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

NCT00801203 | Completed Phase 2

• 1 other identifier: PNEU-01-004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 10

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Induced Reflex Cough Test (IRCT) followed by Voluntary Cough Test (VCT)

Drug: IRCT

2

EXPERIMENTAL

Voluntary Cough Test (VCT) followed by Induced Reflex Cough Test (IRCT)

Drug: IRCT

Interventions

IRCT DRUG

Up to two administrations of the IRCT during a single cough testing session

1; 2

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pneumoflex Systems, LLC: lead
• Ockham Development Group: collaborator

Study Sites (10)

Clinical Physiology Associates, Inc

Cape Coral, Florida, 33990, United States

Location

MIMA Century Research Associates

Melbourne, Florida, 32901, United States

Location

Winter Park Urology Associates

Orlando, Florida, 32803, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

University Urology Associates

Manhattan, New York, 10016, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates of South Texas

McAllen, Texas, 78503, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Addington, D.O.

  Pneumoflex Systems, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

US (10)