What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Prostate capsule-sparing radical cystectomy, or Nerve sparing radical cystectomy. The registry lists allocation as randomized. The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy.
They plan to enroll about 70 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer
Interventions: Prostate capsule-sparing radical cystectomy, Nerve sparing radical cystectomy
Primary outcome (registry wording): Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)