Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI (NCT01878500) | Clinical Trial Compass
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 range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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