Urodynamics: Prone Vs. Seated Position

Not Applicable

Not yet recruiting

• Conditions: Urodynamic Studies; Urodynamics; Outlet Obstruction

• Registration Number: NCT06864117
• Lead Sponsor: Kantonsspital Winterthur KSW

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.

Study Timeline

• Study First Submitted: 2025-02-25
• Study Start: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
First sensation of filling, FSF [mL]	Periprocedural	measured during storage phase
First desire to void, FDV [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
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
Strong desire to void, SDV [mL]	Periprocedural	measured during storage phase
Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])	Periprocedural
Compl [mL/cmH2O]	Periprocedural	Compliance, measured during storage phase