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临床试验/NCT04147793
NCT04147793尚未招募不适用

Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children

King's College London1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
1
主要终点
maximum urethral closure pressure (MUCP).

研究概览

简要总结

The bladder has a muscle that acts like a tap called the sphincter. Just like a tap, when pee is stored the sphincter muscle is closed and during peeing the sphincter opens. Sometimes the sphincter tap does not work properly and can cause problems. If the sphincter is weak there can be urine leak (incontinence). If the sphincter is too strong bladder might not empty properly.

Children who require investigation of their urinary problems are usually assessed with non-invasive tests. Sometimes investigation is with a more invasive test videourodynamics or video cystometrogram (VCMG; this test requires the insertion of catheters into the bladder and rectum. This test provides only indirect information about sphincter function.

It would be helpful to have a more direct test of the sphincter. It will allow better targeted treatments of sphincter problems which are often therapeutically challenging. Urethral pressure profile is a test used in adults to assess the sphincter. Although it has been described in children normal values have not been described.

The research project is to define urethral pressure profile values in children and young people with normal, weak and overactive sphincters.

Urethral pressure profile measurement is invasive as it requires the insertion of a special catheter. It will therefore be performed at the time of other invasive procedures eg VCMG or urology surgery under general anaesthetic.

The study will be conducted at single site, which is a children's hospital. The study will be an observational case controlled study with three arms: controls, those with overactive sphincters and those with underactive sphincters. The study is intended to run over three years.

详细描述

Rationale Bladder problems in children are common resulting in incontinence and social distress.

The bladder performs two functions: storage and emptying. It has two components that act synchronously with each other and allow it to achieve this: the detrusor and the sphincter complex. The detrusor is the muscle in the wall of the bladder. The sphincter complex is a group of muscles that act on the urethra, which is the outlet of the bladder. During storage the detrusor muscle is relaxed while the sphincter complex is closed. During bladder emptying the detrusor muscle contracts while the sphincter relaxes. Abnormal function of either component will result in abnormal bladder function including lower urinary tract symptoms (including frequency urgency, incontinence, difficulty voiding) and danger to the kidneys. Specifically, abnormality of the sphincter will result in either incontinence during storage, or obstructive problems during voiding.

Establishing a bladder diagnosis in children is helped by performing a test of bladder function. In the majority of children this can be done with non-invasive assessments that include bladder diary, flow rates, flow patterns residual volume measurements and electromyogram (EMG) using skin electrodes. However, in some children non-invasive testing is not able to provide enough information and so videocystometry (VCMG), or urodynamics, are performed. These are more invasive tests. Catheters are inserted into the bladder and abdomen (usually the rectum) to measure pressures generated by the detrusor. The flow rate is measured during emptying. Combining this with x-ray fluoroscopy provides additional anatomical information. VCMG provides direct information about the detrusor. Standard VCMG in children do not currently provide direct information about the tone of the sphincter. Information about sphincter function is provided indirectly by measuring the pressures during leaking, or during voiding from analysis of flow, pressure and X-ray imaging.

The investigators believe that there is a need to develop a direct diagnostic test of sphincter function in children. The investigators have a practice where children are seen with both sphincter underactivity and overactivity. Sphincter under- activity is most commonly seen in children with abnormal bladder function as a result of neurological disease (neuropathic bladder). Sphincter incompetence can be difficult to treat in children . A diagnostic test that can better define the condition may allow better targeted treatments. Sphincter overactivity will result in a poorly emptying bladder. However poor bladder emptying can also result from detrusor underactivity. In patients with incomplete bladder emptying it can be difficult to distinguish whether the condition is as a result of underactive detrusor or overactive sphincter (e.g. dysfunctional voiding or high-tone non-relaxing sphincter type conditions). The distinction is important because the two conditions require very different treatments.

There are tests of sphincter function:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Unaccompanied by adult with parental responsibility who can give consent
  • Previous bladder outlet or urethral surgery
  • Other urological disease not mentioned specifically in the treatment group inclusion criteria; including posterior urethral valves, cerebral palsy, inherited metabolic disease
  • Contraindication to Entonox if sedation required for catheter insertion:
  • Conditions where gas may be trapped in a body cavity, eg middle ear occlusion, intestinal obstruction
  • Unable to understand instruction for use of Entonox
  • Evidence urinary tract infection on day UPP measurement
  • Symptoms of dysuria
  • Abnormally cloudy or offensive urine
  • Temperature of 38oc or more
  • Urine dipstick positive nitrates or leucocytes on the day of the study, in the absence of a renal tract stone or indwelling catheter

结局指标

主要结局

maximum urethral closure pressure (MUCP).

时间窗: approximately 3 months

Urodynamics finding

次要结局

  • Urethral pressure profile pattern(approximately 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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