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

NCT01378559 | Completed

• 1 other identifier: Titan-2011
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Intraoperative Complications; Postoperative Complications

Keywords

Penis prosthesis; Titan; Satisfaction; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complications

  At the beginning of study when the chart review is conducted

• Patient satisfaction assessed by EDITS questions 2-13

  Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months

Study Arms (1)

Penis prosthesis cohort

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

Interventions

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire OTHER

A questionnaire accessing satisfaction with a penis prosthesis

Penis prosthesis cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Inability to read Danish

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Department of urology, Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Erectile Dysfunction; Intraoperative Complications; Postoperative Complications; Personal Satisfaction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jens Sønksen, MD, PhD

  Herlev Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

DK (1)