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

Prostate Cancer Clinical Trial

— BLANKET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04305379
• Other study ID #: IRB00208651
• Status: Terminated
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Surgery
• Urinary Incontinence

Intervention

Procedure:
• Augmented Bladder Neck Reconstruction
Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception
• Standard Bladder Neck Reconstruction
Standard Bladder Neck Reconstruction with Intussusception Only

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPIC Urinary Incontinence subscale score	Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).	1 Month
Secondary	EPIC Urinary Incontinence subscale score	Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).	2 Weeks
Secondary	EPIC Urinary Incontinence subscale score	Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).	3 Months
Secondary	EPIC Urinary Incontinence subscale score	Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).	6 Months
Secondary	EPIC Urinary Incontinence subscale score	Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).	12 Months