Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
Completed · Not applicable
Conditions studied: Erectile Dysfunction
In brief
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.
Key facts
- Study ID
- NCT00731666
- Run by
- Coloplast A/S
- People needed
- 40
- Starts
- 2007-12-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-11-28
Who can join
Age: 25 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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