A Phase I Study of a Neo-Urinary Conduit in Patients Requiring Urinary Diversion After Bladder Removal

Urine flows from the kidneys into the bladder through tubes called the ureters. When a patient has his or her bladder surgically removed (a procedure called “cystectomy”) as a treatment for bladder cancer, the surgeon may construct a new tube, or conduit, through which urine can flow from the kidneys into a bag outside the body. Typically, this “incontinent urinary diversion” is constructed using tissue from the patient’s own bowel, but this approach causes complications in some patients.

In this study, researchers are evaluating the safety and effectiveness of a “neo-urinary conduit” (NUC) in patients with bladder cancer who are having cystectomy. To create the NUC, a small sample of fat tissue is removed from the patient’s abdomen and sent to a laboratory, where smooth muscle cells from the fat tissue are grown. The patients’ cells are then placed inside a tube-shaped scaffold, where they attach and grow to form a conduit that can be implanted in the patient during cystectomy.

After the cancerous bladder is removed, the NUC is attached to the ureters at one end and to a bag outside the patient’s body. Over time, the patient’s body is expected to regenerate urinary tissue and the scaffold is absorbed, leaving the new conduit in place.