Stress Urinary IncontinencePhase 2/3NCT00801203
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
A Phase 2/3 study testing IRCT in people with Stress Urinary Incontinence, run by Pneumoflex Systems, LLC at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- IRCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2008to Jul 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Clinical Physiology Associates, Inc
Cape Coral, Florida, 33990
Accumed Research Associates
Garden City, New York, 11530
University Urology Associates
Manhattan, New York, 10016
Urology Associates of South Texas
McAllen, Texas, 78503
MIMA Century Research Associates
Melbourne, Florida, 32901
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Winter Park Urology Associates
Orlando, Florida, 32803
Urology San Antonio Research
San Antonio, Texas, 78229
Regional Urology, LLC
Shreveport, Louisiana, 71106
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
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
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
- Being tested
- IRCT
- Keywords
- Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRCTDrug
Up to two administrations of the IRCT during a single cough testing session
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Induced Reflex Cough Test (IRCT) followed by Voluntary Cough Test (VCT) Receives: Drug: IRCT |
| 2 | Experimental | Voluntary Cough Test (VCT) followed by Induced Reflex Cough Test (IRCT) Receives: Drug: IRCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study Day 1
Secondary outcomes (2)
Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing
Measured: Study Day 1
Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI
Measured: Study Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneumoflex Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ockham Development Group
- Responsible party
- Sponsor
- Investigators
- Robert Addington, D.O., Study director, Pneumoflex Systems, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801203
- Sponsor's protocol ID
- PNEU-01-004
- Status last verified
- May 2012
- First submitted
- 1 Dec 2008
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00801203
- Acronym / sponsor ID
- PNEU-01-004
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Pneumoflex Systems, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ockham Development Group
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IRCTInduced Reflex Cough Test (IRCT) followed by Voluntary Cough Test (VCT) |
| 2 | Experimental | Drug: IRCTVoluntary Cough Test (VCT) followed by Induced Reflex Cough Test (IRCT) |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRCTUp to two administrations of the IRCT during a single cough testing session | Drug | 1, 2 |
Primary outcome
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
2 secondary outcomes
Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Addington, D.O. study director
Pneumoflex Systems, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IRCT in people with Stress Urinary Incontinence, run by Pneumoflex Systems, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2012.