Urodynamics: Prone Vs. Seated Position

Comparison of Urine Flow Measurements in the Context of Pressure Flow Studies in Men in Supine and Sitting Positions Using a Urinary Condom

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urodynamic Studies; Outlet Obstruction; Urodynamics
• Intervention / Treatment: Other: Body position during urodynamics

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A: sitting, lying down(s/l)	Other: Body 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.
Other: Goup B: lying down, sitting (l/s)	Other: Body 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First sensation of filling, FSF [mL]	measured during storage phase	Periprocedural
First desire to void, FDV [mL]	measured during storage phase	Periprocedural
Strong desire to void, SDV [mL]	measured during storage phase	Periprocedural
Pdet(S) [cmH2O]	Maximum detrusor pressure, measured during storage phase	Periprocedural
Electromyography pelvic floor EMG [μV] during storage phase		Periprocedural
Filling volume [mL] during storage phase		Periprocedural
Compl [mL/cmH2O]	Compliance, measured during storage phase	Periprocedural
Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])		Periprocedural
Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])	measured during voiding phase	Periprocedural
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

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: obstruction; urodynamics
• Other Study ID Numbers: 2024-01522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No