This clinical trial is focused on evaluating a new treatment for urinary incontinence, a condition where individuals experience involuntary leakage of urine. This study is specifically for patients who have undergone a surgical procedure called radical prostatectomy, which is the removal of the prostate gland. The treatment being tested involves the use of autologous adipose-derived mesenchymal stem cells, which are special cells taken from a patient’s own fat tissue, expanded in a laboratory, and then injected back into the body. This treatment is referred to by the code name SUICell. The study will compare the effects of this treatment to a placebo to determine its effectiveness and safety.

Participants in the study will receive injections of the stem cell treatment or a placebo into the urethral sphincter, which is a muscle that helps control the release of urine. The main goal is to see if the treatment can reduce the amount of urine leakage, as measured by a pad test, and to monitor any side effects. The study will also assess the safety of the treatment over time. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

The study will take place over several years, with participants being monitored for changes in their urinary symptoms and any potential side effects. The researchers aim to determine if the stem cell treatment can improve bladder function and reduce symptoms of urinary incontinence. This trial represents an important step in finding new ways to help patients manage urinary incontinence after prostate surgery.