Erectile DysfunctionNCT00731939

Titan® One Touch Release Inflatable Penile Prosthesis

A study testing Inflatable Penile Prosthesis in people with Erectile Dysfunction, run by Coloplast A/S at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Erectile Dysfunction
What is being tested?: Inflatable Penile Prosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 8 sitesin 3 countries
Study dates: Nov 2007to Apr 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Participant has an estimated life expectancy of more than 5 years
Participant has been diagnosed with erectile dysfunction (impotence)
participant is willing to have the Titan OTR IPP implanted
Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol

Who cannot join

Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
Participant had a previous penile prosthesis or prior penile enlargement surgeries
Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability
Participant does not have the manual dexterity or mental ability to operate the pump

Show all 9Show fewer

Participant has chordee or priapism
Participant has penile sensory neuropathy
Participant has serious bleeding disorder

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

United States6 sites

Emory Healthcare
Altanta, Georgia, 30322
Michigan Urology Center
Ann Arbor, Michigan, 48109
Boston Medical Center
Boston, Massachusetts, 02118
Rush Presbyterian
Chicago, Illinois, 60612
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology San Antonio
San Antonio, Texas, 78229

Other trials in United States

Canada1 site

St Joseph's Hospital
London, Ontario, N6A 4V2

Other trials in Canada

United Kingdom1 site

University College London Hospital
London, UK, W1G 6BJ

Other trials in United Kingdom

About this study

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.

Conditions: Erectile Dysfunction
Being tested: Inflatable Penile Prosthesis
Keywords: Erectile Dysfunction, Penile implant, Titan
Medical subject headings: Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inflatable Penile ProsthesisDevice
Also called Titan®, Titan® OTR
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.

Study groups in NCT00731939
Study group	Role	What they receive
Titan® OTR IPP	Other	Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP) Receives: Device: Inflatable Penile Prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess the Ease of Deflation of the Titan® OTR Pump
The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of "satisfactory" or "somewhat satisfactory". Other possible responses were "neither satisfactory nor unsatisfactory", "somewhat unsatisfactory", and "very unsatisfactory".
Measured: 6 months

Secondary outcomes (44)

Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1
Subject Satisfaction - overall function
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Subject Satisfaction - soft enough to conceal when deflated
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Subject Satisfaction - ease of locating the deflation touch pads
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Subject Satisfaction - ease of inflation
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Subject Satisfaction - ease of deflation
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Subject Satisfaction - hardness of erection when inflated
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Subject Satisfaction - width when inflated
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Subject Satisfaction - length when inflated
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9
Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9
Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9
Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?
Measured: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10
Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Measured: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10
Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Measured: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10
Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?
Measured: 12 months post-surgery
Assess the Ease of Implant of the Titan® OTR Question 1
Titan OTR pre-implant product preparation was straightforward/simple?
Measured: At implant
Assess the Ease of Implant of the Titan® OTR - Question 2
Titan OTR pre-implant product preparation was easier than your usual pump of choice?
Measured: At implant
Assess the Ease of Implant of the Titan® OTR - Question 3
The subject was easily able to accommodate the OTR pump?
Measured: At implant
Assess the Ease of Training for Titan® OTR - Question 1
It was easy for the subject to find the inflation bulb?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 2
It was easy for the subject to find the deflation touch pads?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 3
It was easy for the subject to inflate the device?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 4
It was easy for the subject to compress the deflation touch pads?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 5
Subject training with OTR pump was easier than with previous pump?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 6
The OTR pump was easy to use at 1st cycling?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 7
The subject likes the OTR pump?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 8
How easy was it for the subject to learn?
Measured: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 9
How likely the subject will need continued training or retraining?
Measured: 6 weeks
Assess Partner Satisfaction (Where Applicable)
The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.
Measured: Baseline
Assess Partner Satisfaction (Where Applicable)
The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Apr 2010

