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

Cook Group

Status: Completed

Conditions: Prostate Cancer; Urinary Incontinence

Treatments: Procedure: Prostatectomy; Device: Surgisis Male Sling

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937833

08-015 (Other Identifier)

350017

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Urethrovesical Sling

Experimental group

Description:

Surgisis Male Sling placed at the time of prostatectomy

Treatment:

Procedure: Prostatectomy

Device: Surgisis Male Sling

Control

Active Comparator group

Description:

Prostatectomy

Treatment:

Procedure: Prostatectomy