Neurogenic BladderNCT05462561
Vascularized Composite Bladder Allograft Transplantation
A study testing Quality-of-Life Assessment and Robotic Vascularized Composite Bladder Allograft Transplantation in people with Neurogenic Bladder and Bladder Dysfunction, run by University of Southern California at 1 site in United States.
Trial summary
This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurogenic Bladder, Bladder Dysfunction, Immunosuppression
- What is being tested?
- Quality-of-Life Assessment and Robotic Vascularized Composite Bladder Allograft Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 3 Oct 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Positive history of one of the following:
- Bladder pathology resulting in poor compliance, recurrent infections, and/or resultant upper tract (kidney and ureteral) pathology, demonstrated by hydronephrosis with resultant kidney disease.
- Localized, non-metastatic, muscle-invasive or lesser urothelial cell carcinoma of the bladder that requires therapeutic radical cystectomy will be considered only if the patient is already on pre-existing immunosuppression or who are expected candidates for immunosuppression in the near future, and then on a case-by-case basis after thorough evaluation and presentation to institutional tumor board committee. A minority of accrued patients are expected to have bladder cancer as the etiology of their cystectomy.
- Patients that are on pre-existing immunosuppression will be included in this study.
- Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.
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- Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing clean intermittent catheterization during pre-transplant workup.
- No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Exclusion Criteria below). If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of genitourinary transplantation. Examples of such medical conditions would include a burden of atherosclerotic disease that would preclude vascular anastomosis, and psychiatric disorders that would preclude reliable adherence to medications.
- No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).
- Negative crossmatch with donor.
- DONOR: Any potential brain dead donor considered for solid organ transplant.
- DONOR: Age 18-65 years.
- DONOR: Stable, meaning no requirement of excessive vasopressors for maintaining blood pressure.
- DONOR: ABO compatibility.
- DONOR: Negative cross-match with recipient.
Who cannot join
- Positive history of one of the following medical co-morbidities:
- Human immunodeficiency virus [HIV] (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus.
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thallassemia, sickle cell disease.
- Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including:
- Mixed connective tissue disorder
- Severe deforming rheumatoid arthritis
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- Infectious, post-infectious, or inflammatory (axonal or demyelinating) neuropathy
- Ehler-Danlos syndrome
- Lipopolysaccharidosis or amyloidosis (effects nerve regeneration).
- Impaired liver function as evaluate by liver function panel, including the presence of hyperbilirubinemia, elevated aspartate aminotransferase/ alanine aminotransferase (AST/ALT), and the presence of secondary coagulopathy, measured by prothrombin, international normalized ratio, and partial thromboplastin time.
- Severe anemia (hemoglobin < 7 g/dL), leukopenia (WBC < 3 x 10 ^ 9 cell/L), or thrombocytopenia (platelets < 20 x10 ^ 9 cells/L).
- Oncology patient specific:
- History of any non-urothelial malignancy within the past 5 years, with the exception of non-melanomatous skin cancer and very-low to low risk prostate cancer on active surveillance.
- History of metastasic malignancy within the past 5 years.
- History of urothelial carcinoma in patients without pre-existing conditions that require immunosuppression and/or without the expected need for immunosuppression in the future.
- Sensitized recipients; panel reactive antibody (PRA) < 80%, with negative crossmatch to donor and no evidence of donor-specific antibody at time of transplant.
- Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.
- Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.
- Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.
- Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no "score" on any particular evaluation that would rule out a patient, certain factors can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting (per University of Southern California Transplant Center Policy). In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made. Towards these ends, a two-part initial psychiatric consultation will be rendered in addition to psychosocial evaluations already accounted for in the social work and transplantation evaluation prior to listing. The first visit focuses on background history and standard contraindications to transplantation, while the second visit is a more thorough discussion of the challenges ahead for the potential recipient and how these challenges relate to their strengths and vulnerabilities. If at this phase, or any subsequent one, significant psychological need emerges, the patient will be referred to another mental health professional for ongoing treatment with frequent communication between that provider and the transplant psychiatrist. The same psychiatrist responsible for listing and taking part in the protocol will not provide this treatment, given the potentially conflicting obligations involved and the disincentive present for the patient to be completely honest. If a greater than 6 month period of time elapses between listing and transplantation, a follow-up visit with psychiatry and social work will be arranged.
- DONOR: Unresolved sepsis.
- DONOR: Known history of urothelial or prostate cancer/malignancy.
