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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Compliance (mL/cmH2O)(At the urodynamic assessment, up to 10-30 minutes)
• Bladder volume (mL) at detrusor overactivity(At the urodynamic assessment, up to 10-30 minutes)
• Scores in Female Sexual Function Index (FSFI)(At the urodynamic assessment, up to 10-30 minutes)
• Cystometric capacity (mL)(At the urodynamic assessment, up to 10-30 minutes)
• Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity(At the urodynamic assessment, up to 10-30 minutes)
• Detrusor leak point pressure (cmH2O)(At the urodynamic assessment, up to 10-30 minutes)
• Maximum detrusor pressure (cmH2O) during storage phase(At the urodynamic assessment, up to 10-30 minutes)
• Maximum detrusor pressure (cmH2O) during voiding phase(At the urodynamic assessment, up to 10-30 minutes)
• Detrusor pressure at maximum flow(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)(At the urodynamic assessment, up to 10-30 minutes)
• Scores in Qualiveen & International Prostate Symptom Score (IPSS)(At the urodynamic assessment, up to 10-30 minutes)
• International Index of Erectile Function (IIEF)(At the urodynamic assessment, up to 10-30 minutes)