Evaluation of the Safety of Somatic Cell-Based Therapy for Post-Radical Prostatectomy Urinary Incontinence: An Open-Label Clinical Trial

The primary objective of this clinical trial is to evaluate the **safety** of somatic cell-based therapy in patients experiencing **urinary incontinence** following radical prostatectomy. This assessment is clinically relevant as urinary incontinence significantly impacts the quality of life and daily functioning of affected individuals. Ensuring the safety of new therapeutic approaches is crucial for advancing treatment options and improving patient outcomes in this population.

The clinical trial focuses on **urinary incontinence** and involves a study population exclusively composed of male participants. The age range of the participants falls within categories 3 and 4, which typically correspond to adult and older adult age groups. The trial does not include a vulnerable population, and the selection criteria for the trial population have not been specified by the sponsor. Additionally, the sponsor has not provided information regarding the total number of participants. The study does not specify any particular lifestyle considerations such as diet, physical activity, or habits that may be relevant to the trial. The absence of detailed inclusion or exclusion criteria further limits the available information about the participant selection process.

The clinical trial is designed to evaluate the safety of a **somatic cell-based therapy** for patients experiencing **urinary incontinence** following radical prostatectomy. This is an open-label trial, which means that both the researchers and participants are aware of the treatment being administered. The trial is categorized as a Phase 1 study, focusing primarily on assessing the safety profile of the investigational therapy. The estimated recruitment start date is August 1, 2024, with the trial expected to conclude by May 31, 2026.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, eligibility criteria will be assessed to ensure participants meet the necessary requirements for inclusion in the study. Following successful screening, participants will be enrolled in the trial and will attend scheduled follow-up visits. These visits are designed to monitor the participants' health, assess the safety of the therapy, and collect data on any adverse events or side effects. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall safety outcomes.

The expected duration of participant involvement in the trial will vary depending on individual response and the occurrence of any adverse events. Participants may be subject to early termination from the study if they experience significant adverse reactions, fail to comply with study protocols, or withdraw consent. The trial's design and procedures are structured to ensure the collection of comprehensive safety data while maintaining the well-being of the participants throughout the study period.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included in the trial documentation.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. The information does not include parameters or endpoints used to evaluate efficacy, methods or schedules for measuring, collecting, and analyzing efficacy parameters, or any tools or instruments involved in efficacy assessments. The trial is categorized as Phase 1, with an estimated recruitment start date of August 1, 2024, and an estimated end date of May 31, 2026.