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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: IRCT

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Coral, Florida, United States, 33990
      • Clinical Physiology Associates, Inc
    • Melbourne, Florida, United States, 32901
      • MIMA Century Research Associates
    • Orlando, Florida, United States, 32803
      • Winter Park Urology Associates
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
    • Manhattan, New York, United States, 10016
      • University Urology Associates
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • McAllen, Texas, United States, 78503
      • Urology Associates of South Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Utah
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pneumoflex Systems, LLC
• Collaborators: Ockham Development Group
• Investigators: Study Director: Robert Addington, D.O., Pneumoflex Systems, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: December 1, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: PNEU-01-004