Evaluation of Mesenchymal Stem Cell Therapy in Women Over 50 with Refractory Stress or Mixed Urinary Incontinence

The primary objective of this clinical trial is to evaluate the **feasibility** and **safety** of using mesenchymal stem cells in women over 50 years of age with **stress or mixed urinary incontinence** who have not responded to conventional treatments. This study is clinically relevant as it explores a potential new therapeutic option for a condition that significantly impacts the quality of life and for which current treatments may be inadequate for some patients.

The clinical trial involves a study population of **women** over the age of 50 who are experiencing **stress or mixed urinary incontinence** and have not responded to conventional treatments. The trial exclusively includes female participants, with no male subjects involved. The participants are not considered part of a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population are not specified, and there is no additional information on lifestyle considerations such as diet, physical activity, or habits. The study does not include any male participants, and there is no indication of any specific health status requirements beyond the primary medical condition.

The clinical trial is designed to evaluate the **feasibility** and safety of using mesenchymal stem cells in women over 50 years of age with stress or mixed urinary incontinence who have not responded to conventional treatments. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is December 2, 2024, with an anticipated end date of December 2, 2025, making the overall trial duration approximately one year.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomly assigned to either the treatment or control group. The trial will include multiple follow-up visits to monitor the participants' health, assess the treatment's safety, and evaluate its efficacy. These visits will be scheduled at regular intervals throughout the study period. The end-of-study visit will occur at the conclusion of the trial, where final assessments will be conducted to gather comprehensive data on the primary and secondary endpoints.

The expected length of participant involvement is the entire duration of the trial, approximately one year, unless early termination is warranted. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any other medical or safety concerns as determined by the study investigators. Participants' health and safety will be closely monitored throughout the trial to ensure adherence to ethical standards and regulatory requirements.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a paediatric formulation or if it has orphan drug status. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these non-experimental treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these treatments is also not available in the provided data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 2, 2024, with an estimated completion date of December 2, 2025. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's objective is to evaluate the efficacy of the investigational product, with the results contributing to the understanding of its therapeutic potential.