Stress Urinary IncontinenceNCT02742584
Standardization of Cough Stress Test
A study testing Cough Stress Test in people with Stress Urinary Incontinence, run by University Hospitals Cleveland Medical Center.
Trial summary
This is a multicenter, prospective, randomized comparative study in which patients are randomized to one of four different bladder volumes and a Cough Stress Test (CST) is performed in both the standing and sitting positions. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Cough Stress Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Mar 2015
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- symptoms of urinary incontinence as a chief complaint or as the reason for scheduling the clinic visit, and who were to be scheduled to undergo urodynamic (UDS) testing after initial evaluation by their physician
Who cannot join
- pelvic organ prolapse beyond stage 1 Pelvic Organ Prolapse- Quantification (POP-Q) as diagnosed by the examining physician
- any other clinical diagnosis other than urinary incontinence who undergo UDS testing ( e.g. interstitial cystitis, overactive bladder dry, bladder outlet obstruction)
- were taking alpha agonists or anticholinergic medications within 2 weeks of the testing
- had an elevated Post Void Residual (PVR) >50cc
- any physical or mental disability that would either not allow participation or impede the ability to give fully informed consent
- pregnancy
About this study
Official title: A Randomized Comparative Study Correlating Cough Stress Test With Urodynamics And 24 Hour Pad Test In the Evaluation of Stress Urinary Incontinence
This is a multicenter, prospective, randomized comparative study in which patients are randomized to one of four different bladder volumes and a Cough Stress Test (CST) is performed in both the standing and sitting positions. The goal is to assess the agreement of each CST method with both urodynamics diagnosis of Stress Urinary Incontinence (SUI) and the 24-hour pad test. The primary outcome is to determine what CST method best correlated with either test in the diagnosis of SUI.
Read the detailed description
This multicenter, prospective randomized study is approved by the Institutional Review Boards at both the University Hospitals Case Medical Center, Cleveland, OH, USA and MetroHealth Hospital, Cleveland, OH, USA (Identifiers 07-11-37 and FWA00003938, respectively). Adult women who presented to the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) outpatient clinics at both the University Hospitals Case Medical Center and MetroHealth Hospital with symptoms of stress, urge, or mixed urinary incontinence and who were recommended by the evaluating staff to undergo urodynamic studies (UDS) are eligible. The staff physician will approach the patient for participation in this study after the standard clinic visit is completed and the initial diagnosis is made. A research coordinator will then explain the study and obtain informed consent if the patient agrees to participate. The patient will then be given instructions for a 24 hour pad test and standardized pads to use. The patient will also be given instructions for a three day voiding diary along with routine instruction regarding the urodynamic procedure. The patient will be asked to perform the 24 hour pad test the day prior to the UDS appointment. The three day voiding diary will be performed during a typical and sequential three day period during the week prior to the UDS. Patients will then asked to bring these items to the UDS appointment.
During the initial appointment with the study coordinator, patients will be randomized to 4 groups (A, B, C, and D). Patients in group A will be scheduled to undergo Cough Stress Test (CST) with a comfortably full bladder. This will be subjectively reported by the patient. Patients in group B will be scheduled to undergo CST with an empty bladder after straight catheterization. Group C patients will be scheduled to undergo CST with a bladder infused with 200 cc of saline. Patients in group D will be scheduled to undergo CST with the bladder filled to half functional capacity as determined from the largest voided volume recorded in the patient's voiding diary. CST will be performed in the standing and sitting position for each patient in each of the above groups. The sequence of performing the standing and sitting CST will be randomly assigned for each patient.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Cough Stress Test
- Keywords
- cough stress test, urodynamics, pad test
- 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.
Cough Stress TestProcedure or surgery
Varying bladder volumes during cough stress test.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Cough Stress Test with a comfortably full bladder. Receives: Procedure: Cough Stress Test |
| Group B | Experimental | Cough Stress Test with an empty bladder after straight catheterization. Receives: Procedure: Cough Stress Test |
| Group C | Experimental | Cough Stress Test with a bladder infused with 200 cc of saline. Receives: Procedure: Cough Stress Test |
| Group D | Experimental | Cough Stress Test with the bladder filled to half functional capacity as determined from the largest voided volume recorded in the patient's voiding diary. Receives: Procedure: Cough Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of cough stress test with urodynamics
To define how different accepted cough stress test methods correlated with urodynamics in the evaluation of stress urinary incontinence.
