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

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.

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Key information

Conditions

Erectile Dysfunction Behavior Genital Diseases Genital Diseases, Male Intraoperative Complications Male Urogenital Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Postoperative Complications Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Department of urology, Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Inability to read Danish

Treatment and study plan

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire

Other

A questionnaire accessing satisfaction with a penis prosthesis

Primary outcomes

Patient satisfaction assessed by EDITS question 1

Time frame: 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:
- Overall how satisfied are you with penile prosthesis? Very satisfied Somewhat satisfied Neither satisfied or dissatisfied Somewhat dissatisfied Very dissatisfied

Secondary outcomes

Complications

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 22, 2011
Registry last updated: Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed