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

Stopped early · Not applicable

Conditions studied: Prostate Cancer, Urinary Incontinence, Surgery

In brief

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.

Key facts

Study ID

NCT04305379

Run by

Johns Hopkins University

People needed

31

Starts

2020-01-16

Expected to finish

2021-03-01

Last updated by the study team

2021-03-17

Who can join

Age: 40 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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