Outlet Obstruction, Urodynamics, Urodynamic Studies
Conditions
Keywords
obstruction, urodynamics
Brief summary
To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the conventional pressure-flow studies according to the ICS standard with regard to the diagnosis of outlet obstruction in men.
Detailed description
The study aims to investigate a change in the measured values of a pressure-flow measurement in male patients between the sitting and lying position using a urinary condom. This offers enormous added value for science, as both a technique for carrying out the measurement and the effect of positioning can be evaluated. Due to anatomical conditions, this project will only be carried out with male patients. By carrying out the individual measurements in different examination positions on the same patient, influences caused by the change in position can be verified. It enables direct comparison of the criteria for outlet obstruction in the same patient and thus leads to confirmation or rejection of the hypothesis that the outlet obstruction criteria can be used for measurements in the supine position in the same way as for the measurement in the sitting position described by ICS. This project is therefore based on the question of whether the known analysis criteria for outlet obstruction are equivalent to the measurements recommended by ICS in the sitting position in male patients in whom pressure-flow studies can only be performed in the supine position. In addition, the use of a urinal condom with a drainage line as an aid or technique during the measurement is being investigated.
Interventions
OTHERBody position during urodynamics
The group defines the body position in which the first and second measurements are taken. Group A: sitting, lying down (s/l). Group B: lying down, sitting (l/s). According to the ICS standard, the third measurement is always taken in a sitting position.
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Genotype and phenotype XY * Age between 18 and 90 years * Signed informed consent form * Ability to understand and follow the study procedures and understand the consent form * possibility ti carry out out the necessary urodynamics as part of the regular clinical examination * assessment of neurogenic and/or non-neurogenic (idiopathic) bladder dysfunction * Spontaneous micturition in a sitting position is possible
Exclusion criteria
* Patients with assistance/patients under guardianship * Patients with latex allergy or cross-allergy (banana, kiwi, fig, avocado) * No spontaneous movement possible in a sitting position * Sitting position not possible due to lack of trunk stability/circulatory problems * Intravesical Botox injection during the last 9 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First sensation of filling, FSF [mL] | Periprocedural | measured during storage phase |
| First desire to void, FDV [mL] | Periprocedural | measured during storage phase |
| Strong desire to void, SDV [mL] | Periprocedural | measured during storage phase |
| Pdet(S) [cmH2O] | Periprocedural | Maximum detrusor pressure, measured during storage phase |
| Electromyography pelvic floor EMG [μV] during storage phase | Periprocedural | — |
| Filling volume [mL] during storage phase | Periprocedural | — |
| Compl [mL/cmH2O] | Periprocedural | Compliance, measured during storage phase |
| Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O]) | Periprocedural | — |
| Detrusor pressure at maximum flow rate (PdetQmax [cmH2O]) | Periprocedural | measured during voiding phase |
| Maximum flow rate (Qmax [mL/s]) during voiding phase | Periprocedural | — |
| Electromyography pelvic floor (EMG [μV]) during voiding phase | Periprocedural | — |
| Flow volume [mL] during voiding phase | Periprocedural | — |
| Residual urine volume (post void residual, PVR [mL]) | Periprocedural | — |
Outcome results
None listed