UrodynamicsUroLUTSNCT05809154
Quality, Cost and Treatment Success on Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination
An observational study of Urodynamics and Lower Urinary Tract Symptoms, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Lower urinary tract dysfunction (LUTD) is a very common complication of urological, gynecological, neurological, metabolic, inflammatory or tumor disease. LUTD is not an inevitable condition, the investigators can help in many ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urodynamics, Lower Urinary Tract Symptoms, Neurogenic Bladder
- What is being tested?
- Video-Urodynamics
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 3 Jul 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Prospective Cohort Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success
Lower urinary tract dysfunction (LUTD) is a very common complication of urological, gynecological, neurological, metabolic, inflammatory or tumor disease. LUTD is not an inevitable condition, the investigators can help in many ways. Modern clinical examinations like urodynamics allow for patient tailored treatment strategies. Urodynamics however, even if minimal invasive, may lead to urinary tract infections and are very expensive4. Aim of this study is to evaluate in the long-term perspective what patients profit of urodynamic examinations and in what patients the investigators could resign to perform urodynamics in the future and or in what patients the interval of urodynamics could be extended. Main objective is to follow in a long-term prospective cohort study, patients suffering of lower urinary tract dysfunction (LUTD). In this observational study the investigators will include all patient undergoing clinical routine urodynamic examination to better address what is the normal course of LUTD with and without Treatment. The aim is to have a prospective urodynamics database allowing to answer questions related to urodynamics.
Read the 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.
- Being tested
- Video-Urodynamics
- Keywords
- Urodynamics, Lower Urinary Tract Symptoms, Neurogenic Bladder
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-UrodynamicsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurogenic lower urinary tract dysfunction | Lower urinary tract dysfunction due to any neurological condition like spinal cord injury, multiple sclerosis and others. Receives: Diagnostic Test: Video-Urodynamics | |
| Non-Neurogenic lower urinary tract dysfunction | Lower urinary tract dysfunction in absence of any neurological pathology. Receives: Diagnostic Test: Video-Urodynamics | |
| Chronic pelvic pain | Chronic pelvic pain as defined by the EAU guidelines. Receives: Diagnostic Test: Video-Urodynamics | |
| Urodynamic normal Bladder function | Normal urodynamic findings and absence of chronic pelvic pain. Receives: Diagnostic Test: Video-Urodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of voids per 24 hours
Number of voids per 24 hours
Measured: At the urodynamic assessment, up to 24 hours
Number of leakages per 24 hours
Number of leakages per 24 hours
Measured: At the urodynamic assessment, up to 24 hours
Number of used pads per 24 hours
Number of used pads per 24 hours
Measured: At the urodynamic assessment, up to 24 hours
Post void residual (mL)
Residual urine remaining in the bladder after voiding.
Measured: At the urodynamic assessment, up to 10-30 minutes
Secondary outcomes (12)
Cystometric capacity (mL)
Measured in mL in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Compliance (mL/cmH2O)
Measured in mL/cmH2O in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Bladder volume (mL) at detrusor overactivity
Measured in mL in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity
Measured in cmH2O in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Detrusor leak point pressure (cmH2O)
Measured in cmH2O in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Maximum detrusor pressure (cmH2O) during storage phase
Measured in cmH2O in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Maximum detrusor pressure (cmH2O) during voiding phase
Measured in cmH2O in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Detrusor pressure at maximum flow
Measured in urodynamics
Measured: At the urodynamic assessment, up to 10-30 minutes
Scores in Qualiveen & International Prostate Symptom Score (IPSS)
Score value between 0 and a maximum of 35 points. Interpretation: Mild (IPSS<8), moderate (IPSS=8-19) and severe (IPSS=20-35) symptoms
Measured: At the urodynamic assessment, up to 10-30 minutes
Scores in Female Sexual Function Index (FSFI)
The FSFI1 is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function as well as the primary components of sexual function in women, including sexual desire, arousal, orgasm, pain, and satisfaction. To score the measure of 19 Items, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal; 0.3 for lubrication; 0.4 for orgasm; 0.4 for satisfaction; and 0.4 for pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score. The absence of sexual activity or intercourse is not necessarily attributable to sexual dysfunction. proper scoring and interpretation of the measure necessitates: a) inclusion of a distress measure for diagnosing sexual dysfunction clinically, as defined by current standards; and b) correction for sexual activity status and adapted scoring for sexually inactive respondents.
