Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
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ClinicalTrials.gov Identifier: NCT00731666 |
Recruitment Status
:
Completed
First Posted
: August 11, 2008
Results First Posted
: November 28, 2013
Last Update Posted
: November 28, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Dysfunction | Device: Inflatable Penile Prosthesis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Titan® IPP
Subjects implanted with Titan® IPP
|
Device: Inflatable Penile Prosthesis
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.
Other Name: Titan
|
- The Study's Primary Objective Will Assess the Change in Penile Length. [ Time Frame: 12 months ]
- 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 ]
Subject responses to 3 questions were evaluated:
- On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?
- Overall, how often have you needed to change your daily activities because of urinary incontinence?
- Overall, how big of a social problem has urinary incontinence been for you during the past month?

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Ages Eligible for Study: | 25 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Participant is diagnosed with Chordee
- Participant has neuropathy
- Participant has a serious bleeding disorder or coagulopathy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731666
United States, Florida | |
James A Haley VA | |
Tampa, Florida, United States, 33612 | |
United States, Louisiana | |
Regional Urology, LLC | |
Shreveport, Louisiana, United States, 71106 | |
United States, Texas | |
University of Texas Health Science Center at Houston | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Gerard Henry, MD | Regional Urology, LLC | |
Principal Investigator: | Rafael Carrion, MD | JAames A Haley VA | |
Principal Investigator: | Run Wang, MD | University of Texas |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Coloplast A/S |
ClinicalTrials.gov Identifier: | NCT00731666 History of Changes |
Other Study ID Numbers: |
US001SU |
First Posted: | August 11, 2008 Key Record Dates |
Results First Posted: | November 28, 2013 |
Last Update Posted: | November 28, 2013 |
Last Verified: | September 2013 |
Keywords provided by Coloplast A/S:
penile length IPP Erectile dysfunction |
Additional relevant MeSH terms:
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Mental Disorders |