® OTR - Question 9 | 6 weeks | How likely the subject will need continued training or retraining? |
| Assess Partner Satisfaction (Where Applicable) | Baseline | 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 the Ease of Implant of the Titan® OTR Question 1 | At implant | Titan OTR pre-implant product preparation was straightforward/simple? |
Countries
Canada, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Titan® OTR IPP Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)
Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. | 124 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Did not meet enrollment criteria | 2 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Not implanted with study device | 9 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Titan® OTR IPP |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 61.0 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment Canada | 27 participants |
| Region of Enrollment United Kingdom | 26 participants |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 113 |
| serious Total, serious adverse events | 10 / 113 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Assess the Ease of Deflation of the Titan® OTR Pump | 70.8 % of participants meeting success criter |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Ease of erection | 22.9 units on a scale | Standard Deviation 28.3 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Erectile function | 18.1 units on a scale | Standard Deviation 23.9 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Pleasure from sexual activity | 35.6 units on a scale | Standard Deviation 29.8 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Satisfaction with orgasm | 35.2 units on a scale | Standard Deviation 33.2 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Confidence to complete sexual activity | 23.2 units on a scale | Standard Deviation 27 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Ease of erection | 67.8 units on a scale | Standard Deviation 31.3 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Erectile function | 74.8 units on a scale | Standard Deviation 20.4 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Pleasure from sexual activity | 64.7 units on a scale | Standard Deviation 24.8 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Satisfaction with orgasm | 62.2 units on a scale | Standard Deviation 29.2 |
| Titan® OTR IPP | Assess Partner Satisfaction (Where Applicable) | Confidence to complete sexual activity | 71.2 units on a scale | Standard Deviation 28.4 |
Secondary
Assess the Ease of Implant of the Titan® OTR Question 1
Titan OTR pre-implant product preparation was straightforward/simple?
Time frame: At implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR Question 1 | Completely disagree | 0.0 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR Question 1 | Somewhat disagree | 0.0 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR Question 1 | Neutral | 2.7 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR Question 1 | Somewhat agree | 22.1 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR Question 1 | Completely agree | 75.2 percentage of responses |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 2 | Somewhat disagree | 0.0 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 2 | Neutral | 10.6 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 2 | Somewhat agree | 40.7 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 2 | Completely agree | 48.7 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 2 | Completely disagree | 0.0 percentage of responses |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 3 | Completely disagree | 0.0 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 3 | Somewhat disagree | 0.0 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 3 | Neutral | 2.7 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 3 | Somewhat agree | 20.4 percentage of responses |
| Titan® OTR IPP | Assess the Ease of Implant of the Titan® OTR - Question 3 | Completely agree | 77.0 percentage of responses |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 1 | Not at all | 0.0 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 1 | A little | 0.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 1 | Somewhat | 4.6 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 1 | Very | 13.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 1 | Extremely | 80.6 percentage of participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 2 | Very | 26.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 2 | Not at all | 1.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 2 | A little | 3.7 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 2 | Somewhat | 9.3 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 2 | Extremely | 58.3 percentage of participants |
Secondary
Assess the Ease of Training for Titan® OTR - Question 3
It was easy for the subject to inflate the device?
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 3 | Not at all | 1.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 3 | A little | 0.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 3 | Somewhat | 4.6 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 3 | Very | 17.6 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 3 | Extremely | 75.0 percentage of participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 4 | Not at all | 2.8 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 4 | A little | 1.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 4 | Somewhat | 10.2 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 4 | Very | 25.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 4 | Extremely | 59.3 percentage of participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 5 | Not at all | 1.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 5 | A little | 1.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 5 | Somewhat | 16.7 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 5 | Very | 16.7 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 5 | Extremely | 63.0 percentage of participants |
Secondary
Assess the Ease of Training for Titan® OTR - Question 6
The OTR pump was easy to use at 1st cycling?
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 6 | Not at all | 1.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 6 | A little | 5.6 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 6 | Somewhat | 8.3 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 6 | Very | 21.3 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 6 | Extremely | 63.0 percentage of participants |
Secondary
Assess the Ease of Training for Titan® OTR - Question 7
The subject likes the OTR pump?
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 7 | Not at all | 0.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 7 | A little | 3.7 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 7 | Somewhat | 13.0 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 7 | Very | 20.4 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 7 | Extremely | 62.0 percentage of participants |
Secondary
Assess the Ease of Training for Titan® OTR - Question 8
How easy was it for the subject to learn?
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 8 | Not at all | 2.8 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 8 | A little | 8.4 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 8 | Somewhat | 7.5 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 8 | Very | 29.9 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 8 | Extremely | 51.4 percentage of participants |
Secondary
Assess the Ease of Training for Titan® OTR - Question 9
How likely the subject will need continued training or retraining?
Time frame: 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 9 | Not at all | 5.6 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 9 | A little | 10.3 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 9 | Somewhat | 11.2 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 9 | Very | 25.2 percentage of participants |
| Titan® OTR IPP | Assess the Ease of Training for Titan® OTR - Question 9 | Extremely | 47.7 percentage of participants |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 1 | 90.0 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 1 | 90.6 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 1 | 72.4 % satisfactory or somewhat satisfactory |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 10 | 83.3 % responding yes and probably |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 10 | 86.7 % responding yes and probably |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 10 | 72.4 % responding yes and probably |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 2 | 82.2 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 2 | 62.8 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 2 | 76.0 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 3 | 60.6 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 3 | 77.6 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 3 | 78.2 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 4 | 86.4 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 4 | 85.3 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 4 | 68.1 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 5 | 60.6 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 5 | 70.8 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 5 | 73.3 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 6 | 91.5 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 6 | 82.0 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 6 | 93.2 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 7 | 79.8 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 7 | 86.1 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 7 | 77.6 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Time frame: 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 8 | 68.9 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Time frame: 3 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 8 | 54.3 % satisfactory or somewhat satisfactory |
Secondary
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Time frame: 6 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 8 | 61.1 % satisfactory or somewhat satisfactory |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 9 | 79.8 % responding yes and probably |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 9 | 86.5 % responding yes and probably |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Titan® OTR IPP | Evaluate User Acceptance of Titan® OTR - Question 9 | 87.8 % responding yes and probably |