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临床试验/NCT03174600
NCT03174600已完成不适用

The Course of Post-stroke Bladder Problems and Their Relation With Functional, Mental Status and Quality of Life: A Six-month Prospective, Multicenter Study

Hilal Yeşil · Ege University1 个研究点 分布在 1 个国家实际入组 70 人开始时间: 2015年6月1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
70
试验地点
1
主要终点
Change from baseline modified Barthel index at 3rd and 6th months

研究概览

简要总结

The course of post-stroke bladder problems and their relation with functional, mental status and quality of life: A six-month prospective, multicenter study

详细描述

Lower urinary tract symptoms is a broad term of subjective urinary symptoms such as nocturia, urgency, urinary incontinence, and frequency of voiding, defined by the International Continence Society. Several disorders and conditions affecting the nervous system that controls the lower urinary system can result in neurogenic lower urinary tract dysfunction (LUTD). Stroke is one of these conditions. The literature review reveals that there is insufficient data regarding the course of LUTD symptoms other than urinary incontinence in stroke patients, and their relation with functional and mental status. The aim of this prospective, multi-center study was to determine the frequency and course of post-stroke LUTD from early term up to a period of six months, and to investigate the relation of LUTD with functional and mental status and quality of life in stroke patients.

This study was designed as a prospective study and included 70 stroke patients enrolled by the Neurogenic Bladder Study Group from five different centers across Turkey.

The demographic (age, sex, education, marital status and occupation) and clinical characteristics (side of the stroke, cause of the stroke, stroke localization and anticholinergic medication use) of the patients were obtained from the patient files and through face-to-face interviews. In addition, patients were questioned on the post-stroke 1st, 3rd, and 6th months in terms of bladder drainage methods (normal spontaneous urination, use of adjunct maneuvers such as crede, valsalva and tapping, presence of overflow, clean intermittent catheterization use, permanent catheter use) after stroke.

The patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and evaluated using the Brunnstrom motor staging (hand, upper and lower extremities), modified Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test (MMT) on the 1st, 3rd and 6th months.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline modified Barthel index at 3rd and 6th months

时间窗: Up to 6 th months

Modified Barthel Index; is used to measure the disability experienced by the patient in performing activities of daily living. It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities.

Change from baseline mini mental test score at 3rd and 6th months

时间窗: Up to 6 th months

Mini mental test measures cognitive functions such as sense of direction, memory, attention, linguistic function, and visual-spatial abilities, as well as the ability to count, recall things, repeat, and carry out orders.\[19\] The possible score ranges from 0 to 30, with lower scores indicating more severe cognitive function disorders.

Change from baseline incontinence quality of life questionnaire score at 3rd and 6th months

时间窗: Up to 6 th months

Incontinence quality of life questionnaire assessed differences in disease-specific health related quality of life between urinary symptom subgroups. It is comprised of 22 statements designed to elicit subjective evaluations of urinary incontinence (UI)- related effects and concerns.

次要结局

  • Change from baseline Danish Prostatic Symptom Score at 3rd and 6th months(Up to 6 th months)

研究者

发起方
Hilal YeşilEge University
申办方类型
其他
责任方
申办者-研究者
主要研究者

Hilal Yeşil

Assist. Prof.

Ege University

研究点 (1)

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标识符

NCT 编号
NCT03174600
其他研究编号
2017-YAHY

日期

首次提交
(9年前)
首次发布
(9年前)
主要完成日期
(9年前)
研究完成日期
(9年前)
最近核实
最近更新
(9年前)

监管与共享

FDA 监管药物
否
个体参与者数据共享计划
否
是否有结果
否

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