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

Sponsor

Pneumoflex Systems, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00801203

Collaborator

Ockham Development Group (Other)

180

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: IRCT	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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

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

Outcome Measures

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 [Study Day 1]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Physiology Associates, Inc	Cape Coral	Florida	United States	33990
2	MIMA Century Research Associates	Melbourne	Florida	United States	32901
3	Winter Park Urology Associates	Orlando	Florida	United States	32803
4	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
5	Accumed Research Associates	Garden City	New York	United States	11530
6	University Urology Associates	Manhattan	New York	United States	10016
7	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
8	Urology Associates of South Texas	McAllen	Texas	United States	78503
9	Urology San Antonio Research	San Antonio	Texas	United States	78229
10	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pneumoflex Systems, LLC

ClinicalTrials.gov Identifier:

NCT00801203

Other Study ID Numbers:

PNEU-01-004

First Posted:

Dec 3, 2008

Last Update Posted:

May 9, 2012

Last Verified:

May 1, 2012

Keywords provided by Pneumoflex Systems, LLC

Stress Urinary Incontinence

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of May 9, 2012