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

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.

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