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

NCT ID: NCT01378559

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

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.

Detailed Description

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Conditions

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Erectile Dysfunction Intraoperative Complications Postoperative Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Penis prosthesis cohort

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire

Intervention Type OTHER

A questionnaire accessing satisfaction with a penis prosthesis

Interventions

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Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire

A questionnaire accessing satisfaction with a penis prosthesis

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Sønksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital, University of Copenhagen

Locations

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Department of urology, Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Titan-2011

Identifier Type: -

Identifier Source: org_study_id

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