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

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

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.

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