Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success

Lower Urinary Tract Symptoms Clinical Trial

— UroLUTS  

Official title:

Prospective Cohort Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05809154
• Other study ID #: UroLUTS
• Status: Withdrawn
• Start date: January 2019
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urodynamics

Intervention

Diagnostic Test:
• Video-Urodynamics
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of voids per 24 hours	Number of voids per 24 hours	At the urodynamic assessment, up to 24 hours
Primary	Number of leakages per 24 hours	Number of leakages per 24 hours	At the urodynamic assessment, up to 24 hours
Primary	Number of used pads per 24 hours	Number of used pads per 24 hours	At the urodynamic assessment, up to 24 hours
Primary	Post void residual (mL)	Residual urine remaining in the bladder after voiding.	At the urodynamic assessment, up to 10-30 minutes
Secondary	Cystometric capacity (mL)	Measured in mL in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Compliance (mL/cmH2O)	Measured in mL/cmH2O in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Bladder volume (mL) at detrusor overactivity	Measured in mL in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity	Measured in cmH2O in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Detrusor leak point pressure (cmH2O)	Measured in cmH2O in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Maximum detrusor pressure (cmH2O) during storage phase	Measured in cmH2O in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Maximum detrusor pressure (cmH2O) during voiding phase	Measured in cmH2O in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Detrusor pressure at maximum flow	Measured in urodynamics	At the urodynamic assessment, up to 10-30 minutes
Secondary	Scores in Qualiveen & International Prostate Symptom Score (IPSS)		At the urodynamic assessment, up to 10-30 minutes
Secondary	Scores in Female Sexual Function Index (FSFI) or International Index of Erectile Function (IIEF)		At the urodynamic assessment, up to 10-30 minutes
Secondary	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)		At the urodynamic assessment, up to 10-30 minutes