stress urinary incontinence
Conditions
Interventions
Trade Name: YENTREVE
Product Name: duloxetine
Pharmaceutical Form: Capsule, hard
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 the study. [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
Exclusion criteria
Exclusion criteria: [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 study. [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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effects of duloxetine 40 mg twice daily (BID) in women with urodynamically proved stress urinary incontinence (SUI) on the within-group change in vesical Valsalva leak point pressure (VLPP) from baseline to endpoint (4 weeks). ;Secondary Objective: To evaluate the within-group endpoint/baseline ratios of Root Mean Square Voltage and Mean Rectified Voltage from the rhabdosphincter electromyogram at rest and with coughing, and the ratio of cough/rest ratios from baseline to endpoint (4 weeks). To evaluate the within-group changes in VLPP and ratios of EMG variables from baseline to 6 months and from 4 weeks to 6 months. To describe the percent change in IEF (incontinence episode frequency) from baseline to postbaseline and define two groups, responders and non-responders, based on the threshold value of <50% IEF reduction values. To compare the changes in VLPP and in EMG ratios from baseline to 4 weeks and from baseline to 6 months in responders and non-responders. To evaluate the safety and tolerability of duloxetine 40 mg BID for up to 28 weeks in subjects diagnosed with urodynamic stress incontinence (USI). Safety and tolerability will be evaluated based on TEAEs, discontinuation rates, vital signs, and laboratory analyses.; Primary end point(s): The primary outcome measure will be vesical VLPP. The primary outcome variable will be the change in VLPP from Visit 2 to Visit 3. The primary analysis will be the Wilcoxon signed-rank test on the primary outcome variable. | — |
Countries
Denmark, United Kingdom
Outcome results
None listed