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Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling | Clinical Trials | Clareo Health

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

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

NCT00937833•Cook Group Incorporated

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (2)

Indiana University School of Medicine

Indianapolis, Indiana, United States

Urology of San Antonio Research

San Antonio, Texas, United States

Key Dates

Start Date

November 1, 2009

Primary Completion Date

October 1, 2013

Completion Date

November 1, 2014

Last Updated

December 29, 2014

Enrollment

150

ACTUAL participants

Conditions

Urinary IncontinenceProstate Cancer

Interventions

Prostatectomy

PROCEDURE

Surgisis Male Sling

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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