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Not yet recruiting NCT06864117

Urodynamics: Prone Vs. Seated Position

No phase Interventional Urodynamic Studies Urodynamics Outlet Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Body position during urodynamics.
Who it may be relevant to
Registry conditions: Urodynamic Studies, Urodynamics, Outlet Obstruction. Basic parameters: 18 years — 90 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • First sensation of filling, FSF [mL] [Time frame: Periprocedural]
  • First desire to void, FDV [mL] [Time frame: Periprocedural]
  • Strong desire to void, SDV [mL] [Time frame: Periprocedural]
  • Pdet(S) [cmH2O] [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] [Time frame: Periprocedural]
  • Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O]) [Time frame: Periprocedural]
  • Detrusor pressure at maximum flow rate (PdetQmax [cmH2O]) [Time frame: Periprocedural]
  • Maximum flow rate (Qmax [mL/s]) during voiding phase [Time frame: Periprocedural]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06864117 · 2024-01522

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