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

May 8, 2012 updated by: Pneumoflex Systems, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Study Day 1
Study Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing
Time Frame: Study Day 1
Study Day 1
Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI
Time Frame: Study Day 1
Study Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pneumoflex Systems, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ockham Development Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Addington, D.O., Pneumoflex Systems, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PNEU-01-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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