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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04305379
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Urinary Incontinence; Surgery	Procedure: Augmented Bladder Neck Reconstruction; Procedure: Standard Bladder Neck Reconstruction	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.
• Primary Purpose: Prevention
• Official Title: Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
• Actual Study Start Date: Jan 16, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Augmented Bladder Neck Reconstruction Augmented Bladder Neck Reconstruction (Sling + Intussusception)	Procedure: Augmented Bladder Neck Reconstruction; Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception
Active Comparator: Standard Bladder Neck Reconstruction Standard Bladder Neck Reconstruction (Intussusception Only)	Procedure: Standard Bladder Neck Reconstruction; Standard Bladder Neck Reconstruction with Intussusception Only

Outcome Measures

Primary Outcome Measures

1. EPIC Urinary Incontinence subscale score [1 Month]

   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).

Secondary Outcome Measures

1. EPIC Urinary Incontinence subscale score [2 Weeks]

   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. EPIC Urinary Incontinence subscale score [3 Months]

   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. EPIC Urinary Incontinence subscale score [6 Months]

   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).

4. EPIC Urinary Incontinence subscale score [12 Months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Mohamad E Allaf, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04305379
• Other Study ID Numbers: IRB00208651
• First Posted: Mar 12, 2020
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence

Study Results

No Results Posted as of Mar 17, 2021