Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
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.
|Study Design:||Endpoint Classification: Efficacy Study
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|
- The Study's Primary Objective Will Assess the Change in Penile Length. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- The Rate of Change in Male Stress Urinary Incontinence(SUI). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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?
|Study Start Date:||December 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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
|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|