Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
|ClinicalTrials.gov Identifier: NCT00731666|
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
|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)|
|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|
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?
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|