- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05809154
Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success (UroLUTS)
Prospective Cohort Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients with a clinical indication for routine urodynamic assessment will be included in to this prospective cohort study. All standard urodynamic results as well as the treatment decision will be collected. Patients undergoing repeated urodynamic measurements i.e. spinal cord injured patients with yearly assessments will each time be included allowing for long-term and follow up analysis of both disease progress and therapy success.
Bladder function is rather simple: storage and voiding of urine. The control of the urinary bladder on the other hand is very complex with many areas that still remain unclear, as for example the cross play of the central and and autonomous nervous system. Voiding of the bladder is an active process that is controlled by nervous impulses from the central nervous system. The detrusor muscle is contracted, and the urethral sphincter muscle is relaxed at the same time so that the urine can be drained off.
Uroflow examination in combination with post-void residual assessment (by sonography or catheterization) are a simple but powerful screening tool to evaluate bladder function. Since both the uroflow as well as the post-void residual are dependent on the detrusor pressure and the infravesical resistance they do not allow for differentiation between hypocontractile detrusor muscle and infravesical obstruction or a combination of both. To do so, the minimal invasive Urodynamic examination is needed. Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase. By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system. The pelvic floor muscle activity (i.e. the urethral sphincter muscle) is assessed at the same time using EMG surface electrodes.
For Video-Urodynamics, Contrast agent is mixed in to the body warm infusion solution allowing to judge bladder configuration (i.e. diverticula or trabeculation) and if there is vesico-uretero-renal reflux.
Patients with a clinical indication for routine urodynamic assessment will be included in to this prospective cohort study. All standard urodynamic results as well as the treatment decision will be collected. Patients undergoing repeated urodynamic measurements i.e. spinal cord injured patients with yearly assessments will each time be included allowing for long-term and follow up analysis of both disease progress and therapy success.
Except for urinary tract infections, are complications in urodynamic measurements very rare. The investigators estimate additional complications (like pain or autonomic dysreflexia) in about 1% of urodynamic examinations. To have a minimum of 50 complications, the investigators aim to include about 5000 urodynamic examinations for reliable numbers of each complication, ideally allowing for subgroup analysis.
All patients undergoing clinical routine urodynamic examination will be included, i.e. per year approximately 500 urodynamic measurements and 450 patients (some patients will have multiple measurements per year). With the aim of 5000 included urodynamic examinations the investigators estimate a study duration of 10 years. This has the advantage that the investigators will also have a meaningful average follow-up of at least 5 years or more in patients undergoing annual urodynamic measurements (e.g. spinal cord injured patients).
Descriptive statistics: Data will be presented on interval-scales with median and quartiles or with means and standard deviations summarized. Dichotomic variables will be presented as ratios and percentages.
Univariate analysis: t-test will be used to compare means between groups and Chi-Square for the comparison of dichotomic variables.
Multivariate analysis: To assess the distribution of initial parameters the investigators will use multivariate regression models.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Female and male patients, age >18 years
- Informed consent
- Lower urinary tract symptoms
- Planned clinical routine urodynamic examination
Exclusion Criteria:
The presence of any of the following exclusion criteria will lead to exclusion of the participant:
- Age <18 years
- Pregnancy or breast feeding
- Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences https://www.samw.ch/en/Publications/Medical-ethical-Guidelines.html)
- No informed consent
- Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neurogenic lower urinary tract dysfunction
Lower urinary tract dysfunction due to any neurological condition like spinal cord injury, multiple sclerosis and others.
|
Minimal invasive Urodynamic examination: Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase.
By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system.
The pelvic floor muscle activity is assessed at the same time using EMG surface electrodes.
|
Non-Neurogenic lower urinary tract dysfunction
Lower urinary tract dysfunction in absence of any neurological pathology.
|
Minimal invasive Urodynamic examination: Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase.
By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system.
The pelvic floor muscle activity is assessed at the same time using EMG surface electrodes.
|
Chronic pelvic pain
Chronic pelvic pain as defined by the EAU guidelines.
|
Minimal invasive Urodynamic examination: Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase.
By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system.
The pelvic floor muscle activity is assessed at the same time using EMG surface electrodes.
|
Urodynamic normal Bladder function
Normal urodynamic findings and absence of chronic pelvic pain.
|
Minimal invasive Urodynamic examination: Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase.
By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system.
The pelvic floor muscle activity is assessed at the same time using EMG surface electrodes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of voids per 24 hours
Time Frame: At the urodynamic assessment, up to 24 hours
|
Number of voids per 24 hours
|
At the urodynamic assessment, up to 24 hours
|
Number of leakages per 24 hours
Time Frame: At the urodynamic assessment, up to 24 hours
|
Number of leakages per 24 hours
|
At the urodynamic assessment, up to 24 hours
|
Number of used pads per 24 hours
Time Frame: At the urodynamic assessment, up to 24 hours
|
Number of used pads per 24 hours
|
At the urodynamic assessment, up to 24 hours
|
Post void residual (mL)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Residual urine remaining in the bladder after voiding.
|
At the urodynamic assessment, up to 10-30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cystometric capacity (mL)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in mL in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Compliance (mL/cmH2O)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in mL/cmH2O in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Bladder volume (mL) at detrusor overactivity
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in mL in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in cmH2O in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Detrusor leak point pressure (cmH2O)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in cmH2O in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Maximum detrusor pressure (cmH2O) during storage phase
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in cmH2O in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Maximum detrusor pressure (cmH2O) during voiding phase
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in cmH2O in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Detrusor pressure at maximum flow
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
Measured in urodynamics
|
At the urodynamic assessment, up to 10-30 minutes
|
Scores in Qualiveen & International Prostate Symptom Score (IPSS)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
At the urodynamic assessment, up to 10-30 minutes
|
|
Scores in Female Sexual Function Index (FSFI) or International Index of Erectile Function (IIEF)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
At the urodynamic assessment, up to 10-30 minutes
|
|
Number of patients with adverse events grade 1 bis 5 following the National Cancer Institute terminology Vers. 4 (Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: At the urodynamic assessment, up to 10-30 minutes
|
At the urodynamic assessment, up to 10-30 minutes
|
Collaborators and Investigators
Investigators
- Study Chair: Marc P Schneider, MD, PhD, Universitätsklinik für Urologie
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UroLUTS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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