Status:
COMPLETED
A Study of Intra-operative Autologous Retropubic Urethral Sling on Urinary Control After Robot Assisted Radical Prostatectomy
Lead Sponsor:
University of California, San Francisco
Conditions:
Men With Prostate Cancer Undergoing Robot Assisted Radical Prostatectomy
Eligibility:
MALE
45-75 years
Phase:
NA
Brief Summary
Placement of an autologous retropubic urethral sling at the time of robot assisted radical prostatectomy will improve the recovery of continence after radical prostatectomy
Detailed Description
This is a phase 2 single blinded study of patients undergoing robot assisted radical prostatectomy who are randomized to placement of an autologous retropubic urethral sling or not. Placement of a ret...
Eligibility Criteria
Inclusion
- Newly diagnosed patients undergoing robot assisted radical prostatectomy at UCSF
- Histologically defined adenocarcinoma of the prostate
- English or Spanish speaking patients with the ability to provide informed written consent and willingness to comply with the requirements of the protocol
- Age 40-75 year
Exclusion
- · Patients should not have received any radiation or hormonal therapy prior to surgery for any purpose
- Any prior prostate surgery
- No current or previous history of urinary incontinence requiring chronic pad use or treatments for urinary incontinence
- Patients may not be receiving any other investigational agents
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01821209
Start Date
April 1 2013
End Date
May 1 2015
Last Update
May 27 2015
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143-1695