Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
- Conditions
- Erectile Dysfunction
- Interventions
- Device: Inflatable Penile Prosthesis
- Registration Number
- NCT00731666
- Lead Sponsor
- Coloplast A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Titan® IPP Inflatable Penile Prosthesis Subjects implanted with Titan® IPP
- Primary Outcome Measures
Name Time Method The Study's Primary Objective Will Assess the Change in Penile Length. 12 months
- Secondary Outcome Measures
Name Time Method Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire. 12 and 24 months The Rate of Change in Male Stress Urinary Incontinence(SUI). 12 months 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?
Trial Locations
- Locations (3)
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