Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling



Status:Completed
Conditions:Prostate Cancer, Cancer, Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/30/2013
Start Date:November 2009
End Date:December 2014
Contact:Jason Hodde
Email:hodde@cookbiotech.com

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Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling


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.


Inclusion Criteria:

- 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 > 18 years of age.

Exclusion Criteria:

- Patients must not have previously undergone transurethral resection, laser therapy,
microwave therapy, radiofrequency ablation, or other surgery of the prostate.

- Patients must not have a prostate size >100 cc as measured on digital rectal
examination or transrectal ultrasound.

- 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 by a negative
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.
We found this trial at
3
sites
Carmel, Indiana 46032
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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San Antonio, Texas 78229
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San Antonio, TX
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