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

NCT04305379 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Mohamad E Allaf, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305379 on ClinicalTrials.gov