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临床试验/NCT04057222
NCT04057222已完成不适用

Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis, a Manometric Study

Gérard Amarenco · Pierre and Marie Curie University1 个研究点 分布在 1 个国家实际入组 30 人开始时间: 2019年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Variation of volume of rectal constant sensation to need to defecate

研究概览

简要总结

Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. Ano-rectal avec urinary disorders are frequent due to specific lesions in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that anorectal and urinary disorders are link, because of similar anatomic ways and control process.

To our knowledge several studies test the effect of rectal distension and bladder sensory function but only one study examined the effect of bladder filling on rectal sensitivity on healthy people. The effect of bladder filling on rectal sensory function in patient with neurological disease stay unknown, while dysfunction often occur concomitant, and therapeutic actions in one organ may influence function of the other.

Anorectal manometry is the gold standard for the evaluation of rectal sensory function and the volume of constant sensation to need to defecate is reported in literature as the most reproducible measure.

Primary aim is to assess the effect of need to void on volume of constant sensation to need to defecate in multiple sclerosis with anorectal symptoms. Secondary aim is to identify the effect of need to void on modulation of rectoanal inhibitory reflex (RAIR) and external anal sphincter resting pressure.

Patient with multiple sclerosis over 18 years old, consulting for anorectal disorders in a tertiary center, with an indication to realize an anorectal manometry are included.

History and treatment, height, weight, Expanded Disability Status Scale (EDSS), anorectal and urinary symptoms severity by Bristol, Neurogenic Bowel Dysfunction (NBD), Cleveland, Kess, Urinary Symptom Score (USP) scores, and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home. 3 void volume with portable sonography are done, and the higher is recorded.

Anorectal manometries are realized by the same doctor, in a specific place, with calm. Before the manometric examination, thermal and vibratory sensory thresholds on the right hand are collected. The patient is then placed in a left lateral position. Then the anorectal manometry's catheter is inserted and collect of the external anal sphincter resting pressure begins. Then the investigator proceed to search for RAIR by 5 brief distensions of the intrarectal balloon with increasing volumes of 10 mL from 10 mL to 50 mL. Finally, the investigator collect the threshold volumes of perception, need and maximum tolerable by gradually distending the intra-rectal balloon to 5 mL/s from 0 mL to 300 mL. Toilets are just next to the table of examination.

Next, patient can urinate. 3 post void residual volume with portable sonography are done, and the higher is recorded.

The same tests are realized after urinate, in the same order. After the classical complete manometry was performed.

Primary outcome is the volume of constant sensation to need to defecate Secondary outcomes are the modulation of RAIR and the external anal sphincter resting pressure. Manometric data are collected.

Influence of age, EDSS, severity of symptoms, manometric data and detrusor overactivity on rectal sensory function will be study in secondary analysis.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

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

  • Multiple sclerosis
  • > 18 years old
  • Anorectal disorders

排除标准

  • full rectal ampullae
  • No bladder sensation
  • inability to understand simple orders

结局指标

主要结局

Variation of volume of rectal constant sensation to need to defecate

时间窗: 1 Day

Difference between volume of rectal constant sensation to need to defecate at strong desire to void and post void, collected by patient declaration when distending the intra-rectal balloon by manual air insufflation at 5 mL/s during

次要结局

  • Variation of amplitude modulation of the RAIR between strong desire to void and just after(1 Day)
  • Variation of external anal sphincter resting pressure between strong desire to void and just after(1 Day)
  • Variation of duration modulation of the RAIR between strong desire to void and just after(1 Day)

研究者

发起方
Gérard AmarencoPierre and Marie Curie University
申办方类型
其他
责任方
申办者-研究者
主要研究者

Gérard Amarenco

Head of Neuro-Urology department, Tenon Hospital

Pierre and Marie Curie University

研究点 (1)

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标识符

NCT 编号
NCT04057222
其他研究编号
GRC-01GREEN

日期

首次提交
(7年前)
首次发布
(7年前)
主要完成日期
(7年前)
研究完成日期
(7年前)
最近核实
最近更新
(6年前)

监管与共享

FDA 监管药物
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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