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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2021-03-01

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.

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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.

Conditions

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Prostate Cancer Urinary Incontinence Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.

Study Groups

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Augmented Bladder Neck Reconstruction

Augmented Bladder Neck Reconstruction (Sling + Intussusception)

Group Type EXPERIMENTAL

Augmented Bladder Neck Reconstruction

Intervention Type PROCEDURE

Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception

Standard Bladder Neck Reconstruction

Standard Bladder Neck Reconstruction (Intussusception Only)

Group Type ACTIVE_COMPARATOR

Standard Bladder Neck Reconstruction

Intervention Type PROCEDURE

Standard Bladder Neck Reconstruction with Intussusception Only

Interventions

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Augmented Bladder Neck Reconstruction

Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception

Intervention Type PROCEDURE

Standard Bladder Neck Reconstruction

Standard Bladder Neck Reconstruction with Intussusception Only

Intervention Type PROCEDURE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No