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

This study has been completed.
Sponsor:
Collaborator:
Ockham Development Group
Information provided by (Responsible Party):
Pneumoflex Systems, LLC
ClinicalTrials.gov Identifier:
NCT00801203
First received: December 1, 2008
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Stress Urinary Incontinence
Drug: IRCT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Pneumoflex Systems, LLC:

Primary Outcome Measures:
  • 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 [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]
  • Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI [ Time Frame: Study Day 1 ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801203

Locations
United States, Florida
Clinical Physiology Associates, Inc
Cape Coral, Florida, United States, 33990
MIMA Century Research Associates
Melbourne, Florida, United States, 32901
Winter Park Urology Associates
Orlando, Florida, United States, 32803
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, New York
Accumed Research Associates
Garden City, New York, United States, 11530
University Urology Associates
Manhattan, New York, United States, 10016
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Urology Associates of South Texas
McAllen, Texas, United States, 78503
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Pneumoflex Systems, LLC
Ockham Development Group
Investigators
Study Director: Robert Addington, D.O. Pneumoflex Systems, LLC
  More Information

No publications provided

Responsible Party: Pneumoflex Systems, LLC
ClinicalTrials.gov Identifier: NCT00801203     History of Changes
Other Study ID Numbers: PNEU-01-004
Study First Received: December 1, 2008
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pneumoflex Systems, LLC:
Stress Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014