First-in-human bladder transplant demonstrates sustained function at 6 months

The first reported human bladder transplant has demonstrated sustained graft function, sensation, continence, spontaneous voiding, and no evidence of rejection more than 6 months after surgery, according to findings published in The Lancet.¹

According to the authors, the report represents the first proof-of-concept of vascularized bladder allograft transplantation in a human and provides early evidence that the procedure may be technically feasible in carefully selected patients with end-stage bladder dysfunction, particularly those who already require immunosuppression.

The case involved a 41-year-old man with end-stage kidney disease secondary to hypertension and a nonfunctional bladder who had undergone dialysis for 7 years. He received an ABO-compatible deceased-donor kidney and bladder transplant in May 2025 as part of an ongoing multicenter feasibility trial (NCT06337942 and NCT05462561).

According to the investigators, the approximately 8-hour operation was completed without intraoperative complications, and both grafts demonstrated excellent perfusion. Unlike conventional urinary reconstruction, the transplanted bladder was implanted as a vascularized organ with preservation of its native blood supply.

At 6 months, the patient maintained appropriate renal function, with an estimated glomerular filtration rate of approximately 52 to 55 mL/min/1.73 m². Functional bladder outcomes included intact sensation, appropriate urinary urge, spontaneous voiding, complete continence, complete emptying with negligible postvoid residual urine, and a maximum urinary flow rate of 17 mL/s. The patient also demonstrated a bladder capacity that increased from 270 mL at 30 days to 600 mL by 6 months, comparable to that of a healthy adult bladder.²

Serial cystoscopic evaluations and bladder biopsies performed through postoperative day 180 demonstrated healthy bladder mucosa without evidence of acute cellular or antibody-mediated rejection. The patient remained on maintenance immunosuppression with tacrolimus, mycophenolate mofetil, and prednisone.

The patient's postoperative course included 1 major (grade 4) complication. On postoperative day 25, he developed a urine leak originating from the suprapubic catheter tract accompanied by wound breakdown. Surgical repair, including abdominal washout, wound debridement, closure of the cystotomy, and removal of the suprapubic catheter, resulted in recovery without additional grade 3 or higher complications during follow-up.

Investigators also reported transient development of donor-specific antibodies, likely secondary to temporary discontinuation of mycophenolate mofetil during management of the wound complication. Following reinstitution of immunosuppressive therapy and administration of intravenous immunoglobulin, donor-specific antibodies became undetectable at month 3, and serial donor-derived cell-free DNA measurements remained below 1%, with the latest measurement at 0.04% at 6 months post-transplantation.

Ongoing work

The investigators designed the ongoing study specifically to evaluate vascularized composite bladder allograft transplantation in adults aged 18 to 70 years with poorly compliant, nonfunctional bladders. The investigators note that the trial is ideal for patients who already with pre-existing or concurrent immunosuppression requirement.

In a UCLA news release accompanying publication of the study, study author and urologic transplant surgeon Nima Nassiri, MD, said, “We learn from each procedure. Our hope is to help many more patients—especially those with end-stage bladder disease who haven’t had much hope for a normal life.”

According to the institution, investigators have since performed 2 additional combined kidney-bladder transplant procedures. One patient was reported to be recovering with spontaneous voiding approximately 2 months after surgery. Another patient reportedly required removal of the transplanted bladder because of a postoperative complication despite maintaining a functioning kidney transplant. This patient has since recovered, and the team is planning a potential second attempt to transplant the bladder.

“It’s not a fairy-tale story. These things happen,” Nassiri explained. “But the fact that you could re-transplant a bladder would tell us that even in the event of bladder failure, salvage may be possible and we may still be able to help these folks. That would guide future treatments and protocols for these patients.”

Despite the encouraging early findings, several limitations warrant consideration. The published report describes only a single patient with relatively short follow-up. Although the procedure met the study's primary end points of technical feasibility and safety, they emphasized that longer-term follow-up in additional patients will be necessary to better characterize long-term immunologic and functional outcomes, optimal immunosuppressive and immune-monitoring strategies, criteria for grading bladder allograft rejection, and the potential for bladder reinnervation.

REFERENCES
1. Nassiri N, Gill IS. Combined bladder-kidney transplantation: first-in-human feasibility trial. Lancet. 2026;408(10549):31-37. doi:10.1016/S0140-6736(26)00718-X

2. UCLA Health study documents successful one-year outcome following first-ever bladder transplant. News release. University of California – Los Angeles Health Sciences. June 24, 2026. Accessed July 20, 2026. https://www.uclahealth.org/news/release/ucla-health-study-documents-successful-one-year-outcome