Stress urinary incontinence (SUI) in female patients with predominately intrinsic sphincter deficiency of moderate severity MedDRA version: 9.1 Level: LLT Classification code 10066218 Term: Stress urinary incontinence
Conditions
Interventions
Product Name: Skeletal muscle-derived cells
Product Code: SMDCs
Pharmaceutical Form: Suspension for injection
Product Name: Skeletal muscle-derived cells
Product Code: SMDCs
Pharmaceutical Form: Su
Sponsors
Innovacell Biotechnologie AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of = 18 years of age, • Age limit approved for Germany: 18 – 75 years, • Age limit approved for the Czech Republic: 18 – 65 years. 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 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 [Ref a)1], 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, i.e. midurethral slings, 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 (only valid for patients in cell implantation groups), 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 suffering from major depressive disorders, and/or generalized anxiety disorders, 17. Patients treated with monoamine oxidase inhibitors (MAOIs) and/or sedatives, serotonergic drugs (including triptans), alpha(1)-adrenoreceptor antagonists, 18. Patients with a history of: duloxetine treatment within a period of 6 months prior to patient inclusion, liver disease resulting in hepatic impairment, uncontrolled hypertension, severe renal impairment, hypersensitivity to hydrochloride, and/or treatment with CYP1A2 inhibitors as fluvoxamine, ciprofloxacin, or enoxacine, and/or CYP3A4 inducers such as St. John’s wort, 19. Patients with uncontrolled narrow-angle glaucoma, 20. Patients with severe myocardial disorders or irregular pulse, and those with an artificial pacemaker, 21. Patients with implantations of metal components in the electrical stimulation treatment area, 22. Patients dependent from the sponsor, CRO, or the investigator (e.g. employees, relatives, etc.), 23. Patients with malignant disease not in remission for five years or more, 24. Patients with a specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to find the optimal cell count for functional regeneration of the urethral sphincter, including safety evaluation. ;Primary end point(s): Change from baseline (visit -5) of the Incontinence Episode Frequency (IEF) score. The IEF is calculated as number of incontinence episodes that occurred during 7 days receding a visit.;Secondary Objective: Efficacy variables: • Change from baseline in the IEF score for comparison of each pair wise combination of treatment groups not considered in the primary analysis, • Change from screening in the short pad-test results, • Change from baseline in the I-QoL score, • Change from baseline in the Visual Analog Scale (VAS) score, • Frequency of responders regarding the IEF score; different definitions of response (reduction by 50% and 75%) will be used, • Amount of urinary volume lost during incontinence episodes, • Correlation between fluids taken and IEF score, • Investigator’s assessment by Clinical Global Impression (CGI) score. Standard safety examinations like comparison of routine laboratory measures and frequency, type, intensity, and seriousness of AEs including Suspected Unexpected Serious Adverse Reactions (SUSARs) will be provided. | — |
Countries
Bulgaria, Czech Republic, Germany
Outcome results
None listed