Clinical trial NCT00801203: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
Lead sponsor: Pneumoflex Systems, LLC
Sponsor class: INDUSTRY
Collaborators: name: Ockham Development Group
First posted: 2008-12-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Study Day 1
Secondary outcomes:
measure: Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing
timeFrame: Study Day 1
measure: Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI
timeFrame: Study Day 1
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: Clinical Physiology Associates, Inc
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: Manhattan
country: United States
facility: University Urology Associates
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: McAllen
country: United States
facility: Urology Associates of South Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Pneumoflex Systems, LLC
name: Robert Addington, D.O.
role: STUDY_DIRECTOR
References: