EUCTR2004-004160-67-GB进行中（未招募）1 期
Effect of Duloxetine on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography Measures in Women with Stress Urinary Incontinence
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Subjects may be included in the study only if they meet all of the following criteria:
- •[1] Are female outpatients.
- •[2] Are =18 and =75 years of age.
- •[3] Have a diagnosis of only stress urinary incontinence (SUI)
- •(urodynamic stress incontinence [USI] with normal compliance and no
- •detrusor overactivity [DO]) confirmed on urodynamic studies (UDS)
- •(determined at Visit 2; see Section 3.2.2.1) and a positive Valsalva
- •leak point pressure (VLPP).
- •[4] Have discrete episodes of incontinence (that is, are dry between
- •episodes and not continuously leaking urine), synchronous with
- •increased abdominal pressure from coughing, sneezing, exercising,
- •etc. An episode is defined as an easily noticeable leakage of urine that
- •would wet a pad, containment garment, or article of clothing.
- •[5] Are ambulatory and able to use a toilet independently and without
- •difficulty.
- •[6] Have no language or cognitive barriers, agree to comply with the
- •requirements of the protocol, and sign a written informed consent
- •document (ICD) prior to entry into the study.
- •[7] Are women of non-childbearing potential by reason of hysterectomy,
- •other surgery, or natural menopause, or are women of childbearing
- •potential agreeing to use a medically accepted means of contraception
- •(for example, intrauterine device [IUD], oral or injectable
- •contraceptives, implant, barrier device, sterilization, abstinence, or sex
- •with a vasectomized male partner) for the duration of the study.
- •Women using oral contraceptives or hormone replacement therapy
- •must have a stable dose and regimen for =3 months prior to entry into
- •[8] Have no pelvic organ prolapse protruding more than 1 cm beyond the
- •hymen (Bump et al. 1996).
- •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
- •[9] At Visit 1, have a positive urine culture (>100,000 cfu/mL), or a history of four or more urinary tract infections in the preceding year.
- •[10] Have spinal cord lesions, multiple sclerosis, or other major central
- •nervous system (CNS) abnormalities that affect the lower urinary tract.
- •[11] Suffer from severe constipation (have a history of fecal impaction or
- •have impacted rectum at time of physical examination despite recent
- •evacuation).
- •[12] 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
- •randomization, or is anticipated to change during the course of the
- •[13] Have had urethral surgery (for example, diverticulectomy, urethral
- •dilations, or bulk injections).
- •[14] Have had more than one continence surgery.
- •[15] Have had any major surgery or continence surgery within 6 months
- •prior to study entry.
- •[16] Have 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. Adult enuresis or voiding difficulty.
- •[17] Use any of the following currently or at any time during the study:
- •a. Any anti-incontinence device including tampons used to prevent incontinence
- •b. Any medication in the list of excluded medications
- •[18] Have used any pharmacologic (including duloxetine for any reason) or
- •nonpharmacologic (such as electrostimulation, vaginal cones, or any
- •device) intervention for incontinence or prolapse within 3 months prior
- •to study entry or throughout the study.
- •[19] Began pelvic floor muscle exercises within 6 months prior to study entry. Subjects who regularly perform pelvic floor muscle exercises cannot change their
- •exercise regimen during the course of the study.
- •[20] Have current or past urogenital cancer.
- •[21] Have any condition, limitation, disease, or abnormal laboratory value
- •that could, in the judgment of the investigator, preclude evaluation of
- •response to duloxetine.
- •[22] On physical examination, have neurological and/or vaginal
- •examination results that, in the opinion of the investigator, should
- •exclude the subject.
- •[23] Are known to have increased intraocular pressure or to be at risk for
- •acute narrow-angle glaucoma.
- •[24] Have a symptomatic arrhythmia despite antiarrhythmic medication.
- •[25] Have current angina or any active cardiac ischemic condition,
- •including myocardial infarction, within 6 months prior to study entry.
- •[26] Have uncontrolled or poorly controlled hypertension.
- •[27] Have active seizure disorder.
- •[28] Have unstable diabetes mellitus.
- •[29] Have a known hypersensitivity to duloxetine or any of the inactive
- •ingredients.
- •[30] Have a history of severe
研究者
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