Trial Outcomes & Findings for Titan® One Touch Release Inflatable Penile Prosthesis (NCT NCT00731939)
NCT ID: NCT00731939
Last Updated: 2014-04-14
Results Overview
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".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
6 months
Results posted on
2014-04-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Not implanted with study device
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Did not meet enrollment criteria
|
2
|
Baseline Characteristics
Titan® One Touch Release Inflatable Penile Prosthesis
Baseline characteristics by cohort
| Measure |
Titan® OTR IPP
n=124 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe 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".
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Assess the Ease of Deflation of the Titan® OTR Pump
|
70.8 % of participants meeting success criter
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - overall function
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 1
|
72.4 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - overall function
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 1
|
90.6 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - overall function
Outcome measures
| Measure |
Titan® OTR IPP
n=90 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 1
|
90.0 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - soft enough to conceal when deflated
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 2
|
62.8 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - soft enough to conceal when deflated
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 2
|
76.0 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - soft enough to conceal when deflated
Outcome measures
| Measure |
Titan® OTR IPP
n=90 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 2
|
82.2 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - ease of locating the deflation touch pads
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 3
|
60.6 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - ease of locating the deflation touch pads
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 3
|
78.2 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - ease of locating the deflation touch pads
Outcome measures
| Measure |
Titan® OTR IPP
n=89 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 3
|
77.6 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - ease of inflation
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 4
|
68.1 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - ease of inflation
Outcome measures
| Measure |
Titan® OTR IPP
n=95 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 4
|
85.3 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - ease of inflation
Outcome measures
| Measure |
Titan® OTR IPP
n=88 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 4
|
86.4 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - ease of deflation
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 5
|
60.6 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - ease of deflation
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 5
|
70.8 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - ease of deflation
Outcome measures
| Measure |
Titan® OTR IPP
n=90 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 5
|
73.3 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - hardness of erection when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 6
|
82.0 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - hardness of erection when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 6
|
91.5 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - hardness of erection when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=89 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 6
|
93.2 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - width when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 7
|
77.6 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - width when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 7
|
86.1 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - width when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=89 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 7
|
79.8 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - length when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 8
|
54.3 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - length when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=95 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 8
|
61.1 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - length when inflated
Outcome measures
| Measure |
Titan® OTR IPP
n=90 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 8
|
68.9 % satisfactory or somewhat satisfactory
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 9
|
79.8 % responding "yes" and "probably"
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 9
|
86.5 % responding "yes" and "probably"
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Outcome measures
| Measure |
Titan® OTR IPP
n=90 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 9
|
87.8 % responding "yes" and "probably"
|
SECONDARY outcome
Timeframe: 3 months post-surgerySubject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Outcome measures
| Measure |
Titan® OTR IPP
n=94 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 10
|
72.4 % responding "yes" and "probably"
|
SECONDARY outcome
Timeframe: 6 months post-surgerySubject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Outcome measures
| Measure |
Titan® OTR IPP
n=96 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 10
|
83.3 % responding "yes" and "probably"
|
SECONDARY outcome
Timeframe: 12 months post-surgerySubject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Outcome measures
| Measure |
Titan® OTR IPP
n=90 Participants
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.
|
|---|---|
|
Evaluate User Acceptance of Titan® OTR - Question 10
|
86.7 % responding "yes" and "probably"
|
SECONDARY outcome
Timeframe: At implantTitan OTR pre-implant product preparation was straightforward/simple?
Outcome measures
| Measure |
Titan® OTR IPP
n=113 Participants
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.
|
|---|---|
|
Assess the Ease of Implant of the Titan® OTR Question 1
Completely disagree
|
0.0 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR Question 1
Somewhat disagree
|
0.0 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR Question 1
Neutral
|
2.7 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR Question 1
Somewhat agree
|
22.1 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR Question 1
Completely agree
|
75.2 percentage of responses
|
SECONDARY outcome
Timeframe: At implantTitan OTR pre-implant product preparation was easier than your usual pump of choice?
Outcome measures
| Measure |
Titan® OTR IPP
n=113 Participants
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.
|
|---|---|
|
Assess the Ease of Implant of the Titan® OTR - Question 2
Completely disagree
|
0.0 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 2
Somewhat disagree
|
0.0 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 2
Neutral
|
10.6 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 2
Somewhat agree
|
40.7 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 2
Completely agree
|
48.7 percentage of responses
|
SECONDARY outcome
Timeframe: At implantThe subject was easily able to accommodate the OTR pump?
Outcome measures
| Measure |
Titan® OTR IPP
n=113 Participants
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.
|
|---|---|
|
Assess the Ease of Implant of the Titan® OTR - Question 3
Completely disagree
|
0.0 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 3
Somewhat disagree
|
0.0 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 3
Neutral
|
2.7 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 3
Somewhat agree
|
20.4 percentage of responses
|
|
Assess the Ease of Implant of the Titan® OTR - Question 3
Completely agree
|
77.0 percentage of responses
|
SECONDARY outcome
Timeframe: 6 weeksIt was easy for the subject to find the inflation bulb?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 1
Not at all
|
0.0 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 1
A little
|
0.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 1
Somewhat
|
4.6 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 1
Very
|
13.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 1
Extremely
|
80.6 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksIt was easy for the subject to find the deflation touch pads?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 2
Not at all
|
1.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 2
A little
|
3.7 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 2
Somewhat
|
9.3 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 2
Very
|
26.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 2
Extremely
|
58.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksIt was easy for the subject to inflate the device?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 3
Not at all
|
1.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 3
A little
|
0.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 3
Somewhat
|
4.6 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 3
Very
|
17.6 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 3
Extremely
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksIt was easy for the subject to compress the deflation touch pads?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 4
Not at all
|
2.8 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 4
A little
|
1.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 4
Somewhat
|
10.2 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 4
Very
|
25.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 4
Extremely
|
59.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksSubject training with OTR pump was easier than with previous pump?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 5
Not at all
|
1.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 5
A little
|
1.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 5
Somewhat
|
16.7 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 5
Very
|
16.7 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 5
Extremely
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksThe OTR pump was easy to use at 1st cycling?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 6
Not at all
|
1.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 6
A little
|
5.6 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 6
Somewhat
|
8.3 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 6
Very
|
21.3 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 6
Extremely
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksThe subject likes the OTR pump?
Outcome measures
| Measure |
Titan® OTR IPP
n=108 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 7
Not at all
|
0.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 7
A little
|
3.7 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 7
Somewhat
|
13.0 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 7
Very
|
20.4 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 7
Extremely
|
62.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksHow easy was it for the subject to learn?
Outcome measures
| Measure |
Titan® OTR IPP
n=107 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 8
Somewhat
|
7.5 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 8
Not at all
|
2.8 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 8
A little
|
8.4 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 8
Very
|
29.9 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 8
Extremely
|
51.4 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeksHow likely the subject will need continued training or retraining?
Outcome measures
| Measure |
Titan® OTR IPP
n=107 Participants
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.
|
|---|---|
|
Assess the Ease of Training for Titan® OTR - Question 9
Not at all
|
5.6 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 9
A little
|
10.3 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 9
Somewhat
|
11.2 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 9
Very
|
25.2 percentage of participants
|
|
Assess the Ease of Training for Titan® OTR - Question 9
Extremely
|
47.7 percentage of participants
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Titan® OTR IPP
n=59 Participants
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.
|
|---|---|
|
Assess Partner Satisfaction (Where Applicable)
Ease of erection
|
22.9 units on a scale
Standard Deviation 28.3
|
|
Assess Partner Satisfaction (Where Applicable)
Erectile function
|
18.1 units on a scale
Standard Deviation 23.9
|
|
Assess Partner Satisfaction (Where Applicable)
Pleasure from sexual activity
|
35.6 units on a scale
Standard Deviation 29.8
|
|
Assess Partner Satisfaction (Where Applicable)
Satisfaction with orgasm
|
35.2 units on a scale
Standard Deviation 33.2
|
|
Assess Partner Satisfaction (Where Applicable)
Confidence to complete sexual activity
|
23.2 units on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Titan® OTR IPP
n=39 Participants
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.
|
|---|---|
|
Assess Partner Satisfaction (Where Applicable)
Ease of erection
|
67.8 units on a scale
Standard Deviation 31.3
|
|
Assess Partner Satisfaction (Where Applicable)
Erectile function
|
74.8 units on a scale
Standard Deviation 20.4
|
|
Assess Partner Satisfaction (Where Applicable)
Pleasure from sexual activity
|
64.7 units on a scale
Standard Deviation 24.8
|
|
Assess Partner Satisfaction (Where Applicable)
Satisfaction with orgasm
|
62.2 units on a scale
Standard Deviation 29.2
|
|
Assess Partner Satisfaction (Where Applicable)
Confidence to complete sexual activity
|
71.2 units on a scale
Standard Deviation 28.4
|
Adverse Events
Titan® OTR IPP
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Titan® OTR IPP
n=113 participants at risk
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.
|
|---|---|
|
Surgical and medical procedures
Infection
|
3.5%
4/113 • Number of events 4 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
|
Surgical and medical procedures
Hematoma
|
1.8%
2/113 • Number of events 2 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
|
Surgical and medical procedures
Device malfunction
|
1.8%
2/113 • Number of events 2 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
|
Surgical and medical procedures
Chronic pain
|
0.88%
1/113 • Number of events 1 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
|
Surgical and medical procedures
Cylinder extrusion
|
0.88%
1/113 • Number of events 1 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
|
Surgical and medical procedures
Scrotal abscess
|
0.88%
1/113 • Number of events 1 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
Other adverse events
| Measure |
Titan® OTR IPP
n=113 participants at risk
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.
|
|---|---|
|
Surgical and medical procedures
Auto inflation
|
12.4%
14/113 • Number of events 14 • 12 months
The analysis is based on the per protocol population (n=113). Of 124 consented subjects, nine (9) subjects did not meet inclusion/exclusion criteria and were not implanted with the study device. Two (2) subjects did not meet enrollment criteria and these two subjects were not followed for safety or efficacy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place