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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
James A Haley VA
Tampa, Florida, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
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).
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?
Time frame: 12 months
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