The purpose of this study is to establish if concomitant renal and vascularized urinary
bladder allograft transplantation is feasible.
This is a single-center, prospective, single-group unblinded phase I study that will enroll
subjects with chronic kidney disease secondary to bladder dysfunction or bladder absence that
is refractory to medical treatment and requires surgical intervention to prevent long-term
sequelae. The primary inclusion criteria will be patients who are diagnosed with chronic
kidney disease secondary to disorders involving the urinary bladder or absence of a urinary
bladder. Patients exhibiting "hostile bladders" defined as end filling pressure or detrusor
leak point pressure (DLPP) of 40 cm H2O or greater as measured by urodynamic studies or
detrusor overactivity with detrusor sphincter dyssynergia will be included. Candidates for
renal transplantation will be vetted and approved by the Mayo Clinic multidisciplinary
transplant team (MDC). Subjects meeting these primary inclusion criteria can be referred to
the PI, co-investigators, or study coordinator to approach for possible participation in this
If the subject still meets all the inclusion and exclusion criteria after the baseline
evaluations are completed, the subject will undergo concomitant renal and vascularized
urinary bladder allograft transplantation.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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