Urologic surgeons successfully complete world’s first bladder transplant

A groundbreaking milestone was reached earlier this month as urologic surgeons from the University of Southern California (USC) and the University of California, Los Angeles (UCLA) collaborated to successfully complete the world’s first-in-human bladder transplant.^1,2

The surgery took place at Ronald Reagan UCLA Medical Center. The procedure involved Inderbir S. Gill, MD, of USC and Nima Nassiri, MD, of UCLA, who worked together to develop the surgical technique, design the clinical trial, and obtain regulatory clearance for the procedure.

Inderbir S. Gill, MD

“This surgery is a historic moment in medicine and stands to impact how we manage carefully selected patients with highly symptomatic ‘terminal’ bladders that are no longer functioning,” said Gill, who is also chair and Distinguished Professor of Urology and Shirley and Donald Skinner chair in Urologic Cancer Surgery with the Keck School of Medicine of USC.^1,2 “Transplantation is a lifesaving and life-enhancing treatment option for many conditions affecting major organs, and now the bladder can be added to the list.”

The patient who underwent the bladder transplant had previously been on dialysis for 7 years due to having had both kidneys removed for renal cancer and pre-existing end-stage kidney disease. The patient also “had lost most of his bladder during a tumor removal, leaving the remainder too small and compromised to work,” according to the release.²

The entire procedure, which involved both kidney and bladder implantation, spanned approximately 8 hours.

“Despite the complexity of the case, everything went according to plan and the surgery was successful,” Gill reported.^1,2 “The patient is doing well, and we are satisfied with his clinical progress to date.”

Nima Nassiri, MD

Nassiri also added, “The kidney immediately made a large volume of urine, and the patient’s kidney function improved immediately. There was no need for any dialysis after surgery, and the urine drained properly into the new bladder.”^1,2

Bladder transplant is difficult because of the vascular structure of the pelvic area and the technical complexity of the procedure. As such, this milestone is the product of years of planning. Gill and Nassiri have worked closely on numerous practice transplantation surgeries, including robotic transplantations in 5 recently deceased donors who maintained cardiac function via ventilator support.

According to the surgeons, this feat opens to the door for more transplantations in select patients with terminal bladder diseases.

“This first attempt at bladder transplantation has been over 4 years in the making,” Nassiri said.^1,2 “For the appropriately selected patient, it is exciting to be able to offer a new potential option.”

However, patients must be carefully selected, according to the surgeons. The biggest risks include the potential for the body to reject the transplanted organ as well as the adverse effects caused by immunosuppressive drugs to prevent organ rejection.

“Because of the need for long-term immunosuppression, the best current candidates are those with a pre-existing organ transplant or those who need a combined kidney and bladder transplant,” Nassiri explained.^1,2

Now, the team will assess how well the transplanted bladder functions over time and determine how much immunosuppression will ultimately be needed.

Ongoing study

The surgery was performed as part of an ongoing clinical trial (NCT06337942) to assess the feasibility of bladder transplantation. Those enrolled in the study will receive either bladder-only or combined kidney and bladder transplantation. Patients will then be followed for 2 years to assess the efficacy, safety, and functionality of the procedure.^3,4

Those included in the study must be aged 18 to 70 years and have a positive history of either terminal bladder pathology or localized, non-metastatic bladder cancer requiring radical cystectomy. Participants on immunosuppression for previous solid organ transplantation are eligible. Patients must not have a co-existing medical condition that may affect the procedure nor any active co-existing psychosocial problems.

The primary outcome for the study is the technical success of the procedure. Secondary outcome measures include the incidence of adverse events, the incidence of immune rejection, and the functionality of the transplanted bladder.

Final completion of the study is planned for 2028.

REFERENCES

1. USC, UCLA team up for the world’s first-in-human bladder transplant. News release. Keck Medicine of USC. May 18, 2025. Accessed May 19, 2025. https://www.newswise.com/articles/usc-ucla-team-up-for-the-world-s-first-in-human-bladder-transplant

2. First human bladder transplant performed at UCLA. News release. University of California, Los Angeles (UCLA), Health Sciences. May 18, 2025. Accessed May 19, 2025. https://www.newswise.com/articles/first-human-bladder-transplant-performed-at-ucla

3. Deceased donor bladder or combined kidney-bladder transplantation: a phase 0 first-in-human study. UCLA Health. Accessed May 19, 2025. https://www.uclahealth.org/clinical-trials/deceased-donor-bladder-or-combined-kidney-bladder

4. Deceased donor bladder or combined kidney-bladder transplantation: a phase 0 first-in-human study. ClinicalTrials.gov. Last updated February 12, 2025. Accessed May 19, 2025. https://www.clinicaltrials.gov/study/NCT06337942