- DONOR: Known history of bladder or prostate surgery.
- DONOR: Abnormal bladder capacity.
- DONOR: Active sexually transmitted disease.
- DONOR: Active cytomegalovirus (CMV), Epstein-Barr virus (EBV), or tuberculosis (TB) infections.
- DONOR: Hepatitis B virus (HBV) core antibody, surface antigen, or DANN positive.
- DONOR: Hepatitis C virus (HCV) antibody or viral load+.
- DONOR: Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Robotic Vascularized Composite Bladder Allograft Transplantation: A Phase 0 (First-in-Human), Single Institutional Study for Deceased-Donor Bladder Transplantation
This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. A vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to standard urinary diversion, which employs bowel. A robotic surgical approach will be employed.
Read the detailed description
PRIMARY OBJECTIVE:
- To perform a feasibility study of vascularized composite bladder allograft (VCBA) transplantation and demonstrate successful transplantation of a vascularized composite deceased-donor bladder allograft.
SECONDARY OBJECTIVES:
- To describe the adverse events associated with VCBA transplantation.
II. To describe the immunosuppression regimen for patients undergoing VCBA transplantation.
III. To evaluate allografted bladder functionality (storage and emptying) after transplantation.
OUTLINE:
This study will be the first to report on the feasibility of human bladder transplantation. In the appropriately selected candidate, a vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to urinary diversion using the bowel. The objective of this study is to perform successful, safe robotic genitourinary bladder allotransplantation and define the optimal surgical techniques in up to 5 genitourinary patients using standard triple-therapy immunosuppression. A multi-institutional, multidisciplinary Genitourinary Vascularized Composite Bladder Allograft Transplantation Team has been established to address this aim.
Brain dead donors who have met the criteria for Determination of Death will be selected by the Genitourinary transplant team in conjunction with the organ procurement organization (OPO) for the University of Southern California, OneLegacy. The mandatory requirements are family consent for donation. These criteria are standard and are not part of the research question at hand.
A robotic vascularized composite bladder allograft transplantation will be performed, after which patients will be monitored closely as both an inpatient and at serial timepoints after surgery in the outpatient setting.
This is the critical period when most of the surgical complications leading to allografts loss can take place. During this period, VCBA recipients will remain at the Keck USC Urology Step-down Unit for 7 days following the surgery, from where they will be moved to the regular floor. Daily examinations and post-operative ultrasound evaluation will be performed by the urology service to monitor for signs of rejection. The patient will have protocol biopsies as detailed below and during any rejection episodes. Once drug levels are stable and therapeutic and the patient is without complications, the process of discharge with close follow-up will be initiated.
Immediately after surgery, discharge will typically occur 1-3 weeks following transplantation. A detailed explanation of postoperative discharge instructions will be provided by the discharge nurse, social worker, and transplant coordinator and will include: medication dosages and associated adverse effect profiles (the patient will be instructed to record the time of all medications taken); schedule of required laboratory draws; timing of physician follow-up visits; wound care; assessment of urine output; diet; monitoring of blood pressure and temperature; hygiene; dental care; opportunistic infection prevention; use of gloves and masks; activity and exercise; maintaining a nonsmoking environment; driving; child immunization; caring for house pets; and other special instructions. The endpoint is the success of the transplant, measured by adequate blood flow and no signs of complications.
Evaluation of bladder integrity, including urine output, will be an essential component of transplant surveillance. In addition, graft biopsies will be routinely performed at one month after surgery and every 3 months through cystoscopy during the first year, plus whenever clinically indicated. Biopsies are taken from the bladder dome during in-office cystoscopy. Hemostasis is achieved through Bugby electrocautery. This is a common urologic procedure performed in outpatient surgery centers and urology clinics nationwide. The clinical care needs of each patient will likely be individually different after genitourinary transplantation and will thus be adjusted specifically per patient. Daily monitoring of the quality and quantity of urine output is considered clinically particularly relevant for monitoring graft rejection. Briefly, allograft recipients need to visit the transplant clinic staff once a week for the 1st post-operative month, then once every other week for 1 month, then once monthly for 6 months, and thereafter once every 3 months for the management of immunosuppression and assessment of rejection.
