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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801203
• Other study ID #: PNEU-01-004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 1, 2008
• Last updated: May 8, 2012
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2012
• Source: Pneumoflex Systems, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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 a-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 Design

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

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Physiology Associates, Inc	Cape Coral	Florida
United States	Accumed Research Associates	Garden City	New York
United States	University Urology Associates	Manhattan	New York
United States	Urology Associates of South Texas	McAllen	Texas
United States	MIMA Century Research Associates	Melbourne	Florida
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Winter Park Urology Associates	Orlando	Florida
United States	Urology San Antonio Research	San Antonio	Texas
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Advanced Clinical Research	West Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Pneumoflex Systems, LLC	Ockham Development Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing		Study Day 1	No
Secondary	Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI		Study Day 1	No