Stress Urinary Incontinence Study to assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
Target group
Women between the ages of 20 and 65 who suffer from stress-related urinary leakage.Aim of the study
The aim of the SUISSE MPC2 study is to treat stress urinary incontinence (SUI) in women between the ages of 20 and 65 using the body's own muscle progenitor cells.
The muscle precursor cells are harvested from the calf muscles in the smallest possible surgical procedure under local anesthesia. After preparation in the laboratory under clean room conditions, they are inserted into the bladder sphincter via the urethra using a syringe.
Patients will participate in the study over a period of approximately 8 to 9 months, including an examination at the beginning of the study, an examination to take a muscle biopsy, an injection of the muscle progenitor cells up to 5 weeks after the biopsy collection and follow-up examinations at 1, 3 and 6 months after the injection.
At the beginning and end of the study, a pelvic MRI (magnetic resonance imaging) examination is also carried out at the Department of Radiology, as well as a urodynamic examination (examination of the urinary tract and bladder) by neuro-urologists.
In addition, an appointment at the IFA consultation is necessary before the injection.
All study-specific visits and appointments take place at the USZ Campus or USZ Circle (depending on the situation).
During the course of the study, questionnaires, 3-day bladder diaries and 24-hour insertion tests must be completed at regular intervals.
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