- Conditions
- Neurogenic Bladder, Bladder Dysfunction, Immunosuppression
- Being tested
- Quality-of-Life Assessment, Robotic Vascularized Composite Bladder Allograft Transplantation
- Keywords
- neurogenic bladder, vascularized composite allograft
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Robotic Vascularized Composite Bladder Allograft TransplantationProcedure or surgery
Undergo robotic VCBA transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (VCBA) | Experimental | Patients undergo robotic VCBA transplantation. Receives: Other: Quality-of-Life Assessment; Procedure: Robotic Vascularized Composite Bladder Allograft Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of vascularized composite bladder allograft (VCBA) transplantation
Defined as appropriate vascularization of the transplanted bladder, measured through intraoperative fluorescence imaging and immediate post-operative computed tomographic angiography.
Measured: At completion of transplantation procedure
Secondary outcomes (3)
Adverse events associated with VCBA transplantation
Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 criteria will be used to describe adverse events. A rejection episode managed medically will be defined as a grade 3 adverse event, while rejection requiring allograft explanation will be graded as a CTCAE grade 4 event.
Measured: Immediately peri-operative and 30 and at 90 days after transplantation
Transplant rejection
Rejection will be graded using a modified histological grading system adapted from Banff criteria, similar to that adopted in uterine transplantation.
Measured: Up to 1 year within 7 days post-transplantation
Bladder function
Defined by measurements of bladder capacity. The 30 and 90 day timepoints will include cystoscopic evaluation and the 90 day timepoint urodynamic evaluation.
Measured: At 7, 30, 90, 180, and 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 May 2023
- Primary completion3 Oct 2027 (estimated)
- Study completion3 Oct 2028 (estimated)
Why it stopped: pending UNOS approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 5 total: * 1 patient will be accrued for feasibility, and monitored for a period of 3 months. * If successful, defined as the absence of life-threatening complication, including allograft rejection requiring explantation, and adequate bladder storage, accrual of the remaining 4 patients will ensue.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Inderbir Gill, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462561
- Sponsor's protocol ID
- 4B-21-5
- Other IDs
- NCI-2022-00076, 4B-21-5, P30CA014089
- Status last verified
- Jun 2026
- First submitted
- 14 Jul 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nassiri N, Gill IS. Combined bladder-kidney transplantation: first-in-human feasibility trial. Lancet. 2026 Jul 4;408(10549):31-37. doi: 10.1016/S0140-6736(26)00718-X. Epub 2026 Jun 23.
PubMed 42335920
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Vascularized Composite Bladder Allograft Transplantation: A Phase 0 (First-in-Human), Single Institutional Study for Deceased-Donor Bladder Transplantation
- ClinicalTrials.gov ID
- NCT05462561
- Acronym / sponsor ID
- 4B-21-5
- Conditions
- Neurogenic Bladder, Bladder Dysfunction, Immunosuppression
- Keywords
- neurogenic bladder, vascularized composite allograft
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: pending UNOS approval
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 3 Oct 2027 (estimated)
- Study completion
- 3 Oct 2028 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 0 trial tests the feasibility, functionality, and sustainability of vascularized composite bladder allograft transplantation in treating patients with terminal bladder pathology. A vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to standard urinary diversion, which employs bowel. A robotic surgical approach will be employed.
Detailed description
PRIMARY OBJECTIVE:
- To perform a feasibility study of vascularized composite bladder allograft (VCBA) transplantation and demonstrate successful transplantation of a vascularized composite deceased-donor bladder allograft.
SECONDARY OBJECTIVES:
- To describe the adverse events associated with VCBA transplantation.
II. To describe the immunosuppression regimen for patients undergoing VCBA transplantation.
III. To evaluate allografted bladder functionality (storage and emptying) after transplantation.
OUTLINE:
This study will be the first to report on the feasibility of human bladder transplantation. In the appropriately selected candidate, a vascularized bladder allograft transplantation may provide a more durable and better-tolerated alternative to urinary diversion using the bowel. The objective of this study is to perform successful, safe robotic genitourinary bladder allotransplantation and define the optimal surgical techniques in up to 5 genitourinary patients using standard triple-therapy immunosuppression. A multi-institutional, multidisciplinary Genitourinary Vascularized Composite Bladder Allograft Transplantation Team has been established to address this aim.
Brain dead donors who have met the criteria for Determination of Death will be selected by the Genitourinary transplant team in conjunction with the organ procurement organization (OPO) for the University of Southern California, OneLegacy. The mandatory requirements are family consent for donation. These criteria are standard and are not part of the research question at hand.
