Erectile DysfunctionNCT01378559
Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis
An observational study of Erectile Dysfunction and Intraoperative Complications, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Intraoperative Complications, Postoperative Complications
- What is being tested?
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital / Frederikssund Hospital.
Who may be able to join
- Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.
Who cannot join
- Inability to read Danish
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire
- Keywords
- Penis prosthesis, Titan, Satisfaction, Complications
- Medical subject headings
- Erectile Dysfunction, Intraoperative Complications, Postoperative Complications, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) QuestionnaireOther
A questionnaire accessing satisfaction with a penis prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Penis prosthesis cohort | Not described Receives: Other: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction assessed by EDITS question 1
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
Measured: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months
Secondary outcomes (2)
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.
Measured: At the beginning of study when the chart review is conducted
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
Measured: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Sønksen, MD, PhD, Principal investigator, Herlev Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378559
- Sponsor's protocol ID
- Titan-2011
- Status last verified
- Feb 2012
- First submitted
- 15 Jun 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Complications With the New Titan® One Touch Release (OTR) Penis Prosthesis
- ClinicalTrials.gov ID
- NCT01378559
- Acronym / sponsor ID
- Titan-2011
- Keywords
- Penis prosthesis, Titan, Satisfaction, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penis prosthesis cohort | – | Other: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital / Frederikssund Hospital.
Key inclusion criteria (1 listed)
- Men who have had a Titan one touch release penis prosthesis implanted at Herlev Hospital.
Key exclusion criteria (1 listed)
- Inability to read Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) QuestionnaireA questionnaire accessing satisfaction with a penis prosthesis | Other | Penis prosthesis cohort |
Primary outcome
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: 1. Overall how satisfied are you with penile prosthesis? Very satisfied Somewhat satisfied Neither satisfied or dissatisfied Somewhat dissatisfied Very dissatisfied
2 secondary outcomes
Complications
Time frame: At the beginning of study when the chart review is conducted
Patient satisfaction assessed by EDITS questions 2-13
Time frame: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Sønksen, MD, PhD principal investigator
Herlev Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Intraoperative Complications, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction assessed by EDITS question 1 (time frame: Satisfaction will be assessed when questionnaires are returned - expected avarage 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.