Clinical trial NCT04305379: Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
Official title: Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Surgery
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 31
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: EPIC Urinary Incontinence subscale score
timeFrame: 1 Month
Secondary outcomes:
measure: EPIC Urinary Incontinence subscale score
timeFrame: 2 Weeks
measure: EPIC Urinary Incontinence subscale score
timeFrame: 3 Months
measure: EPIC Urinary Incontinence subscale score
timeFrame: 6 Months
measure: EPIC Urinary Incontinence subscale score
timeFrame: 12 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mohamad E Allaf, MD
role: PRINCIPAL_INVESTIGATOR
References: