A Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence

Study Overview
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Brief Summary
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This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI) in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic testing by evaluation of sensitivity and specificity.

Official Title
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A Phase II/III Controlled Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: IRCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women >25 years of age History of SUI (except for healthy controls) Healthy or stable medical problems (no change in 3 months) Willingness and ability to undergo all the study procedures Stable medications are allowed except for prescription and over-the-counter medications with anticholinergic or α-agonistic properties that can affect the bladder or urethra; these must be discontinued at least 2 weeks prior to evaluation Able to understand and sign the informed consent document. Exclusion Criteria: Body mass index (BMI) >40 History of severe arthritis of the hips, knees, or feet that could limit mobility during the study Prior treatment of any kind (surgical or pharmacologic) for incontinence at least 30 days before the cough testing session including treatment with slings, botox, interstim and all bulking agents Prior pelvic radiation Post-void residual urine >100 mL at screening Pelvic Organ Prolapse Quantification (POP-Q) stage >2 Positive urine culture at screening or dip stick for >1+ leukocyte esterase on the day of the procedures Positive pregnancy test Evidence of infection with hepatitis or human immunodeficiency virus (HIV) Dementia Clinically significant changes on the electrocardiogram (ECG) in women >50 years of age or in the clinical laboratory values as determined by the investigator History of urge symptoms, diagnosis of interstitial cystitis, irritable bowel disease (requiring medications) History of neurological deficit or injury that could affect laryngeal cough reflex, for example, central nervous system related conditions such as stroke or multiple sclerosis, head and neck cancer, major laryngeal surgery History of neurological disorders leading to bladder abnormalities including stroke, Parkinsonism, multiple sclerosis, spinal cord surgery or spinal cord injury Active hemorrhoids or history of recent (within 1 year) rectal surgery Previous major pelvic or abdominal surgery (within 6 months) Tobacco smokers and non-smokers who have >15 pack-year history or frequent (>2 times per week) marijuana smoking Active sexually transmitted disease or genital herpes outbreak or symptomatic pelvic inflammatory disease Pessary in place

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Induced Reflex Cough Test (IRCT) followed by Voluntary Cough Test (VCT) | Drug: IRCT<br>* Up to two administrations of the IRCT during a single cough testing session<br>|
| Experimental: 2<br>Voluntary Cough Test (VCT) followed by Induced Reflex Cough Test (IRCT) | Drug: IRCT<br>* Up to two administrations of the IRCT during a single cough testing session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity to identify SUI in women with a history of SUI and specificity to not identify SUI in healthy women without a history of SUI |  | Study Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing |  | Study Day 1 | 
| Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI |  | Study Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Urinary Incontinence