Titan® One Touch Release Inflatable Penile Prosthesis

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

Official Title
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Titan® One Touch Release Inflatable Penile Prosthesis

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Inflatable Penile Prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Titan® OTR IPP<br>Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP) | Device: Inflatable Penile Prosthesis<br>* Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.<br>* Other names: Titan® OTR;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate User Acceptance of Titan® OTR - Question 1 | Subject Satisfaction - overall function | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 1 | Subject Satisfaction - overall function | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 1 | Subject Satisfaction - overall function | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 2 | Subject Satisfaction - soft enough to conceal when deflated | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 2 | Subject Satisfaction - soft enough to conceal when deflated | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 2 | Subject Satisfaction - soft enough to conceal when deflated | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 3 | Subject Satisfaction - ease of locating the deflation touch pads | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 3 | Subject Satisfaction - ease of locating the deflation touch pads | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 3 | Subject Satisfaction - ease of locating the deflation touch pads | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 4 | Subject Satisfaction - ease of inflation | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 4 | Subject Satisfaction - ease of inflation | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 4 | Subject Satisfaction - ease of inflation | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 5 | Subject Satisfaction - ease of deflation | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 5 | Subject Satisfaction - ease of deflation | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 5 | Subject Satisfaction - ease of deflation | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 6 | Subject Satisfaction - hardness of erection when inflated | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 6 | Subject Satisfaction - hardness of erection when inflated | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 6 | Subject Satisfaction - hardness of erection when inflated | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 7 | Subject Satisfaction - width when inflated | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 7 | Subject Satisfaction - width when inflated | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 7 | Subject Satisfaction - width when inflated | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 8 | Subject Satisfaction - length when inflated | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 8 | Subject Satisfaction - length when inflated | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 8 | Subject Satisfaction - length when inflated | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 9 | Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had? | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 9 | Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had? | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 9 | Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had? | 12 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 10 | Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again? | 3 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 10 | Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again? | 6 months post-surgery | 
| Evaluate User Acceptance of Titan® OTR - Question 10 | Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again? | 12 months post-surgery | 
| Assess the Ease of Implant of the Titan® OTR Question 1 | Titan OTR pre-implant product preparation was straightforward/simple? | At implant | 
| Assess the Ease of Implant of the Titan® OTR - Question 2 | Titan OTR pre-implant product preparation was easier than your usual pump of choice? | At implant | 
| Assess the Ease of Implant of the Titan® OTR - Question 3 | The subject was easily able to accommodate the OTR pump? | At implant | 
| Assess the Ease of Training for Titan® OTR - Question 1 | It was easy for the subject to find the inflation bulb? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 2 | It was easy for the subject to find the deflation touch pads? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 3 | It was easy for the subject to inflate the device? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 4 | It was easy for the subject to compress the deflation touch pads? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 5 | Subject training with OTR pump was easier than with previous pump? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 6 | The OTR pump was easy to use at 1st cycling? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 7 | The subject likes the OTR pump? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 8 | How easy was it for the subject to learn? | 6 weeks | 
| Assess the Ease of Training for Titan® OTR - Question 9 | How likely the subject will need continued training or retraining? | 6 weeks | 
| Assess Partner Satisfaction (Where Applicable) | The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline. | Baseline | 
| Assess Partner Satisfaction (Where Applicable) | The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Penile implant, Titan