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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01378559
Enrollment
26
Registered
2011-06-22
Start date
2011-06-30
Completion date
2012-02-29
Last updated
2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Intraoperative Complications, Postoperative Complications

Keywords

Penis prosthesis, Titan, Satisfaction, Complications

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.

Interventions

OTHERErectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire

A questionnaire accessing satisfaction with a penis prosthesis

Sponsors

Copenhagen University Hospital at Herlev
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Inability to read Danish

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction assessed by EDITS question 1Satisfaction will be assessed when questionnaires are returned - expected avarage 2 monthsPatient 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

MeasureTime frameDescription
ComplicationsAt the beginning of study when the chart review is conductedComplications 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 2-13Satisfaction will be assessed when questionnaires are returned - expected avarage 2 monthsErectile 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026