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Trial record 33 of 496 for:    penis

Titan® One Touch Release Inflatable Penile Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00731939
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Intervention Device: Inflatable Penile Prosthesis
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 124
Completed 90
Not Completed 34
Reason Not Completed
Adverse Event             6
Lost to Follow-up             15
Not implanted with study device             9
Withdrawal by Subject             2
Did not meet enrollment criteria             2
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description

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 Number of Baseline Participants 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
<=18 years
0
   0.0%
Between 18 and 65 years
76
  61.3%
>=65 years
48
  38.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants
61.0  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants
Female
0
   0.0%
Male
124
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 124 participants
United States 71
Canada 27
United Kingdom 26
1.Primary Outcome
Title Assess the Ease of Deflation of the Titan® OTR Pump
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % of participants meeting success criter
70.8
2.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 1
Hide Description Subject Satisfaction - overall function
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
72.4
3.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 1
Hide Description Subject Satisfaction - overall function
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
90.6
4.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 1
Hide Description Subject Satisfaction - overall function
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
90.0
5.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 2
Hide Description Subject Satisfaction - soft enough to conceal when deflated
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
62.8
6.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 2
Hide Description Subject Satisfaction - soft enough to conceal when deflated
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
76.0
7.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 2
Hide Description Subject Satisfaction - soft enough to conceal when deflated
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
82.2
8.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 3
Hide Description Subject Satisfaction - ease of locating the deflation touch pads
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
60.6
9.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 3
Hide Description Subject Satisfaction - ease of locating the deflation touch pads
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
78.2
10.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 3
Hide Description Subject Satisfaction - ease of locating the deflation touch pads
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
77.6
11.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 4
Hide Description Subject Satisfaction - ease of inflation
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
68.1
12.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 4
Hide Description Subject Satisfaction - ease of inflation
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
85.3
13.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 4
Hide Description Subject Satisfaction - ease of inflation
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
86.4
14.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 5
Hide Description Subject Satisfaction - ease of deflation
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
60.6
15.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 5
Hide Description Subject Satisfaction - ease of deflation
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
70.8
16.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 5
Hide Description Subject Satisfaction - ease of deflation
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
73.3
17.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 6
Hide Description Subject Satisfaction - hardness of erection when inflated
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
82.0
18.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 6
Hide Description Subject Satisfaction - hardness of erection when inflated
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
91.5
19.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 6
Hide Description Subject Satisfaction - hardness of erection when inflated
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
93.2
20.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 7
Hide Description Subject Satisfaction - width when inflated
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
77.6
21.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 7
Hide Description Subject Satisfaction - width when inflated
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
86.1
22.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 7
Hide Description Subject Satisfaction - width when inflated
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
79.8
23.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 8
Hide Description Subject Satisfaction - length when inflated
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
54.3
24.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 8
Hide Description Subject Satisfaction - length when inflated
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 95
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
61.1
25.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 8
Hide Description Subject Satisfaction - length when inflated
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: % satisfactory or somewhat satisfactory
68.9
26.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % responding "yes" and "probably"
79.8
27.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % responding "yes" and "probably"
86.5
28.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 9
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: % responding "yes" and "probably"
87.8
29.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 10
Hide Description Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Time Frame 3 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: % responding "yes" and "probably"
72.4
30.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 10
Hide Description Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Time Frame 6 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: % responding "yes" and "probably"
83.3
31.Secondary Outcome
Title Evaluate User Acceptance of Titan® OTR - Question 10
Hide Description Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Time Frame 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: % responding "yes" and "probably"
86.7
32.Secondary Outcome
Title Assess the Ease of Implant of the Titan® OTR Question 1
Hide Description Titan OTR pre-implant product preparation was straightforward/simple?
Time Frame At implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of responses
Completely disagree 0.0
Somewhat disagree 0.0
Neutral 2.7
Somewhat agree 22.1
Completely agree 75.2
33.Secondary Outcome
Title Assess the Ease of Implant of the Titan® OTR - Question 2
Hide Description Titan OTR pre-implant product preparation was easier than your usual pump of choice?
Time Frame At implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of responses
Completely disagree 0.0
Somewhat disagree 0.0
Neutral 10.6
Somewhat agree 40.7
Completely agree 48.7
34.Secondary Outcome
Title Assess the Ease of Implant of the Titan® OTR - Question 3
Hide Description The subject was easily able to accommodate the OTR pump?
Time Frame At implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of responses
Completely disagree 0.0
Somewhat disagree 0.0
Neutral 2.7
Somewhat agree 20.4
Completely agree 77.0
35.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 1
Hide Description It was easy for the subject to find the inflation bulb?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 0.0
A little 0.9
Somewhat 4.6
Very 13.9
Extremely 80.6
36.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 2
Hide Description It was easy for the subject to find the deflation touch pads?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 1.9
A little 3.7
Somewhat 9.3
Very 26.9
Extremely 58.3
37.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 3
Hide Description It was easy for the subject to inflate the device?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 1.9
A little 0.9
Somewhat 4.6
Very 17.6
Extremely 75.0
38.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 4
Hide Description It was easy for the subject to compress the deflation touch pads?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 2.8
A little 1.9
Somewhat 10.2
Very 25.9
Extremely 59.3
39.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 5
Hide Description Subject training with OTR pump was easier than with previous pump?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 1.9
A little 1.9
Somewhat 16.7
Very 16.7
Extremely 63.0
40.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 6
Hide Description The OTR pump was easy to use at 1st cycling?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 1.9
A little 5.6
Somewhat 8.3
Very 21.3
Extremely 63.0
41.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 7
Hide Description The subject likes the OTR pump?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 0.9
A little 3.7
Somewhat 13.0
Very 20.4
Extremely 62.0
42.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 8
Hide Description How easy was it for the subject to learn?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 2.8
A little 8.4
Somewhat 7.5
Very 29.9
Extremely 51.4
43.Secondary Outcome
Title Assess the Ease of Training for Titan® OTR - Question 9
Hide Description How likely the subject will need continued training or retraining?
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: percentage of participants
Not at all 5.6
A little 10.3
Somewhat 11.2
Very 25.2
Extremely 47.7
44.Secondary Outcome
Title Assess Partner Satisfaction (Where Applicable)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Ease of erection 22.9  (28.3)
Erectile function 18.1  (23.9)
Pleasure from sexual activity 35.6  (29.8)
Satisfaction with orgasm 35.2  (33.2)
Confidence to complete sexual activity 23.2  (27.0)
45.Secondary Outcome
Title Assess Partner Satisfaction (Where Applicable)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description:

