跳至主要内容
临床试验/NCT06864117
NCT06864117尚未招募不适用

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

Kantonsspital Winterthur KSW0 个研究点目标入组 200 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
First sensation of filling, FSF [mL]

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

First sensation of filling, FSF [mL]

时间窗: Periprocedural

measured during storage phase

First desire to void, FDV [mL]

时间窗: Periprocedural

measured during storage phase

Pdet(S) [cmH2O]

时间窗: Periprocedural

Maximum detrusor pressure, measured during storage phase

Electromyography pelvic floor EMG [μV] during storage phase

时间窗: Periprocedural

Filling volume [mL] during storage phase

时间窗: Periprocedural

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

时间窗: Periprocedural

measured during voiding phase

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

时间窗: Periprocedural

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

时间窗: Periprocedural

Flow volume [mL] during voiding phase

时间窗: Periprocedural

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

时间窗: Periprocedural

Strong desire to void, SDV [mL]

时间窗: Periprocedural

measured during storage phase

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

时间窗: Periprocedural

Compl [mL/cmH2O]

时间窗: Periprocedural

Compliance, measured during storage phase

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验