First posted11 Aug 2008 (estimated)
Study startNov 2007
Primary completionOct 2009
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00731939
Sponsor's protocol ID: DK057CC
Status last verified: Mar 2014
First submitted: 7 Aug 2008
Last updated: 14 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ohl DA, Brock G, Ralph D, Bogache W, Jones L, Munarriz R, Levine L, Ritenour C. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast titan one touch release three-piece inflatable penile prosthesis. J Sex Med. 2012 Sep;9(9):2467-74. doi: 10.1111/j.1743-6109.2012.02819.x. Epub 2012 Jul 3.
PubMed 22759540

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Titan® One Touch Release Inflatable Penile Prosthesis
ClinicalTrials.gov ID: NCT00731939
Acronym / sponsor ID: DK057CC
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction, Penile implant, Titan
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Oct 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 14 Apr 2014

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 the ease of deflation of the Titan® OTR pump.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Titan® OTR IPP	Other	Device: Inflatable Penile ProsthesisSubjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participant has an estimated life expectancy of more than 5 years
Participant has been diagnosed with erectile dysfunction (impotence)
participant is willing to have the Titan OTR IPP implanted
Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol

Key exclusion criteria (9 listed)

Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
Participant had a previous penile prosthesis or prior penile enlargement surgeries
Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability

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
Inflatable Penile ProsthesisAlso: Titan®, Titan® OTRHydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction.	Device	Titan® OTR IPP

Primary outcome

Assess the Ease of Deflation of the Titan® OTR Pump
Time frame: 6 months
The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of "satisfactory" or "somewhat satisfactory". Other possible responses were "neither satisfactory nor unsatisfactory", "somewhat unsatisfactory", and "very unsatisfactory".

44 secondary outcomes

Evaluate User Acceptance of Titan® OTR - Question 1
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 1
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 2
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 3
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 4
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 5
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 6
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 7
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 8
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 9
Time frame: 12 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10
Time frame: 3 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10
Time frame: 6 months post-surgery
Evaluate User Acceptance of Titan® OTR - Question 10
Time frame: 12 months post-surgery
Assess the Ease of Implant of the Titan® OTR Question 1
Time frame: At implant
Assess the Ease of Implant of the Titan® OTR - Question 2
Time frame: At implant
Assess the Ease of Implant of the Titan® OTR - Question 3
Time frame: At implant
Assess the Ease of Training for Titan® OTR - Question 1
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 2
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 3
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 4
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 5
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 6
Time frame: 6 weeks
Assess the Ease of Training for Titan® OTR - Question 7
Time frame: 6 weeks

Results and safety

Results posted to the registry on 14 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Titan® OTR IPP	124	90

Primary outcome: Assess the Ease of Deflation of the Titan® OTR Pump

Time frame: 6 months. Number. Unit: % of participants meeting success criter

Measure	Titan® OTR IPP n = 96
Value	70.8

44 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Titan® OTR IPP	10 of 113 (8.8%)	14 of 113 (12.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22759540Ohl DA, Brock G, Ralph D, Bogache W, Jones L, Munarriz R, Levine L, Ritenour C. Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast titan one touch release three-piece inflatable penile prosthesis. J Sex Med. 2012 Sep;9(9):2467-74. doi: 10.1111/j.1743-6109.2012.02819.x. Epub 2012 Jul 3.

Related trials for Erectile Dysfunction

RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
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RecruitingPhase 2
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Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
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Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
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Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
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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.

Gerald Brock, MD principal investigator

St Joseph's Hospital

Ricardo Munarriz, MD principal investigator

Boston Medical Center

Lawrence Levine, MD principal investigator

Rush Presbyterian

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Inflatable Penile Prosthesis in people with Erectile Dysfunction, run by Coloplast A/S at 8 sites in 3 countries.

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 4 inclusion and 9 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 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada, United Kingdom. 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?

Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assess the Ease of Deflation of the Titan® OTR Pump (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731939, which also lists 1 linked publication.

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 14 Apr 2014.