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NCT Number: NCT06864117

Urodynamics: Prone Vs. Seated Position

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.

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Key information

Conditions

Urodynamic Studies Bites and Stings Chemically-Induced Disorders Outlet Obstruction Poisoning Urodynamics Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body position during urodynamics

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.

Primary outcomes

  1. First sensation of filling, FSF [mL]

    Time frame: Periprocedural

    measured during storage phase

  2. First desire to void, FDV [mL]

    Time frame: Periprocedural

    measured during storage phase

  3. Strong desire to void, SDV [mL]

    Time frame: Periprocedural

    measured during storage phase

  4. Pdet(S) [cmH2O]

    Time frame: Periprocedural

    Maximum detrusor pressure, measured during storage phase

  5. Electromyography pelvic floor EMG [μV] during storage phase

    Time frame: Periprocedural

  6. Filling volume [mL] during storage phase

    Time frame: Periprocedural

  7. Compl [mL/cmH2O]

    Time frame: Periprocedural

    Compliance, measured during storage phase

  8. Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])

    Time frame: Periprocedural

  9. Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])

    Time frame: Periprocedural

    measured during voiding phase

  10. Maximum flow rate (Qmax [mL/s]) during voiding phase

    Time frame: Periprocedural

  11. Electromyography pelvic floor (EMG [μV]) during voiding phase

    Time frame: Periprocedural

  12. Flow volume [mL] during voiding phase

    Time frame: Periprocedural

  13. Residual urine volume (post void residual, PVR [mL])

    Time frame: Periprocedural

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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