Titan® One Touch Release Inflatable Penile Prosthesis

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00731939
• Collaborator: (none)
• Enrollment: 124
• Locations: 8
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Device: Inflatable Penile Prosthesis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Titan® One Touch Release Inflatable Penile Prosthesis
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Titan® OTR IPP Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)	Device: Inflatable Penile Prosthesis; Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.; Other Names: Titan® Titan® OTR

Outcome Measures

Primary Outcome Measures

1. Assess the Ease of Deflation of the Titan® OTR Pump [6 months]

   The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of "satisfactory" or "somewhat satisfactory". Other possible responses were "neither satisfactory nor unsatisfactory", "somewhat unsatisfactory", and "very unsatisfactory".

Secondary Outcome Measures

1. Evaluate User Acceptance of Titan® OTR - Question 1 [3 months post-surgery]

   Subject Satisfaction - overall function

2. Evaluate User Acceptance of Titan® OTR - Question 1 [6 months post-surgery]

   Subject Satisfaction - overall function

3. Evaluate User Acceptance of Titan® OTR - Question 1 [12 months post-surgery]

   Subject Satisfaction - overall function

4. Evaluate User Acceptance of Titan® OTR - Question 2 [3 months post-surgery]

   Subject Satisfaction - soft enough to conceal when deflated

5. Evaluate User Acceptance of Titan® OTR - Question 2 [6 months post-surgery]

   Subject Satisfaction - soft enough to conceal when deflated

6. Evaluate User Acceptance of Titan® OTR - Question 2 [12 months post-surgery]

   Subject Satisfaction - soft enough to conceal when deflated

7. Evaluate User Acceptance of Titan® OTR - Question 3 [3 months post-surgery]

   Subject Satisfaction - ease of locating the deflation touch pads

8. Evaluate User Acceptance of Titan® OTR - Question 3 [6 months post-surgery]

   Subject Satisfaction - ease of locating the deflation touch pads

9. Evaluate User Acceptance of Titan® OTR - Question 3 [12 months post-surgery]

   Subject Satisfaction - ease of locating the deflation touch pads

10. Evaluate User Acceptance of Titan® OTR - Question 4 [3 months post-surgery]

    Subject Satisfaction - ease of inflation

11. Evaluate User Acceptance of Titan® OTR - Question 4 [6 months post-surgery]

    Subject Satisfaction - ease of inflation

12. Evaluate User Acceptance of Titan® OTR - Question 4 [12 months post-surgery]

    Subject Satisfaction - ease of inflation

13. Evaluate User Acceptance of Titan® OTR - Question 5 [3 months post-surgery]

    Subject Satisfaction - ease of deflation

14. Evaluate User Acceptance of Titan® OTR - Question 5 [6 months post-surgery]

    Subject Satisfaction - ease of deflation

15. Evaluate User Acceptance of Titan® OTR - Question 5 [12 months post-surgery]

    Subject Satisfaction - ease of deflation

16. Evaluate User Acceptance of Titan® OTR - Question 6 [3 months post-surgery]

    Subject Satisfaction - hardness of erection when inflated

17. Evaluate User Acceptance of Titan® OTR - Question 6 [6 months post-surgery]

    Subject Satisfaction - hardness of erection when inflated

18. Evaluate User Acceptance of Titan® OTR - Question 6 [12 months post-surgery]

    Subject Satisfaction - hardness of erection when inflated

19. Evaluate User Acceptance of Titan® OTR - Question 7 [3 months post-surgery]

    Subject Satisfaction - width when inflated

20. Evaluate User Acceptance of Titan® OTR - Question 7 [6 months post-surgery]

    Subject Satisfaction - width when inflated

21. Evaluate User Acceptance of Titan® OTR - Question 7 [12 months post-surgery]

    Subject Satisfaction - width when inflated

22. Evaluate User Acceptance of Titan® OTR - Question 8 [3 months post-surgery]

    Subject Satisfaction - length when inflated

23. Evaluate User Acceptance of Titan® OTR - Question 8 [6 months post-surgery]

    Subject Satisfaction - length when inflated

24. Evaluate User Acceptance of Titan® OTR - Question 8 [12 months post-surgery]

    Subject Satisfaction - length when inflated

25. 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?

26. Evaluate User Acceptance of Titan® OTR - Question 9 [6 months post-surgery]

    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?

27. Evaluate User Acceptance of Titan® OTR - Question 9 [12 months post-surgery]

    Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?

28. 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?

29. Evaluate User Acceptance of Titan® OTR - Question 10 [6 months post-surgery]

    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?

30. Evaluate User Acceptance of Titan® OTR - Question 10 [12 months post-surgery]

    Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?

31. Assess the Ease of Implant of the Titan® OTR Question 1 [At implant]

    Titan OTR pre-implant product preparation was straightforward/simple?

32. 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?

33. Assess the Ease of Implant of the Titan® OTR - Question 3 [At implant]

    The subject was easily able to accommodate the OTR pump?

