EUCTR2010-021871-10-CZ进行中（未招募）不适用
A multicenter, randomized, double-blinded, parallel-group, placebocontrolled study to assess the efficacy and safety of skeletal muscle-derived cell implantation in female patients with stress urinary incontinence - Innovation
Innovacell Biotechnologie AG - Life Science Center Innsbruck0 个研究点目标入组 369 人开始时间: 2011年3月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 369
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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 <15 cm H2O,
- •a cystometric capacity >300 mL,
- •compliance of >25 mL/cm H2O,
- •post void residual urine <50 mL,
- •no or low hypermobility of the urethra with Valsalva Q-tip <30°,
- •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, and/or refused pelvic floor muscle training (PFMT),
- •6. Patients who have a negative urine test (dipstick) at Screening,
- •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 the informed consent form prior to any study-related procedures,
- •10. Female patients of childbearing potential willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- •Interim Inclusion Criteria:
- •Patients with an IEF of at least 12 within the last 7 days prior to the visits Visit-1 and Visit 0 (as evaluated from the patient’s micturition diary) and with an I-QoL = 65 as evaluated at Visit-1 and Visit 0 from the I-QoL questionnaire.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 92
排除标准
- •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 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 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).
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