Status:
COMPLETED
Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
Lead Sponsor:
The Cleveland Clinic
Conditions:
Prostate Cancer
Post-Brachytherapy Bladder Outlet Obstruction
Eligibility:
MALE
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the feasibility, safety, and efficacy of the Memokath® 028SW stent to prevent urinary obstructive symptoms (difficulty urinating) when used after prostate see...
Detailed Description
Image-guided transperineal permanent prostate brachytherapy (PI) is an accepted curative treatment option for patients with early stage prostate cancer. Multiple reports have defined its efficacy and ...
Eligibility Criteria
Inclusion
- eligible for prostate seed implant
- 50 years of age or older
- able to give informed consent
Exclusion
- presence of any other urologic implant, including stents,penile prosthesis or artificial sphincter
- history of transurethral resection of prostate (TURP)procedure
- presence of urethral diverticuli
- presence of urethral strictures
- presence of bladder calculi or tumors
- prostatic urethra is less than 2.5 cm or greater than 6.5 cm
- inability to participate in study activities due to physical or mental limitations
- inability or unwillingness to return for all the required follow-up visits
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00252941
Start Date
November 1 2005
End Date
November 1 2006
Last Update
December 21 2010
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195