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