Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

31

Study ID:

NCT04305379

Recruitment Status:

Terminated

Sponsor:

Johns Hopkins University

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There is 1 Location for this study

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Johns Hopkins Hospital
Baltimore Maryland, 21287, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

31

Study ID:

NCT04305379

Recruitment Status:

Terminated

Sponsor:


Johns Hopkins University

How clear is this clinincal trial information?

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