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

Study Overview
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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.

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

Conditions
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Urinary Incontinence, Prostate Cancer

Intervention / Treatment
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* Procedure: Prostatectomy
* Device: Surgisis Male Sling


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urethrovesical Sling<br>Surgisis Male Sling placed at the time of prostatectomy | Procedure: Prostatectomy<br> <br> Device: Surgisis Male Sling<br> <br> |
| Active Comparator: Control<br>Prostatectomy | Procedure: Prostatectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Continent Patients Post Prostatectomy |  | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, prostatectomy, incontinence