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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
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.
First sensation of filling, FSF [mL]
measured during storage phase
Time frame: Periprocedural
First desire to void, FDV [mL]
measured during storage phase
Time frame: Periprocedural
Strong desire to void, SDV [mL]
measured during storage phase
Time frame: Periprocedural
Pdet(S) [cmH2O]
Maximum detrusor pressure, measured during storage phase
Time frame: Periprocedural
Electromyography pelvic floor EMG [μV] during storage phase
Time frame: Periprocedural
Filling volume [mL] during storage phase
Time frame: Periprocedural
Compl [mL/cmH2O]
Compliance, measured during storage phase
Time frame: Periprocedural
Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])
Time frame: Periprocedural
Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])
measured during voiding phase
Time frame: Periprocedural
Maximum flow rate (Qmax [mL/s]) during voiding phase
Time frame: Periprocedural
Electromyography pelvic floor (EMG [μV]) during voiding phase
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Time frame: Periprocedural
Flow volume [mL] during voiding phase
Time frame: Periprocedural
Residual urine volume (post void residual, PVR [mL])
Time frame: Periprocedural