EUCTR2005-001021-28-SE进行中（未招募）不适用
.A double-blind, stratified, randomised, parallel, placebo-controlled, multi-centre study to assess the efficacy and safety of duloxetine (20 mg bid for 2 weeks escalating to 40 mg bid) for up to 12 weeks, compared to placebo, in community-dwelling elderly women = 65 years of age with symptoms of stress urinary incontinence or stress–predominant mixed urinary incontinence. - Active elderly
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 276
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
- •1. Is a female outpatient >65 years of age.
- •2. Have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months prior to visit 1.
- •3. Have at least 7 incontinence episodes per week as determined by the S/UIQ at Visit 1. For subjects with MUI, at least 50% of the IEF must be due to stress recorded on the S/UIQ at Visit 1 (see section 11.1).
- •4. Fit the definition of community dwelling women. A community dwelling subject is defined as a subject sufficiently autonomous to live in society at large on her own.
- •5. Is ambulatory and able to use a toilet independently and without difficulty.
- •6. Have a post void residual (PVR) volume of <100 mL identified either by catheterisation or a bladder scan within 15 minutes of a spontaneous void.
- •7. Have no language or significant cognitive barriers (as determined by the Modified Mini-Mental State Exam 3MS score of >80), agree to comply with the requirements of the protocol and has signed a written informed consent document prior to any study procedures.
- •8. Have responded appropriately to all screening questions at visit 1.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. At Visit 1 have a positive urine culture (>100,000 cfu/mL) or a history of four or more (>4) urinary tract infections (UTIs) in the preceding year.
- •2. Suffer from severe constipation (for example have impacted rectum at time of physical examination) at study entry.
- •3. Are on a regimen of a chronically administered medication where dose and/or frequency has not been stable for at least 3 months prior to study entry or is anticipated to change during the course of the study.
- •4. Have had continence surgery or received bladder neck bulking agent therapy, including collagen injections for incontinence, within 3 months prior to study entry.
- •5.Have pelvic organ prolapse greater than stage II (>2); that is, protrusion of any vaginal segment greater than 1 cm (>1 cm) beyond the hymen at study entry.
- •6. Have had any major surgery within 3 months prior to study entry.
- •7. Have a current diagnosis of any of the following conditions, disorders or diseases of the genitourinary tract:
- •a) Ureteric, bladder, urethral or rectal fistula
- •b) Uncorrected congenital abnormality leading to urinary incontinence
- •c) Voiding difficulty including significant hesitancy or history of retention
- •8. Have had any non-pharmacologic intervention for incontinence or prolapse (for example, electrostimulation, vaginal cones, pessaries, tampons, bladder training) within 3 months prior to study entry or throughout the study.
- •9. Began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study. Subjects who regularly perform pelvic floor muscle exercises cannot change their exercise regimen during the course of the study.
- •10. Have neurologic lesions or conditions (for example, multiple sclerosis, spinal cord lesions or Parkinson’s disease) or local lesions (for example, bladder stones present or tumors) that affect the lower urinary tract.
- •11. Have any condition, limitation, disease or abnormal laboratory value that could, in the judgment of the investigator, preclude evaluation of response to duloxetine.
- •12. Are judged prior to randomisation (visit 1, 2, 3) to be at suicidal risk, identified as a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II) (see section 11.3).
- •13. Have any active substance abuse disorders within the 5 years prior to study entry.
- •14. Have a history of mania or bipolar disorder.
- •15. Have active seizure disorder.
- •16. Have a symptomatic arrhythmia despite antiarrhythmic medication, uncontrolled angina or a significant abnormality on ECG within the six months prior to randomisation, that in the opinion of the investigator, requires investigation or intervention
- •17. Are prone to syncopal episodes
- •18. Have any active cardiac ischaemic condition, including myocardial infarction, within 6 months prior to randomisation
- •19. Have hepatic dysfunction .by the following laboratory parameters:
- •SGPT (ALT) or SGOT (AST) > 3 times upper limit of normal (ULN), or
- •Bilirubin> 1.5 times ULN.
- •20. Have known severe renal impairment as defined by creatinine clearance <30 mL/min.
- •21. Intake of monoamine oxidase inhibitors (MAOIs) or any other excluded medication within 14 days prior to randomisation or at any time during the study.
- •22 Have current urogenital cancer.
- •23. Have abnormal thyroid-stimulating hormone (TSH) concentration.
- •24. Have uncontrolled narrow-angle glaucoma.
- •25. Have a history of severe allergies, including drug allergies, requiring emergency medical tre
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