34. Assess the Ease of Training for Titan® OTR - Question 1 [6 weeks]

    It was easy for the subject to find the inflation bulb?

35. Assess the Ease of Training for Titan® OTR - Question 2 [6 weeks]

    It was easy for the subject to find the deflation touch pads?

36. Assess the Ease of Training for Titan® OTR - Question 3 [6 weeks]

    It was easy for the subject to inflate the device?

37. Assess the Ease of Training for Titan® OTR - Question 4 [6 weeks]

    It was easy for the subject to compress the deflation touch pads?

38. Assess the Ease of Training for Titan® OTR - Question 5 [6 weeks]

    Subject training with OTR pump was easier than with previous pump?

39. Assess the Ease of Training for Titan® OTR - Question 6 [6 weeks]

    The OTR pump was easy to use at 1st cycling?

40. Assess the Ease of Training for Titan® OTR - Question 7 [6 weeks]

    The subject likes the OTR pump?

41. Assess the Ease of Training for Titan® OTR - Question 8 [6 weeks]

    How easy was it for the subject to learn?

42. Assess the Ease of Training for Titan® OTR - Question 9 [6 weeks]

    How likely the subject will need continued training or retraining?

43. 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.

44. Assess Partner Satisfaction (Where Applicable) [6 months]

    The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory Healthcare	Altanta	Georgia	United States	30322
2	Rush Presbyterian	Chicago	Illinois	United States	60612
3	Boston Medical Center	Boston	Massachusetts	United States	02118
4	Michigan Urology Center	Ann Arbor	Michigan	United States	48109
5	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
6	Urology San Antonio	San Antonio	Texas	United States	78229
7	St Joseph's Hospital	London	Ontario	Canada	N6A 4V2
8	University College London Hospital	London	UK	United Kingdom	W1G 6BJ

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Gerald Brock, MD, St Joseph's Hospital
• Principal Investigator: Ricardo Munarriz, MD, Boston Medical Center
• Principal Investigator: Lawrence Levine, MD, Rush Presbyterian
• Principal Investigator: Chad Ritenour, MD, Emory Healthcare
• Principal Investigator: LeRoy Jones, MD, Urology San Antonio
• Principal Investigator: William Bogache, MD, Carolina Urologic Research Center
• Principal Investigator: Dana Ohl, MD, Michigan Urology Center
• Principal Investigator: David Ralph, MD, University College London Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT00731939
• Other Study ID Numbers: DK057CC
• First Posted: Aug 11, 2008
• Last Update Posted: Apr 14, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Coloplast A/S: Erectile Dysfunction; Penile implant; Titan
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

Participant Flow

Arm/Group Title	Titan® OTR IPP
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

Baseline Characteristics

Arm/Group Title	Titan® OTR IPP
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 Participants	124
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	76 61.3%
>=65 years	48 38.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.0 (9.1)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	124 100%
Region of Enrollment (participants) [Number]
United States	71 57.3%
Canada	27 21.8%
United Kingdom	26 21%

Outcome Measures

1. Primary Outcome

Title	Assess the Ease of Deflation of the Titan® OTR Pump
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% of participants meeting success criter]	70.8 57.1%

2. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 1
Description	Subject Satisfaction - overall function
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	72.4

3. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 1
Description	Subject Satisfaction - overall function
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% satisfactory or somewhat satisfactory]	90.6

4. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 1
Description	Subject Satisfaction - overall function
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	90
Number [% satisfactory or somewhat satisfactory]	90.0

5. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 2
Description	Subject Satisfaction - soft enough to conceal when deflated
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	62.8

6. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 2
Description	Subject Satisfaction - soft enough to conceal when deflated
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% satisfactory or somewhat satisfactory]	76.0

7. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 2
Description	Subject Satisfaction - soft enough to conceal when deflated
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	90
Number [% satisfactory or somewhat satisfactory]	82.2

8. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 3
Description	Subject Satisfaction - ease of locating the deflation touch pads
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	60.6

9. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 3
Description	Subject Satisfaction - ease of locating the deflation touch pads
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% satisfactory or somewhat satisfactory]	78.2

10. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 3
Description	Subject Satisfaction - ease of locating the deflation touch pads
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	89
Number [% satisfactory or somewhat satisfactory]	77.6

11. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 4
Description	Subject Satisfaction - ease of inflation
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	68.1

12. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 4
Description	Subject Satisfaction - ease of inflation
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	95
Number [% satisfactory or somewhat satisfactory]	85.3

13. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 4
Description	Subject Satisfaction - ease of inflation
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	88
Number [% satisfactory or somewhat satisfactory]	86.4

14. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 5
Description	Subject Satisfaction - ease of deflation
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	60.6

15. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 5
Description	Subject Satisfaction - ease of deflation
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% satisfactory or somewhat satisfactory]	70.8

16. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 5
Description	Subject Satisfaction - ease of deflation
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	90
Number [% satisfactory or somewhat satisfactory]	73.3

17. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 6
Description	Subject Satisfaction - hardness of erection when inflated
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	82.0

18. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 6
Description	Subject Satisfaction - hardness of erection when inflated
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	91.5

19. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 6
Description	Subject Satisfaction - hardness of erection when inflated
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	89
Number [% satisfactory or somewhat satisfactory]	93.2

20. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 7
Description	Subject Satisfaction - width when inflated
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	77.6

21. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 7
Description	Subject Satisfaction - width when inflated
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	86.1

22. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 7
Description	Subject Satisfaction - width when inflated
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	89
Number [% satisfactory or somewhat satisfactory]	79.8

23. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 8
Description	Subject Satisfaction - length when inflated
Time Frame	3 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% satisfactory or somewhat satisfactory]	54.3

24. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 8
Description	Subject Satisfaction - length when inflated
Time Frame	6 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	95
Number [% satisfactory or somewhat satisfactory]	61.1

25. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 8
Description	Subject Satisfaction - length when inflated
Time Frame	12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	90
Number [% satisfactory or somewhat satisfactory]	68.9

26. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 9
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% responding "yes" and "probably"]	79.8

27. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 9
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% responding "yes" and "probably"]	86.5

28. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 9
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	90
Number [% responding "yes" and "probably"]	87.8

29. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 10
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	94
Number [% responding "yes" and "probably"]	72.4

30. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 10
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	96
Number [% responding "yes" and "probably"]	83.3

31. Secondary Outcome

Title	Evaluate User Acceptance of Titan® OTR - Question 10
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	90
Number [% responding "yes" and "probably"]	86.7

32. Secondary Outcome

Title	Assess the Ease of Implant of the Titan® OTR Question 1
Description	Titan OTR pre-implant product preparation was straightforward/simple?
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	113
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
Description	Titan OTR pre-implant product preparation was easier than your usual pump of choice?
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	113
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
Description	The subject was easily able to accommodate the OTR pump?
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	113
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
Description	It was easy for the subject to find the inflation bulb?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	0.0 0%
A little	0.9 0.7%
Somewhat	4.6 3.7%
Very	13.9 11.2%
Extremely	80.6 65%

36. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 2
Description	It was easy for the subject to find the deflation touch pads?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	1.9 1.5%
A little	3.7 3%
Somewhat	9.3 7.5%
Very	26.9 21.7%
Extremely	58.3 47%

37. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 3
Description	It was easy for the subject to inflate the device?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	1.9 1.5%
A little	0.9 0.7%
Somewhat	4.6 3.7%
Very	17.6 14.2%
Extremely	75.0 60.5%

38. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 4
Description	It was easy for the subject to compress the deflation touch pads?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	2.8 2.3%
A little	1.9 1.5%
Somewhat	10.2 8.2%
Very	25.9 20.9%
Extremely	59.3 47.8%

39. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 5
Description	Subject training with OTR pump was easier than with previous pump?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	1.9 1.5%
A little	1.9 1.5%
Somewhat	16.7 13.5%
Very	16.7 13.5%
Extremely	63.0 50.8%

40. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 6
Description	The OTR pump was easy to use at 1st cycling?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	1.9 1.5%
A little	5.6 4.5%
Somewhat	8.3 6.7%
Very	21.3 17.2%
Extremely	63.0 50.8%

41. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 7
Description	The subject likes the OTR pump?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	108
Not at all	0.9 0.7%
A little	3.7 3%
Somewhat	13.0 10.5%
Very	20.4 16.5%
Extremely	62.0 50%

42. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 8
Description	How easy was it for the subject to learn?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	107
Not at all	2.8 2.3%
A little	8.4 6.8%
Somewhat	7.5 6%
Very	29.9 24.1%
Extremely	51.4 41.5%

43. Secondary Outcome

Title	Assess the Ease of Training for Titan® OTR - Question 9
Description	How likely the subject will need continued training or retraining?
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	107
Not at all	5.6 4.5%
A little	10.3 8.3%
Somewhat	11.2 9%
Very	25.2 20.3%
Extremely	47.7 38.5%

44. Secondary Outcome

Title	Assess Partner Satisfaction (Where Applicable)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	59
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Titan® OTR IPP
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.
Measure Participants	39
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)

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Titan® OTR IPP
	Affected / at Risk (%)	# Events
Total	10/113 (8.8%)
Surgical and medical procedures
Infection	4/113 (3.5%)	4
Hematoma	2/113 (1.8%)	2
Device malfunction	2/113 (1.8%)	2
Chronic pain	1/113 (0.9%)	1
Cylinder extrusion	1/113 (0.9%)	1
Scrotal abscess	1/113 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Titan® OTR IPP
	Affected / at Risk (%)	# Events
Total	14/113 (12.4%)
Surgical and medical procedures
Auto inflation	14/113 (12.4%)	14

Limitations/Caveats

[Not Specified]

More Information

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.