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Urodynamics: Prone Vs. Seated Position

K

Kantonsspital Winterthur KSW

Status

Not yet enrolling

Conditions

Urodynamics
Urodynamic Studies
Outlet Obstruction

Treatments

Other: Body position during urodynamics

Study type

Interventional

Funder types

Other

Identifiers

NCT06864117
2024-01522

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Group A: sitting, lying down(s/l)
Other group
Treatment:
Other: Body position during urodynamics
Goup B: lying down, sitting (l/s)
Other group
Treatment:
Other: Body position during urodynamics

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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