Concomitant Renal and Urinary Bladder Allograft Transplantation

Overview

About this study

Patients that need reconstruction or re-building of their urinary bladder are often limited to having a segment of their intestine used for that purpose. Using intestine is less than ideal as it is an absorptive, mucous producing tissue and placing this in constant contact with urine creates significant long term problems. In patients that require a kidney transplant and bladder reconstruction, this study seeks to use a bladder graft from a deceased donor rather than intestine.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Male or female patients between 1 yr. and 60 years of age.
  2. 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.
  3. Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder.
  4. Medical need for a bladder transplant, as defined by the presence of
    1. Exhibiting “hostile bladders” defined as end filling pressure or detrusor leak point pressure (DLPP) of or greater than 40 cm H20 or at below estimated bladder capacity for age, or
    2. Detrusor overactivity with detrusor sphincter dyssynergia, or
    3. New onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months
  5. If a concomitant kidney transplant is being considered, additionally, estimated GFR less than or equal to 20 mL/min or dialysis. If GFR 20-25 mL/min would also qualify if expected progression is rapid (>10 mL/min/year)
  6. Vetting and approval by the Mayo Clinic multidisciplinary transplant team (MDC) for renal transplantation.
  7. Ability of subject and/or care provider to be successfully trained in clean intermittent catheterization and bladder cycling. Or current use of CIC.
  8. Utilization of maximally-tolerated dose and regimen of medical therapy (e.g. anticholinergics) or failure to tolerate/contraindications to such agents.
  9. Psychosocial clearance: Demonstrated commitment to psychological evaluation perioperatively, in which the psychologist must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study.
  10. Agree to avoid pregnancy for 1 year after surgery through abstinence or approved contraception as noted in Appendix A (female subjects only)

Exclusion Criteria:

  1. They are pregnant or breastfeeding, or planning a pregnancy during the course of the study, or who are of child bearing potential and not willing to continue using an effective method of birth control (i.e. with a low failure rate of less than 1 percent per year including injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner), or
  2. Any contraindication to general anesthesia  or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative recovery due to severe cardiovascular, pulmonary, neurological, metabolic, or rheumatologic disease (requires special consultation)
  3. Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
  4. Subjects with a current positive (>=5 mm induration for high-risk subjects; otherwise >=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.
  5. Known history of hypersensitivity to aminoglycosides or fluoroquinolones
  6. Use of any investigational product within 3 months
  7. Prior participation in the study
  8. Currently smoking
  9. Current incarceration for any reason
  10. Unwillingness, inability, or unlikely compliance of individual and/or primary caregiver with study related schedules procedures, management, or follow –up in the opinion of the PI and/or co-investigators
  11. Any circumstance in which the investigator deems participation in the study is not in the subject’s best interest
  12. Subjects with an ALT or AST value >3 times the upper limit of normal
  13. Subjects with acute or chronic abdominal skin infections and/or acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease
  14. Subjects with uncontrolled diabetes defined as HgA1c>10, unstable cardiac and/or pulmonary disorders, or bleeding disorders
  15. Active malignant neoplasm (with the exception of localized non-melanoma skin cancer) that is untreated, unresponsive to available treatment, or too recently treated to determine relapse risk (time to determination of relapse risk will vary depending on type of neoplasm)
  16. Surgical procedure for transplantation cannot be successfully performed for anatomical reasons
  17. Life expectancy with successful transplantation is estimated to be <5 years for any reason.
  18. There is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the procedure or the interpretation of results or render the subject at high risk for treatment complications, or
  19. Serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits/care after transplant, or
  20. Taking medications on specified hourly intervals that may be affected by changes to renal clearance, or
  21. Hypertension stage II > 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or
  22. Presence of  severe coagulopathy, (hyper or hypo)
  23. Patient is not up to date on current CDC recommended vaccines

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patricio Gargollo, M.D.

Contact us for the latest status

Contact information:

Morgan Swope B.S.

(507) 293-0168

Swope.Morgan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available