Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis

Study Overview
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Brief Summary
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The purpose of this study is to assess patient satisfaction with the Titan one touch release penis prosthesis and to register complications with this prosthesis. This will regard the first prostheses inserted at Herlev Hospital/Frederikssund Hospital. Patient satisfaction will be assessed by mailing out the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire and recording the patient answers. The most important question will be Overall how satisfied are you with penile prosthesis?. Complications (including infection, bleeding, and mechanical failure) will be assessed by a patient chart review and confirmed by a brief phone interview.

Official Title
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Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis

Conditions
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Erectile Dysfunction, Intraoperative Complications, Postoperative Complications

Intervention / Treatment
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* Other: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital. Exclusion Criteria: Inability to read Danish

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Penis prosthesis cohort<br> | Other: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire<br>* A questionnaire accessing satisfaction with a penis prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction assessed by EDITS question 1 | Patient satisfaction assesed by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire, Question 1: 1. Overall how satisfied are you with penile prosthesis? Very satisfied Somewhat satisfied Neither satisfied or dissatisfied Somewhat dissatisfied Very dissatisfied | Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications may include: Bleeding, Infection, Mechanical problems with the device, Erosion, Pain, Penile shortening, Auto inflation, Other complications. The number and nature of all complications will be noted. Complications are assessed by patient chart review and a brief phone interview with the patient. | At the beginning of study when the chart review is conducted | 
| Patient satisfaction assessed by EDITS questions 2-13 | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire questions 2-13 include questions about: Expectations Continued use of device Ease and frequency of use Confidence Partner satisfaction Erectile function Future surgery Recommendations for others | Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penis prosthesis, Titan, Satisfaction, Complications