N/A
Completed N=124
Titan® One Touch Release Inflatable Penile Prosthesis
Source: ClinicalTrials.gov NCT00731939 ↗Enrolled (actual)
124
Serious AEs
8.9%
Results posted
Apr 2014
Primary outcomePrimary: Assess the Ease of Deflation of the Titan® OTR Pump — 70.8 % of participants meeting success criter
Summary
The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Ease of Deflation of the Titan® OTR Pump |
70.8 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 1 |
90.0 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 2 |
82.2 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 3 |
77.6 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 4 |
86.4 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 5 |
73.3 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 6 |
93.2 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 7 |
79.8 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 8 |
68.9 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 9 |
87.8 | — |
| SECONDARY Evaluate User Acceptance of Titan® OTR - Question 10 |
86.7 | — |
| SECONDARY Assess the Ease of Implant of the Titan® OTR Question 1 |
0.0; 0.0; 2.7; 22.1; 75.2 | — |
| SECONDARY Assess the Ease of Implant of the Titan® OTR - Question 2 |
0.0; 0.0; 10.6; 40.7; 48.7 | — |
| SECONDARY Assess the Ease of Implant of the Titan® OTR - Question 3 |
0.0; 0.0; 2.7; 20.4; 77.0 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 1 |
0.0; 0.9; 4.6; 13.9; 80.6 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 2 |
1.9; 3.7; 9.3; 26.9; 58.3 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 3 |
1.9; 0.9; 4.6; 17.6; 75.0 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 4 |
2.8; 1.9; 10.2; 25.9; 59.3 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 5 |
1.9; 1.9; 16.7; 16.7; 63.0 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 6 |
1.9; 5.6; 8.3; 21.3; 63.0 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 7 |
0.9; 3.7; 13.0; 20.4; 62.0 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 8 |
2.8; 8.4; 7.5; 29.9; 51.4 | — |
| SECONDARY Assess the Ease of Training for Titan® OTR - Question 9 |
5.6; 10.3; 11.2; 25.2; 47.7 | — |
| SECONDARY Assess Partner Satisfaction (Where Applicable) |
67.8; 74.8; 64.7; 62.2; 71.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00731939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.