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

Completed · Not applicable

Conditions studied: Bladder Exstrophy

In brief

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

Key facts

Study ID

NCT01878500

Run by

Johns Hopkins University

People needed

48

Starts

2012-09-01

Expected to finish

2020-12-31

Last updated by the study team

2021-12-21

Who can join

Age: any, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 0-7 years
• Diagnosis of classic bladder exstrophy
• Scheduled to undergo bladder exstrophy closure by the principal investigator at Johns Hopkins Hospital's Broadway campus.
• 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.
• 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.
• Parent or legally authorized representative is able to complete and sign the informed consent document.
• 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].
• 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.
• Patients requiring ferromagnetic metal objects such as a metal pace maker during the OR procedure.

You may not qualify if…

• Lack or withdrawal of consent for primary operative procedure.
• 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.
• 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.
• Patient who will not undergo osteotomy prior to closure for any reason

Where it is running

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

Full record on ClinicalTrials.gov

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