Urodynamics: Prone Vs. Seated Position

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• First sensation of filling, FSF [mL] [Срок оценки: Periprocedural]
• First desire to void, FDV [mL] [Срок оценки: Periprocedural]
• Strong desire to void, SDV [mL] [Срок оценки: Periprocedural]
• Pdet(S) [cmH2O] [Срок оценки: Periprocedural]
• Electromyography pelvic floor EMG [μV] during storage phase [Срок оценки: Periprocedural]
• Filling volume [mL] during storage phase [Срок оценки: Periprocedural]
• Compl [mL/cmH2O] [Срок оценки: Periprocedural]
• Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O]) [Срок оценки: Periprocedural]
• Detrusor pressure at maximum flow rate (PdetQmax [cmH2O]) [Срок оценки: Periprocedural]
• Maximum flow rate (Qmax [mL/s]) during voiding phase [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06864117 · 2024-01522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