Stress urinary incontinence (SUI) of moderate severity (Grade 2 and Grade 3) in female patients MedDRA version: 17.1 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
INN or Proposed INN: Skeletal Muscle Derived Cells
Current Sponsor code: SMDC
Other descri
Sponsors
Innovacell Biotechnologie AG - Life Science Center Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients will be eligible for inclusion into the study if all of the following criteria are met: 1. Patients of = 18 years of age 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, 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 92
Exclusion criteria
Exclusion criteria: A patient will not be eligible for inclusion in the study if any of the following criteria are met: 1. Pelvic organ prolapse > Stage I [International Continence Society (ICS) -Classification: the most distal portion of the prolapse is 1 cm or less proximal or distal to the plane of the hymen] 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, 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 during the study, 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, 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 investigator deems concomitant anticoagulant therapy medically acceptable or anticoagulant therapy may be changed to heparin treatment prior to the study 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 suffering from major depressive disorders, and/or generalized anxiety disorders, 17. Patients with a history of: duloxetine treatment within a period of 6 months prior to patient inclusion, 18. Patients with severe myocardial disorders or irregular pulse, and those with an artificial pacemaker, 19. Patients depending on 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 clinically relevant increase in C-reactive protein (CRP) (i.e. > 35 mg/mL) and confirmed by bacteriological analysis, 22. Patients with known hypersensitivity to any component of the product (autologous cells, ringer’s lactate, human serum albumin, dimethylsulfoxid (DMSO), bovine serum albumin, fibroblast growth factor). Interim Exclusion Criterion: Patients with diarrhea at time of procurement (Visit -1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to show superiority of skeletal muscle-derived cells (SMDCs) over placebo in female patients with SUI;Secondary Objective: no secondary objectives;Primary end point(s): 1. Responder rate; response is defined as a reduction in the IEF of 75% from baseline (Visit 0) to Visit 4. The IEF is calculated as number of incontinence episodes that occurred during 7 days preceding a visit. 2. Change from baseline (Visit 0) to Visit 4 of the SUI complaints measured by the I-QoL sum score.;Timepoint(s) of evaluation of this end point: V-1 V0 V2 V3 V4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy variables • Frequency of responders regarding the IEF score; different definitions of response (reduction by 50% and 90%) will be used, • Change from baseline (Visit 0) in the I-QoL subscale scores, • Change from baseline (Visit 0) in the IEF score, • Change from screening in the short pad-test results, • Change from baseline (Visit 0) in the VAS score, • Investigator’s assessment by the Clinical Global Impression (CGI) score. Standard safety examinations like comparison of routine laboratory measures and frequency, type, intensity, and seriousness of adverse events (AEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) will be provided.;Timepoint(s) of evaluation of this end point: • Change from baseline in the IEF score: V-1, V0, V2, V3, V4, V5, V6 • Change from baseline (Visit 0) in the I-QoL subscale scores: V-1, V0, V2, V3, V4, V5, V6 • Change from screening in the short pad-test results: Screening, V2, V3, V4, V5, V6 • Change from baseline (Visit 0) in the VAS score: V-1, V0, V2, V3, V4, V5, V6 • Investigator’s assessment by the Clinical Global Impression (CGI) score: Screening, V3, V4, V5, V6 • Standard safety examinations: Screening, V0, V1, V1a, V2, V3, V4, V5, V6 | — |
Countries
Austria, Bulgaria, Czech Republic, France, Germany, Italy, Netherlands, Romania, Slovenia, Spain, Switzerland, United Kingdom
Contacts
Public ContactReferat Klinische Prüfungen
Paul-Ehrlich-Institut
Outcome results
None listed