An observational study in Urodynamics, Lower Urinary Tract Symptoms and Neurogenic Bladder, sponsored by Insel Gruppe AG, University Hospital Bern. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
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.
411 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
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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.
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Participants fulfilling all of the following inclusion criteria are eligible for the study:
Exclusion Criteria:
The presence of any of the following exclusion criteria will lead to exclusion of the participant:
Lower urinary tract dysfunction due to any neurological condition like spinal cord injury, multiple sclerosis and others.
Diagnostic Test: Video-Urodynamics
Lower urinary tract dysfunction in absence of any neurological pathology.
Diagnostic Test: Video-Urodynamics
Chronic pelvic pain as defined by the EAU guidelines.
Diagnostic Test: Video-Urodynamics
Normal urodynamic findings and absence of chronic pelvic pain.
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.
Number of voids per 24 hours
Number of voids per 24 hours
Time frame: At the urodynamic assessment, up to 24 hours
Number of leakages per 24 hours
Number of leakages per 24 hours
Time frame: At the urodynamic assessment, up to 24 hours
Number of used pads per 24 hours
Number of used pads per 24 hours
Time frame: At the urodynamic assessment, up to 24 hours
Post void residual (mL)
Residual urine remaining in the bladder after voiding.
Time frame: At the urodynamic assessment, up to 10-30 minutes
Cystometric capacity (mL)
Measured in mL in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Compliance (mL/cmH2O)
Measured in mL/cmH2O in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Bladder volume (mL) at detrusor overactivity
Measured in mL in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity
Measured in cmH2O in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Detrusor leak point pressure (cmH2O)
Measured in cmH2O in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Maximum detrusor pressure (cmH2O) during storage phase
Measured in cmH2O in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Maximum detrusor pressure (cmH2O) during voiding phase
Measured in cmH2O in urodynamics
Time frame: At the urodynamic assessment, up to 10-30 minutes
Detrusor pressure at maximum flow
Measured in urodynamics
Time frame: 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
Time frame: 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.
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)
urodynamic assessment
Time frame: 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).
Time frame: At the urodynamic assessment, up to 10-30 minutes
No study locations are listed for this record.
Plan to share: No — We do not share IPD with other researchers.
No publications or documents are linked to this record.
Start is estimated for Jan 2019.
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This study is withdrawn, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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