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

Not Applicable

Completed

• Conditions: Urinary Incontinence; Prostate Cancer
• Interventions: Procedure: Prostatectomy; Device: Surgisis Male Sling

• 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

Arm && Interventions

Group	Intervention	Description
Urethrovesical Sling	Surgisis Male Sling	Surgisis Male Sling placed at the time of prostatectomy
Urethrovesical Sling	Prostatectomy	Surgisis Male Sling placed at the time of prostatectomy
Control	Prostatectomy	Prostatectomy

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