Measured: 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)
urodynamic assessment
Measured: At the urodynamic assessment, up to 10-30 minutes
International Index of Erectile Function (IIEF)
Based on IIEF, ED severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7).
Measured: At the urodynamic assessment, up to 10-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Jan 2019 (estimated)
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Why it stopped: Personnel changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrodynamicsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc P Schneider, MD, PhD, Study chair, Universitätsklinik für Urologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809154
- Sponsor's protocol ID
- UroLUTS
- Acronym
- UroLUTS
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2018
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success
- ClinicalTrials.gov ID
- NCT05809154
- Acronym / sponsor ID
- UroLUTS / UroLUTS
- Keywords
- Urodynamics, Lower Urinary Tract Symptoms, Neurogenic Bladder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personnel changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- 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.
Lower urinary tract dysfunction (LUTD) is a very common complication of urological, gynecological, neurological, metabolic, inflammatory or tumor disease. LUTD is not an inevitable condition, the investigators can help in many ways. Modern clinical examinations like urodynamics allow for patient tailored treatment strategies. Urodynamics however, even if minimal invasive, may lead to urinary tract infections and are very expensive4. Aim of this study is to evaluate in the long-term perspective what patients profit of urodynamic examinations and in what patients the investigators could resign to perform urodynamics in the future and or in what patients the interval of urodynamics could be extended. Main objective is to follow in a long-term prospective cohort study, patients suffering of lower urinary tract dysfunction (LUTD). In this observational study the investigators will include all patient undergoing clinical routine urodynamic examination to better address what is the normal course of LUTD with and without Treatment. The aim is to have a prospective urodynamics database allowing to answer questions related to urodynamics.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neurogenic lower urinary tract dysfunction | – | Diagnostic Test: Video-UrodynamicsLower urinary tract dysfunction due to any neurological condition like spinal cord injury, multiple sclerosis and others. |
| Non-Neurogenic lower urinary tract dysfunction | – | Diagnostic Test: Video-UrodynamicsLower urinary tract dysfunction in absence of any neurological pathology. |
| Chronic pelvic pain | – | Diagnostic Test: Video-UrodynamicsChronic pelvic pain as defined by the EAU guidelines. |
| Urodynamic normal Bladder function | – | Diagnostic Test: Video-UrodynamicsNormal urodynamic findings and absence of chronic pelvic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
Key exclusion criteria (6 listed)
- The presence of any of the following exclusion criteria will lead to exclusion of the participant:
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 |
|---|---|---|
| Video-UrodynamicsMinimal 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. | Diagnostic test | Chronic pelvic pain, Neurogenic lower urinary tract dysfunction, Non-Neurogenic lower urinary tract dysfunction, Urodynamic normal Bladder function |
Primary outcome
Number of voids per 24 hours
Time frame: At the urodynamic assessment, up to 24 hours
Number of voids per 24 hours
Number of leakages per 24 hours
Time frame: At the urodynamic assessment, up to 24 hours
Number of leakages per 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
Post void residual (mL)
Time frame: At the urodynamic assessment, up to 10-30 minutes
Residual urine remaining in the bladder after voiding.
12 secondary outcomes
Cystometric capacity (mL)
Time frame: At the urodynamic assessment, up to 10-30 minutes
Compliance (mL/cmH2O)
Time frame: 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
Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity
Time frame: 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
Maximum detrusor pressure (cmH2O) during storage phase
Time frame: 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
Detrusor pressure at maximum flow
Time frame: 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
Scores in Female Sexual Function Index (FSFI)
Time frame: 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
International Index of Erectile Function (IIEF)
Time frame: At the urodynamic assessment, up to 10-30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No. We do not share IPD with other researchers.
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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.
Marc P Schneider, MD, PhD study chair
Universitätsklinik für Urologie
Questions about this trial
What is this clinical trial studying?
An observational study of Urodynamics and Lower Urinary Tract Symptoms, run by Insel Gruppe AG, University Hospital Bern.
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 5 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: withdrawn, as of the sponsor's last update on 9 Jul 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of voids per 24 hours (time frame: At the urodynamic assessment, up to 24 hours). The study lists 4 primary outcomes in all. 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 Jul 2024.