A robotic vascularized composite bladder allograft transplantation will be performed, after which patients will be monitored closely as both an inpatient and at serial timepoints after surgery in the outpatient setting.
This is the critical period when most of the surgical complications leading to allografts loss can take place. During this period, VCBA recipients will remain at the Keck USC Urology Step-down Unit for 7 days following the surgery, from where they will be moved to the regular floor. Daily examinations and post-operative ultrasound evaluation will be performed by the urology service to monitor for signs of rejection. The patient will have protocol biopsies as detailed below and during any rejection episodes. Once drug levels are stable and therapeutic and the patient is without complications, the process of discharge with close follow-up will be initiated.
Immediately after surgery, discharge will typically occur 1-3 weeks following transplantation. A detailed explanation of postoperative discharge instructions will be provided by the discharge nurse, social worker, and transplant coordinator and will include: medication dosages and associated adverse effect profiles (the patient will be instructed to record the time of all medications taken); schedule of required laboratory draws; timing of physician follow-up visits; wound care; assessment of urine output; diet; monitoring of blood pressure and temperature; hygiene; dental care; opportunistic infection prevention; use of gloves and masks; activity and exercise; maintaining a nonsmoking environment; driving; child immunization; caring for house pets; and other special instructions. The endpoint is the success of the transplant, measured by adequate blood flow and no signs of complications.
Evaluation of bladder integrity, including urine output, will be an essential component of transplant surveillance. In addition, graft biopsies will be routinely performed at one month after surgery and every 3 months through cystoscopy during the first year, plus whenever clinically indicated. Biopsies are taken from the bladder dome during in-office cystoscopy. Hemostasis is achieved through Bugby electrocautery. This is a common urologic procedure performed in outpatient surgery centers and urology clinics nationwide. The clinical care needs of each patient will likely be individually different after genitourinary transplantation and will thus be adjusted specifically per patient. Daily monitoring of the quality and quantity of urine output is considered clinically particularly relevant for monitoring graft rejection. Briefly, allograft recipients need to visit the transplant clinic staff once a week for the 1st post-operative month, then once every other week for 1 month, then once monthly for 6 months, and thereafter once every 3 months for the management of immunosuppression and assessment of rejection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 5 total: * 1 patient will be accrued for feasibility, and monitored for a period of 3 months. * If successful, defined as the absence of life-threatening complication, including allograft rejection requiring explantation, and adequate bladder storage, accrual of the remaining 4 patients will ensue.
| Arm | Type | Receives |
|---|---|---|
| Treatment (VCBA) | Experimental | Other: Quality-of-Life Assessment, Procedure: Robotic Vascularized Composite Bladder Allograft TransplantationPatients undergo robotic VCBA transplantation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-80 years.
- Positive history of one of the following:
- Patients that are on pre-existing immunosuppression will be included in this study.
- Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.
- Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing clean intermittent catheterization during pre-transplant workup.
Key exclusion criteria (29 listed)
- Positive history of one of the following medical co-morbidities:
- Oncology patient specific:
- Sensitized recipients; panel reactive antibody (PRA) < 80%, with negative crossmatch to donor and no evidence of donor-specific antibody at time of transplant.
- Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.
- Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (VCBA) |
| Robotic Vascularized Composite Bladder Allograft TransplantationUndergo robotic VCBA transplantation. | Procedure or surgery | Treatment (VCBA) |
Primary outcome
Technical success of vascularized composite bladder allograft (VCBA) transplantation
Time frame: At completion of transplantation procedure
Defined as appropriate vascularization of the transplanted bladder, measured through intraoperative fluorescence imaging and immediate post-operative computed tomographic angiography.
3 secondary outcomes
Adverse events associated with VCBA transplantation
Time frame: Immediately peri-operative and 30 and at 90 days after transplantation
Transplant rejection
Time frame: Up to 1 year within 7 days post-transplantation
Bladder function
Time frame: At 7, 30, 90, 180, and 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 42335920Nassiri N, Gill IS. Combined bladder-kidney transplantation: first-in-human feasibility trial. Lancet. 2026 Jul 4;408(10549):31-37. doi: 10.1016/S0140-6736(26)00718-X. Epub 2026 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inderbir Gill principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment and Robotic Vascularized Composite Bladder Allograft Transplantation in people with Neurogenic Bladder and Bladder Dysfunction, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of vascularized composite bladder allograft (VCBA) transplantation (time frame: At completion of transplantation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.