Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI

The aim of this study is to investigate the use of intraoperative stereotactic imaging of the pelvic floor musculature during closure of bladder exstrophy.

Study Overview

• Status: Completed
• Conditions: Bladder Exstrophy
• Intervention / Treatment: Device: Intraoperative stereotactic imaging with VectorVision

Detailed Description

Much of the long-term success of classic bladder exstrophy closures depends on the initial closure. Several studies have demonstrated that a key to successful initial closure involves deep dissection of the pelvic floor so that the bladder can be placed in the most posterior and inferior position possible. Oftentimes, the need for repeat closure of the abdomen is required if the initial surgeon failed to properly dissect deep enough into the child's pelvic floor. Many surgeons are unfamiliar with the complex anatomy and are unable to verify that they have properly reached the true pelvic floor during this initial surgery. This often leads to failed closures, which result in poor continence rates later in life.

The investigators are attempting to determine the safety and efficacy of the use the Brainlab, Inc. VisionVector® Cranial Image Guided Surgery System during closure of bladder exstrophy. The value of this research is two-fold. Firstly, the project will help us to verify if the investigators are indeed dissecting down to the proper plane required for successful initial closure of bladder exstrophy. Secondly, this project will help others with relatively less experience with bladder exstrophy to properly identify where they are anatomically during closure of exstrophy, thus yielding higher success rates and better patient care at other centers.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Brady Urological Institute. Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 0-7 years
2. Diagnosis of classic bladder exstrophy
3. Scheduled to undergo bladder exstrophy closure by the principal investigator at Johns Hopkins Hospital's Broadway campus.
4. All eligible participants will be children whose parents or legally authorized representatives have already agreed and are being scheduled for osteotomy and bladder exstrophy closure as determined by their pediatric urologist.
5. Parent or legally authorized representative who is, in the opinion of the investigator, reliable and willing to make themselves and patient available for the duration of the study.
6. Parent or legally authorized representative is able to complete and sign the informed consent document.
7. Patient judged by the investigator to have bladders of sufficient size and elasticity to be suitable for immediate closure as evidenced by the PI's assessment of the patient's bladder template [16].
8. Patient with cardiopulmonary function sufficient to tolerate general anesthesia as evidenced by the pediatrician's and anesthesiologists assessment of the patient's overall cardio-pulmonary status.
9. Patients requiring ferromagnetic metal objects such as a metal pace maker during the OR procedure.

Exclusion Criteria:

1. Lack or withdrawal of consent for primary operative procedure.
2. Parent or legally authorized representative who is, in the opinion of the investigator, not reliable or unwilling to make themselves and patient available for the duration of the study.
3. Parent or legally authorized representative who is unable to understand, complete and/or sign the informed consent document. Non-English speaking parents will automatically be excluded if they are unable to read and understand the consent form.
4. Patient who will not undergo osteotomy prior to closure for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Intraoperative stereotactic imaging; Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure.

Device: Intraoperative stereotactic imaging with VectorVision; Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.; Other Names: VectorVision® Cranial Guided Image System by Brainlab Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success or Failure of Exstrophy Closure	A failed bladder closure was defined as bladder prolapse, dehiscence, outlet obstruction, persistent vesicourethral fistula, or a combination of these, or a complication that required repeat closure.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Continence	Continence rates as determined by total dry time during the day, number of incontinent episodes, and need for dry pads.	2 years
Operative Time	Time (measured in minutes) of operation.	Intraoperatively
Length of Hospital Stay	Length of hospital stay (in days) for each participant.	Up to 2 months
Peri-operative Complications as Assessed by the Total Number of Transfusions	Peri-operative complications were those encountered immediately before, during, or immediately following the case, primarily regarding need for blood transfusions. Though these are not complications (and deemed necessary/inherent to the operation), they are tracked closely as an outcome measure.	Intraoperatively
Subjective Improved Identification of the Pelvic Floor Anatomy During Bladder Exstrophy Closure as Reported by the Surgeon	Surgeon's were surveyed post-operatively on whether the intervention improved identification of pelvic floor anatomy. Measure: Binary, 'Yes' and 'No'	Intraoperatively
Total Number of Post-operative Complications	Post-operative complications were graded on the Clavien-Dindo Classification System. The Clavien-Dindo System is a standardized classification for reporting and registering complications. It grades the severity of a complication based on the therapy required to treat the complication. It is a tiered system with subdivided categories as follows: Grade I and II are considered minor, Grade III is considered moderate and Grades IV and V are severe complications.	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (ESTIMATE): June 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Bladder exstrophy epispadias complex; Pelvic floor musculature; Intraoperative stereotactic imaging
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urogenital Abnormalities; Congenital Abnormalities; Bladder Exstrophy
• Other Study ID Numbers: NA_00069579