Stress urinary incontinence (SUI) in female patients with predominantly intrinsic sphincter deficiency of moderate severity (Grade 2 and Grade 3) MedDRA version: 14.0 Level: PT Classification code 10066218 Term: Stress urinary incontinence System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Skeletal Muscle Derived Cells
Product Code: SMDC
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Skeletal Muscle Derived Cells (SMDC)
Concentration unit: Other
Concen
Sponsors
Innovacell Biotechnologie AG - Life Science Center Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of =18 to 75 years, 2. Graded as moderate SUI at the 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 urodynamic testing (filling cystometry, urethral pressure profile) at screening. Patients will only be included in case of: - missing detrusor overactivity, i.e. involuntary detrusor contraction, - a cystometric capacity >300 mL, - compliance of >25 mL/cm H2O, - post void residual urine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pelvic organ prolapse >Stage II (ICS-Classification: The most distal portion of the prolapse is more than 1 cm below the plane of the hymen, but protrudes no further than two centimeters less than the total vaginal length in cm) detected during the last 12 months prior to patient inclusion in the study, 2. Patients who have a medical history of uncontrolled overactive bladder (OAB) or urinary incontinence other than SUI (including anamnestic complaints on involuntary urine leakage accompanied by or immediately preceded by urgency, not stress induced), 3. Patients who have undergone a surgery in pelvis minor due to cancer, 4. Patients who have undergone any surgery for SUI, including midurethral slings, Burch colposuspension, or bulking agents, 5. Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute viral hepatitis HBV, and/or active Syphilis, 6. Patients diagnosed with any kind of skeletal muscle disease, 7. Patients who, according to the clinical judgment of the investigator, are not suitable for this study, 8. Patients who are currently participating or have participated in another clinical trial (testing medical device or drug) within 30 days prior to the study begin or have previously participated in the current clinical study, 9. Patients who are pregnant, lactating, or intending pregnancy in the near future, and those of childbearing potential who are not willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence), 10. Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain, 11. Patients with compromised immune systems, 12. Patients complaining about symptoms of acute cystitis or urethritis at visit 0, 13. Patients who had previously undergone radiation of the pelvis, 14. Patients with coagulopathy and/or currently being under treatment with anticoagulant drugs. However, if the anticoagulant therapy may be changed to heparin treatment prior to the therapy, the patients can be included into the study, 15. Patients with chronic pelvic pain or complaining about pelvic pain syndrome and/or dyspareunia, 16. Patients with uncontrolled narrow-angle glaucoma, 17. Patients with severe myocardial disorders or irregular pulse, and those with an artificial pacemaker, 18. Patients with implantations of metal components in the electrical stimulation treatment area, 19. Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.), 20. Patients with a malignant disease not in remission for 5 years or more, 21. Patients with any persistent chronic bacterial infections as well as local infections as indicated by a high value of CRP and confirmed by bacteriological analysis, 22. Patients with known hypersensitivity to any component of the product (autologous cells, ringer’s lactate, human serum albumin, DMSO, bovine proteins, fibroblast growth factor).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the functional status of the urethra and particularly the urethral rhabdosphincter by means of urodynamic measures after SMDCs implantation procedure in female patients with SUI.;Secondary Objective: Efficacy variables: - Change from baseline of maximum urethral closure pressure, - Change from baseline of the functional urethral length, - Change from baseline of the area under the curve (AUC) of the urethral pressure curve at rest, - Change from baseline of the IEF score (a response is defined as a reduction by 50% and 75%), - Change from baseline in the Visual Analogue Scale (VAS) score, - Change from baseline in the short pad-test results, - Change from baseline in the I-QoL score, - Examinations based on the micturition diary records, - Investigator’s Assessment by the Clinical Global Impression (CGI) score. Safety variables: - Physical examination, - Safety laboratory tests, - AEs.;Primary end point(s): The primary endpoint of the current study is the change from baseline in the USP measured by the transmission ratio in percent in the midurethra. | — |
Countries
Slovenia
Outcome results
None listed