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

Not Applicable

Completed

• Conditions: Urinary Incontinence; Prostate Cancer

• Registration Number: NCT00937833
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Study Start: 2009-11
• Primary Completion: 2013-10
• Results First Submitted: 2014-10-01
• Study Completion: 2014-11
• Results First Submitted QC: 2014-11-05
• Results First Posted: 2014-11-13
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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 at least 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Continent Patients Post Prostatectomy	1 Month

Trial Locations

Locations (2)

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Urology of San Antonio Research; 🇺🇸 San Antonio, Texas, United States