Erectile DysfunctionNCT00731666

Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)

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

Completed

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

Official record

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Trial summary

This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation. Read more about this study

Who is it for?: Ages 25 to 75 years, 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: 40 participants
Where: 3 sitesUnited States
Study dates: Dec 2007to May 2011
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 25 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Has an estimated life expectancy of more than 5 years
Has been diagnosed with erectile dysfunction
Is willing to have the Titan IPP implanted
Is able and willing to complete all follow-up visits and procedures indicated in this protocol
Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site

Who cannot join

Participant has had a previous penile prosthesis or prior penile enlargement surgeries
Participant has a compromised immune system
Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
Participant does not have manual dexterity or mental ability to operate the pump
Participant has an active urogenital infection or active skin infection in region of surgery
Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease

Show all 9Show fewer

Participant is diagnosed with Chordee
Participant has neuropathy
Participant has a serious bleeding disorder or coagulopathy

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Texas Health Science Center at Houston
Houston, Texas, 77030
Regional Urology, LLC
Shreveport, Louisiana, 71106
James A Haley VA
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation

Conditions: Erectile Dysfunction
Being tested: Inflatable Penile Prosthesis
Keywords: penile length, IPP, Erectile dysfunction
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
Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.

Study groups in NCT00731666
Study group	Role	What they receive
Titan® IPP	Other	Subjects implanted with Titan® IPP Receives: Device: Inflatable Penile Prosthesis

What is being measured

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

The Study's Primary Objective Will Assess the Change in Penile Length.
Measured: 12 months

Secondary outcomes (2)

Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.
Measured: 12 and 24 months
The Rate of Change in Male Stress Urinary Incontinence(SUI).
Subject responses to 3 questions were evaluated:
1. On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?
2. Overall, how often have you needed to change your daily activities because of urinary incontinence?
3. Overall, how big of a social problem has urinary incontinence been for you during the past month?
Measured: 12 months

Timeline

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

Dec 2007May 2011

First posted11 Aug 2008 (estimated)
Study startDec 2007
Primary completionMay 2010
Study completionMay 2011

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00731666
Sponsor's protocol ID: US001SU
Status last verified: Sep 2013
First submitted: 7 Aug 2008
Last updated: 28 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Henry GD, Carrion R, Jennermann C, Wang R. Prospective evaluation of postoperative penile rehabilitation: penile length/girth maintenance 1 year following Coloplast Titan inflatable penile prosthesis. J Sex Med. 2015 May;12(5):1298-304. doi: 10.1111/jsm.12833. Epub 2015 Apr 14.
PubMed 25872574

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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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation
ClinicalTrials.gov ID: NCT00731666
Acronym / sponsor ID: US001SU
Conditions: Erectile Dysfunction
Keywords: penile length, IPP, Erectile dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: May 2010 (actual)
Study completion: May 2011 (actual)
First posted: 11 Aug 2008 (estimated)
Results: Posted 28 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

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

Arm	Type	Receives
Titan® IPP	Other	Device: Inflatable Penile ProsthesisSubjects implanted with Titan® IPP

Who may qualify

Ages: 25 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Has an estimated life expectancy of more than 5 years
Has been diagnosed with erectile dysfunction
Is willing to have the Titan IPP implanted
Is able and willing to complete all follow-up visits and procedures indicated in this protocol
Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site

Key exclusion criteria (9 listed)

Participant has had a previous penile prosthesis or prior penile enlargement surgeries
Participant has a compromised immune system
Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
Participant does not have manual dexterity or mental ability to operate the pump
Participant has an active urogenital infection or active skin infection in region of surgery

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: TitanHydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction. The implant provides the participant with voluntary control over the erect and flaccid states of the penis.	Device	Titan® IPP

Primary outcome

The Study's Primary Objective Will Assess the Change in Penile Length.
Time frame: 12 months

2 secondary outcomes

Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.
Time frame: 12 and 24 months
The Rate of Change in Male Stress Urinary Incontinence(SUI).
Time frame: 12 months

Results and safety

Results posted to the registry on 28 Nov 2013, 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® IPP	40	28

Primary outcome: The Study's Primary Objective Will Assess the Change in Penile Length.

Time frame: 12 months. Mean (Standard Deviation). Unit: cm

Measure	Titan® IPP n = 31
Pubic bone to meatus - erect	1.14 (1.94)
Pubic bone to meatus - flaccid	0.99 (1.64)
Pubic bone to meatus - stretched	1.04 (1.94)
Pubic bone to proximal end of corona - erect	0.94 (1.41)
Pubic bone to proximal end of corona - flaccid	0.69 (1.69)
Pubic bone to proximal end of corona - stretched	0.59 (1.59)
Pubopenile skin junction to meatus - erect	0.93 (1.41)
Pubopenile skin junction to meatus - flaccid	0.71 (1.48)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for 24 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Titan® IPP	1 of 40 (2.5%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25872574Henry GD, Carrion R, Jennermann C, Wang R. Prospective evaluation of postoperative penile rehabilitation: penile length/girth maintenance 1 year following Coloplast Titan inflatable penile prosthesis. J Sex Med. 2015 May;12(5):1298-304. doi: 10.1111/jsm.12833. Epub 2015 Apr 14.

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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.

Gerard Henry, MD principal investigator

Regional Urology, LLC

Rafael Carrion, MD principal investigator

JAames A Haley VA

Run Wang, MD principal investigator

University of Texas

3 sites in 1 country: 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 3 sites in United States.

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 5 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 28 Nov 2013). 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?

The Study's Primary Objective Will Assess the Change in Penile Length. (time frame: 12 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 NCT00731666, 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 28 Nov 2013.