CClinicalTrials.gg
Not yet recruitingNCT06864117Updated Mar 7, 2025

Urodynamics: Prone Vs. Seated Position

An interventional study of Body position during urodynamics in Urodynamic Studies, Urodynamics and Outlet Obstruction, sponsored by Kantonsspital Winterthur KSW. Not yet recruiting. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by Kantonsspital Winterthur KSW · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Urodynamic Studies
  • Urodynamics
  • Outlet Obstruction

Keywords

  • obstruction
  • urodynamics
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

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

    Other: Body position during urodynamics

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

    Other: Body position during urodynamics

Interventions

  • OtherBody 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.

05

What researchers measure

Primary outcomes

  1. First sensation of filling, FSF [mL]

    measured during storage phase

    Time frame: Periprocedural

  2. First desire to void, FDV [mL]

    measured during storage phase

    Time frame: Periprocedural

  3. Strong desire to void, SDV [mL]

    measured during storage phase

    Time frame: Periprocedural

  4. Pdet(S) [cmH2O]

    Maximum detrusor pressure, measured during storage phase

    Time frame: Periprocedural

  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]

    Compliance, measured during storage phase

    Time frame: Periprocedural

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

    Time frame: Periprocedural

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

    measured during voiding phase

    Time frame: Periprocedural

  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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06864117
Lead sponsor
Kantonsspital Winterthur KSW
Responsible party
Sponsor
First posted
Mar 7, 2025
Start date
Feb 28, 2025 (estimated)
Primary completion
Feb 28, 2028 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Mar 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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