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

Cook Group Incorporated2 sites in 1 country150 target enrollmentNovember 2009

ConditionsUrinary Incontinence Prostate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: Cook Group Incorporated
Enrollment: 150
Locations: 2
Primary Endpoint: Number of Continent Patients Post Prostatectomy
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

November 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have organ confined prostate cancer.
•Patients must have PSA\<
•Patients must have clinical stage prostate cancer \< cT
•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
•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.