Status:
COMPLETED
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Lead Sponsor:
Cook Group Incorporated
Conditions:
Urinary Incontinence
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
Eligibility Criteria
Inclusion
- Patients must have organ confined prostate cancer.
- Patients must have PSA\< 15.
- Patients must have clinical stage prostate cancer \< cT3.
- Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
- Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
- Patients must be at least 18 years of age.
Exclusion
- Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
- Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
- Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
- Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
- Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
- Patients must not have a prior history of radiation to the pelvis.
- Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
- Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00937833
Start Date
November 1 2009
End Date
November 1 2014
Last Update
December 29 2014
Active Locations (2)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
2
Urology of San Antonio Research
San Antonio, Texas, United States, 78229