CompletedNot Applicable

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

United States48 participantsStarted 2012-09

Plain-language summary

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

Who can participate

Age range7 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Success or Failure of Exstrophy Closure

Timeframe: 2 years

Trial details

NCT IDNCT01878500

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

Results submitted2021-10-18

View on ClinicalTrials.gov More Bladder Exstrophy trials