Concomitant Renal and Urinary Bladder Allograft Transplantation
Mayo Clinic
Summary
The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
Description
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…
Eligibility
- Age range
- 1–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patients between 1 yr. and 60 years of age. * Subject is willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children 6-17 years of age as appropriate or warranted. * Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder. * Medical need for a bladder transplant, as defined by the presence of exhibiting "hostile bladders" defined as end filling pressure or detrusor leak…
Interventions
- ProcedureConcomitant Renal and Urinary Bladder Allograft Transplantation
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. Patients will undergo a cadaveric donor bladder transplant in addition to or after their kidney transplant rather than using intestinal segments for bladder reconstruction or contruction.
Locations (2)
- Mayo ClinicRochester, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota