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

Pneumoflex Systems

Status and phase

Completed

Phase 3

Phase 2

Conditions

Stress Urinary Incontinence

Treatments

Drug: IRCT

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00801203

PNEU-01-004

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

Female

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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