Status:
COMPLETED
Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
Lead Sponsor:
Coloplast A/S
Conditions:
Erectile Dysfunction
Eligibility:
MALE
25-75 years
Phase:
NA
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 incor...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00731666
Start Date
December 1 2007
End Date
May 1 2011
Last Update
November 28 2013
Active Locations (3)
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1
James A Haley VA
Tampa, Florida, United States, 33612
2
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
3
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030