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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378559
• Other study ID #: Titan-2011
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: February 21, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Intraoperative Complications
• Postoperative Complications

Intervention

Other:
• Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire
A questionnaire accessing satisfaction with a penis prosthesis

Locations

Country	Name	City	State
Denmark	Department of urology, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No