Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)

Study Overview
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Brief Summary
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This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.

Official Title
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Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation

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: Has an estimated life expectancy of more than 5 years Has been diagnosed with erectile dysfunction Is willing to have the Titan IPP implanted Is able and willing to complete all follow-up visits and procedures indicated in this protocol Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site Exclusion Criteria: Participant has had a previous penile prosthesis or prior penile enlargement surgeries Participant has a compromised immune system Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment Participant does not have manual dexterity or mental ability to operate the pump Participant has an active urogenital infection or active skin infection in region of surgery Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease Participant is diagnosed with Chordee Participant has neuropathy Participant has a serious bleeding disorder or coagulopathy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 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® IPP<br>Subjects implanted with Titan® IPP | Device: Inflatable Penile Prosthesis<br>* Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.<br>* Other names: Titan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Study's Primary Objective Will Assess the Change in Penile Length. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. |  | 12 and 24 months | 
| The Rate of Change in Male Stress Urinary Incontinence(SUI). | Subject responses to 3 questions were evaluated: On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day? Overall, how often have you needed to change your daily activities because of urinary incontinence? Overall, how big of a social problem has urinary incontinence been for you during the past month? | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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penile length, IPP, Erectile dysfunction