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

Completed · Not applicable

Conditions studied: Urinary Incontinence, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00937833

Run by

Cook Group Incorporated

People needed

150

Starts

2009-11-01

Expected to finish

2014-11-01

Last updated by the study team

2014-12-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Urology of San Antonio Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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