Autologous skeletal muscle-derived cell implantation in female patients with stress urinary incontinence a mutliceter, randomized, parallel-group, placebo-controlled clinical study SUITE study

Inclusion criteria: Female patients will be eligible for inclusion into the study if all of the following criteria are met:
1. Patients at the age of 18-75,
2. Graded as moderate SUI at screening visit, according to the classification based on the short-pad test of Hahn and Fall (1991): Grade 2 (2-10 ml leakage) or Grade 3 (11-50 ml leakage),
3. Diagnosed with SUI, predominantly intrinsic sphincter deficiency, confirmed by ambulatory urodynamic testing (filling cystometry) at screening. Patients will be included only in case of:
    - missing detrusor overactivity, i.e. involuntary detrusor contraction with a pressure <15 cm H2O,
    - a cystometric capacity >300 ml,
    - compliance of >25 ml/cm H2O,
    - post void residual urine <50 ml,
    - ability to void urine spontaneously.
4. The SUI diagnosis has to be based on the patient’s medical history (including anamnestic complaints of involuntary leakage on effort or exertion or on sneezing or coughing) and a positive cough test (fixed volume) at the screening visit,
5. History of inefficient, insufficient, or refused pelvic floor muscle training (PFMT),
6. Patients who have a negative urine test (dipstick) at visit 0,
7. Patients willing and able to comply with the study procedures,
8. Patients who are mentally competent and able to understand all study requirements,
9. Patients must agree to read and sign informed consent form prior to any study related procedures.