Prospective Cohort Study of Patients With Lower Urinary Tract Dysfunction Undergoing Urodynamic Examination for the Assessment of Quality, Cost and Treatment Success
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Post void residual (mL)
研究概览
简要总结
Lower urinary tract dysfunction (LUTD) is a very common complication of urological, gynecological, neurological, metabolic, inflammatory or tumor disease. LUTD is not an inevitable condition, the investigators can help in many ways. Modern clinical examinations like urodynamics allow for patient tailored treatment strategies. Urodynamics however, even if minimal invasive, may lead to urinary tract infections and are very expensive4. Aim of this study is to evaluate in the long-term perspective what patients profit of urodynamic examinations and in what patients the investigators could resign to perform urodynamics in the future and or in what patients the interval of urodynamics could be extended. Main objective is to follow in a long-term prospective cohort study, patients suffering of lower urinary tract dysfunction (LUTD). In this observational study the investigators will include all patient undergoing clinical routine urodynamic examination to better address what is the normal course of LUTD with and without Treatment. The aim is to have a prospective urodynamics database allowing to answer questions related to urodynamics.
详细描述
Patients with a clinical indication for routine urodynamic assessment will be included in to this prospective cohort study. All standard urodynamic results as well as the treatment decision will be collected. Patients undergoing repeated urodynamic measurements i.e. spinal cord injured patients with yearly assessments will each time be included allowing for long-term and follow up analysis of both disease progress and therapy success.
Bladder function is rather simple: storage and voiding of urine. The control of the urinary bladder on the other hand is very complex with many areas that still remain unclear, as for example the cross play of the central and and autonomous nervous system. Voiding of the bladder is an active process that is controlled by nervous impulses from the central nervous system. The detrusor muscle is contracted, and the urethral sphincter muscle is relaxed at the same time so that the urine can be drained off.
Uroflow examination in combination with post-void residual assessment (by sonography or catheterization) are a simple but powerful screening tool to evaluate bladder function. Since both the uroflow as well as the post-void residual are dependent on the detrusor pressure and the infravesical resistance they do not allow for differentiation between hypocontractile detrusor muscle and infravesical obstruction or a combination of both. To do so, the minimal invasive Urodynamic examination is needed. Cystomanometry for the assessment of the bladder storage phase and a pressure-flow for the assessment of the voiding phase. By a thin transurethral catheter, body warm fluid is filled in to the bladder and at the same time is the intravesical and abdominal pressure traced with a computer system. The pelvic floor muscle activity (i.e. the urethral sphincter muscle) is assessed at the same time using EMG surface electrodes.
For Video-Urodynamics, Contrast agent is mixed in to the body warm infusion solution allowing to judge bladder configuration (i.e. diverticula or trabeculation) and if there is vesico-uretero-renal reflux.
Patients with a clinical indication for routine urodynamic assessment will be included in to this prospective cohort study. All standard urodynamic results as well as the treatment decision will be collected. Patients undergoing repeated urodynamic measurements i.e. spinal cord injured patients with yearly assessments will each time be included allowing for long-term and follow up analysis of both disease progress and therapy success.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •Female and male patients, age >18 years
- •Informed consent
- •Lower urinary tract symptoms
- •Planned clinical routine urodynamic examination
排除标准
- •The presence of any of the following exclusion criteria will lead to exclusion of the participant:
- •Age <18 years
- •Pregnancy or breast feeding
- •Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences https://www.samw.ch/en/Publications/Medical-ethical-Guidelines.html)
- •No informed consent
- •Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
结局指标
主要结局
Post void residual (mL)
时间窗: At the urodynamic assessment, up to 10-30 minutes
Residual urine remaining in the bladder after voiding.
Number of voids per 24 hours
时间窗: At the urodynamic assessment, up to 24 hours
Number of voids per 24 hours
Number of leakages per 24 hours
时间窗: At the urodynamic assessment, up to 24 hours
Number of leakages per 24 hours
Number of used pads per 24 hours
时间窗: At the urodynamic assessment, up to 24 hours
Number of used pads per 24 hours
次要结局
- Compliance (mL/cmH2O)(At the urodynamic assessment, up to 10-30 minutes)
- Bladder volume (mL) at detrusor overactivity(At the urodynamic assessment, up to 10-30 minutes)
- Scores in Female Sexual Function Index (FSFI)(At the urodynamic assessment, up to 10-30 minutes)
- Cystometric capacity (mL)(At the urodynamic assessment, up to 10-30 minutes)
- Maximum detrusor pressure amplitude (cmH2O) at detrusor overactivity(At the urodynamic assessment, up to 10-30 minutes)
- Detrusor leak point pressure (cmH2O)(At the urodynamic assessment, up to 10-30 minutes)
- Maximum detrusor pressure (cmH2O) during storage phase(At the urodynamic assessment, up to 10-30 minutes)
- Maximum detrusor pressure (cmH2O) during voiding phase(At the urodynamic assessment, up to 10-30 minutes)
- Detrusor pressure at maximum flow(At the urodynamic assessment, up to 10-30 minutes)
- Number of patients with adverse events grade 1 bis 5 following the National Cancer Institute terminology Vers. 4 (Common Terminology Criteria for Adverse Events (CTCAE)(At the urodynamic assessment, up to 10-30 minutes)
- Scores in Qualiveen & International Prostate Symptom Score (IPSS)(At the urodynamic assessment, up to 10-30 minutes)
- International Index of Erectile Function (IIEF)(At the urodynamic assessment, up to 10-30 minutes)