Urodynamics: Prone Vs. Seated Position

NCT ID: NCT06864117

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2028-02-28

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.

Conditions

Urodynamic Studies; Urodynamics; Outlet Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A: sitting, lying down(s/l)

Group Type: OTHER

Body position during urodynamics

Intervention Type: OTHER

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.

Goup B: lying down, sitting (l/s)

Group Type: OTHER

Body position during urodynamics

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Winterthur KSW

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024-01522

Identifier Type: -

Identifier Source: org_study_id