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 Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Ease of erection 67.8  (31.3)
Erectile function 74.8  (20.4)
Pleasure from sexual activity 64.7  (24.8)
Satisfaction with orgasm 62.2  (29.2)
Confidence to complete sexual activity 71.2  (28.4)
Time Frame 12 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Titan® OTR IPP
Hide Arm/Group Description

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.

All-Cause Mortality
Titan® OTR IPP
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Titan® OTR IPP
Affected / at Risk (%) # Events
Total   10/113 (8.85%)    
Surgical and medical procedures   
Infection   4/113 (3.54%)  4
Hematoma   2/113 (1.77%)  2
Device malfunction   2/113 (1.77%)  2
Chronic pain   1/113 (0.88%)  1
Cylinder extrusion   1/113 (0.88%)  1
Scrotal abscess   1/113 (0.88%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Titan® OTR IPP
Affected / at Risk (%) # Events
Total   14/113 (12.39%)    
Surgical and medical procedures   
Auto inflation   14/113 (12.39%)  14
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Manager
Organization: Coloplast Corp
Phone: 612-302-4990
EMail: usdibe@coloplast.com
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00731939     History of Changes
Other Study ID Numbers: DK057CC
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: September 27, 2013
Results First Posted: April 14, 2014
Last Update Posted: April 14, 2014