IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
This study has been completed.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00731666
First received: August 7, 2008
Last updated: September 27, 2013
Last verified: September 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Erectile Dysfunction | Device: Inflatable Penile Prosthesis |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Coloplast A/S:
Primary Outcome Measures:
- The Study's Primary Objective Will Assess the Change in Penile Length. [ Time Frame: 12 months ]
Secondary Outcome Measures:
- 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?
| Enrollment: | 40 |
| Study Start Date: | December 2007 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731666
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731666
Locations
| 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 | |
Sponsors and Collaborators
Coloplast A/S
Investigators
| 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 |
More Information
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 |
| Study First Received: | August 7, 2008 |
| Results First Received: | September 27, 2013 |
| Last Updated: | September 27, 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 |
ClinicalTrials.gov processed this record on June 23, 2017