NCT04305379

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

March 10, 2020

Last Update Submit

March 15, 2021

Conditions

Prostate CancerUrinary IncontinenceSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • EPIC Urinary Incontinence subscale score

    2 Weeks

  • EPIC Urinary Incontinence subscale score

    3 Months

  • EPIC Urinary Incontinence subscale score

    6 Months

  • EPIC Urinary Incontinence subscale score

    12 Months

Study Arms (2)

Augmented Bladder Neck Reconstruction

EXPERIMENTAL

Augmented Bladder Neck Reconstruction (Sling + Intussusception)

Procedure: Augmented Bladder Neck Reconstruction

Standard Bladder Neck Reconstruction

ACTIVE COMPARATOR

Standard Bladder Neck Reconstruction (Intussusception Only)

Procedure: Standard Bladder Neck Reconstruction

Interventions

Augmented Bladder Neck ReconstructionPROCEDURE

Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception

Augmented Bladder Neck Reconstruction
Standard Bladder Neck ReconstructionPROCEDURE

Standard Bladder Neck Reconstruction with Intussusception Only

Standard Bladder Neck Reconstruction

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamad E Allaf, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

January 16, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)