Clinical trial NCT06864117: Urodynamics: Prone Vs. Seated Position
Official title: Comparison of Urine Flow Measurements in the Context of Pressure Flow Studies in Men in Supine and Sitting Positions Using a Urinary Condom
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urodynamic Studies
Urodynamics
Outlet Obstruction
Keywords: obstruction
urodynamics
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: First sensation of filling, FSF [mL]
timeFrame: Periprocedural
measure: First desire to void, FDV [mL]
timeFrame: Periprocedural
measure: Strong desire to void, SDV [mL]
timeFrame: Periprocedural
measure: Pdet(S) [cmH2O]
timeFrame: Periprocedural
measure: Electromyography pelvic floor EMG [μV] during storage phase
timeFrame: Periprocedural
measure: Filling volume [mL] during storage phase
timeFrame: Periprocedural
measure: Compl [mL/cmH2O]
timeFrame: Periprocedural
measure: Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])
timeFrame: Periprocedural
measure: Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])
timeFrame: Periprocedural
measure: Maximum flow rate (Qmax [mL/s]) during voiding phase
timeFrame: Periprocedural
measure: Electromyography pelvic floor (EMG [μV]) during voiding phase
timeFrame: Periprocedural
measure: Flow volume [mL] during voiding phase
timeFrame: Periprocedural
measure: Residual urine volume (post void residual, PVR [mL])
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
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Study officials:
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