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

NCT ID: NCT00937833

Last Updated: 2014-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Urinary Incontinence Prostate Cancer

Keywords

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prostate cancer prostatectomy incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Urethrovesical Sling

Surgisis Male Sling placed at the time of prostatectomy

Group Type EXPERIMENTAL

Prostatectomy

Intervention Type PROCEDURE

Surgisis Male Sling

Intervention Type DEVICE

Control

Prostatectomy

Group Type ACTIVE_COMPARATOR

Prostatectomy

Intervention Type PROCEDURE

Interventions

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Prostatectomy

Intervention Type PROCEDURE

Surgisis Male Sling

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chandru Sundaram, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana Cancer Pavilion

Locations

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Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Urology of San Antonio Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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350017

Identifier Type: -

Identifier Source: secondary_id

08-015

Identifier Type: -

Identifier Source: org_study_id