NCT04305379

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Prostate Cancer
• Urinary Incontinence
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Augmented Bladder Neck Reconstruction	Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception
PROCEDURE	Standard Bladder Neck Reconstruction	Standard Bladder Neck Reconstruction with Intussusception Only

Timeline

• Start date: 2020-01-16
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-03-12
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States