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

Completed

• Conditions: Erectile Dysfunction; Intraoperative Complications; Postoperative Complications
• Interventions: Other: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire

• Registration Number: NCT01378559
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.

Exclusion Criteria

• Inability to read Danish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Penis prosthesis cohort	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Patient satisfaction assessed by EDITS question 1	Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months	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

Secondary Outcome Measures

Name	Time	Method
Complications	At the beginning of study when the chart review is conducted	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.
Patient satisfaction assessed by EDITS questions 2-13	Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months	"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

Trial Locations

Locations (1)

Department of urology, Herlev Hospital; 🇩🇰 Herlev, Denmark