Measured: 30 minutes
Secondary outcomes (1)
24hour pad weight
To assess if there was any benefit to performing a 24 hour pad test with or without the different cough stress test modalities.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startAug 2012
- Primary completionMar 2015
- Study completionMar 2015
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.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Henderson, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742584
- Sponsor's protocol ID
- 07-11-37
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study Correlating Cough Stress Test With Urodynamics And 24 Hour Pad Test In the Evaluation of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02742584
- Acronym / sponsor ID
- 07-11-37
- Conditions
- Stress Urinary Incontinence
- Keywords
- cough stress test, urodynamics, pad test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Apr 2016 (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 is a multicenter, prospective, randomized comparative study in which patients are randomized to one of four different bladder volumes and a Cough Stress Test (CST) is performed in both the standing and sitting positions. The goal is to assess the agreement of each CST method with both urodynamics diagnosis of Stress Urinary Incontinence (SUI) and the 24-hour pad test. The primary outcome is to determine what CST method best correlated with either test in the diagnosis of SUI.
Detailed description
This multicenter, prospective randomized study is approved by the Institutional Review Boards at both the University Hospitals Case Medical Center, Cleveland, OH, USA and MetroHealth Hospital, Cleveland, OH, USA (Identifiers 07-11-37 and FWA00003938, respectively). Adult women who presented to the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) outpatient clinics at both the University Hospitals Case Medical Center and MetroHealth Hospital with symptoms of stress, urge, or mixed urinary incontinence and who were recommended by the evaluating staff to undergo urodynamic studies (UDS) are eligible. The staff physician will approach the patient for participation in this study after the standard clinic visit is completed and the initial diagnosis is made. A research coordinator will then explain the study and obtain informed consent if the patient agrees to participate. The patient will then be given instructions for a 24 hour pad test and standardized pads to use. The patient will also be given instructions for a three day voiding diary along with routine instruction regarding the urodynamic procedure. The patient will be asked to perform the 24 hour pad test the day prior to the UDS appointment. The three day voiding diary will be performed during a typical and sequential three day period during the week prior to the UDS. Patients will then asked to bring these items to the UDS appointment.
During the initial appointment with the study coordinator, patients will be randomized to 4 groups (A, B, C, and D). Patients in group A will be scheduled to undergo Cough Stress Test (CST) with a comfortably full bladder. This will be subjectively reported by the patient. Patients in group B will be scheduled to undergo CST with an empty bladder after straight catheterization. Group C patients will be scheduled to undergo CST with a bladder infused with 200 cc of saline. Patients in group D will be scheduled to undergo CST with the bladder filled to half functional capacity as determined from the largest voided volume recorded in the patient's voiding diary. CST will be performed in the standing and sitting position for each patient in each of the above groups. The sequence of performing the standing and sitting CST will be randomly assigned for each patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Cough Stress TestCough Stress Test with a comfortably full bladder. |
| Group B | Experimental | Procedure: Cough Stress TestCough Stress Test with an empty bladder after straight catheterization. |
| Group C | Experimental | Procedure: Cough Stress TestCough Stress Test with a bladder infused with 200 cc of saline. |
| Group D | Experimental | Procedure: Cough Stress TestCough Stress Test with the bladder filled to half functional capacity as determined from the largest voided volume recorded in the patient's voiding diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptoms of urinary incontinence as a chief complaint or as the reason for scheduling the clinic visit, and who were to be scheduled to undergo urodynamic (UDS) testing after initial evaluation by their physician
Key exclusion criteria (6 listed)
- pelvic organ prolapse beyond stage 1 Pelvic Organ Prolapse- Quantification (POP-Q) as diagnosed by the examining physician
- any other clinical diagnosis other than urinary incontinence who undergo UDS testing ( e.g. interstitial cystitis, overactive bladder dry, bladder outlet obstruction)
- were taking alpha agonists or anticholinergic medications within 2 weeks of the testing
- had an elevated Post Void Residual (PVR) >50cc
- any physical or mental disability that would either not allow participation or impede the ability to give fully informed consent
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 |
|---|---|---|
| Cough Stress TestVarying bladder volumes during cough stress test. | Procedure or surgery | Group A, Group B, Group C, Group D |
Primary outcome
Correlation of cough stress test with urodynamics
Time frame: 30 minutes
To define how different accepted cough stress test methods correlated with urodynamics in the evaluation of stress urinary incontinence.
1 secondary outcome
24hour pad weight
Time frame: 24 hours
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 21 Apr 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cough Stress Test in people with Stress Urinary Incontinence, run by University Hospitals Cleveland Medical Center.
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 1 inclusion and 6 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 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Correlation of cough stress test with urodynamics (time frame: 30 minutes). 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 21 Apr 2016.