Clinical trial NCT05809154: Quality, Cost and Treatment Success on Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination
Official title: Prospective Cohort Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urodynamics
Lower Urinary Tract Symptoms
Neurogenic Bladder
Keywords: Urodynamics
Lower Urinary Tract Symptoms
Neurogenic Bladder
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of voids per 24 hours
timeFrame: At the urodynamic assessment, up to 24 hours
measure: Number of leakages per 24 hours
timeFrame: At the urodynamic assessment, up to 24 hours
measure: Number of used pads per 24 hours
timeFrame: At the urodynamic assessment, up to 24 hours
measure: Post void residual (mL)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
Secondary outcomes:
measure: Cystometric capacity (mL)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Compliance (mL/cmH2O)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Bladder volume (mL) at detrusor overactivity
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Detrusor leak point pressure (cmH2O)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Maximum detrusor pressure (cmH2O) during storage phase
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Maximum detrusor pressure (cmH2O) during voiding phase
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Detrusor pressure at maximum flow
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Scores in Qualiveen & International Prostate Symptom Score (IPSS)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: Scores in Female Sexual Function Index (FSFI)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: 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)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
measure: International Index of Erectile Function (IIEF)
timeFrame: At the urodynamic assessment, up to 10-30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinik für Urologie
name: Marc P Schneider, MD, PhD
role: STUDY_CHAIR
References: