Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy

Study Overview
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Brief Summary
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The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.

Detailed Description
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A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial. The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis. The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.

Official Title
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Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy

Conditions
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Surgery, Prostate Cancer, Urinary Incontinence

Intervention / Treatment
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* Procedure: Augmented Bladder Neck Reconstruction
* Procedure: Standard Bladder Neck Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases) Scheduled to undergo curative robot-assisted radical prostatectomy Exclusion Criteria: Planned pre-operative or post-operative (within 1 month) androgen therapy Planned pre-operative or post-operative (within 1 month) radiation therapy History of spinal trauma or surgery to the brain or spinal cord Pre-operative history of stress urinary incontinence

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Bladder Neck Reconstruction<br>Augmented Bladder Neck Reconstruction (Sling + Intussusception) | Procedure: Augmented Bladder Neck Reconstruction<br>* Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception<br>|
| Active Comparator: Standard Bladder Neck Reconstruction<br>Standard Bladder Neck Reconstruction (Intussusception Only) | Procedure: Standard Bladder Neck Reconstruction<br>* Standard Bladder Neck Reconstruction with Intussusception Only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPIC Urinary Incontinence subscale score | Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence). | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPIC Urinary Incontinence subscale score | Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence). | 2 Weeks | 
| EPIC Urinary Incontinence subscale score | Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence). | 3 Months | 
| EPIC Urinary Incontinence subscale score | Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence). | 6 Months | 
| EPIC Urinary Incontinence subscale score | Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence). | 12 Months |