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临床试验/NCT04336280
NCT04336280已完成不适用

The Prevalence and Clinical Presentation of Detrusor Underactivity and Its Urodynamic Characteristics

Mutah University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
1
主要终点
Prevalence of detrusor underactivity in Jordan

研究概览

简要总结

Detrusor underactivity (DU) is a known disease of the muscles of the urinary bladder that defined as a weak contraction of the muscle resulting in a failure to achieve complete bladder emptying. Recently, DU as a cause of Lower Urinary Tract Symptoms in both men and women has been increasingly gaining attention. There is a major issue in differentiation of underactive bladder symptoms and other causes of lower urinary tract symptoms such as detrusor hyperactivity and impaired contractility (DHIC), hypersensitive bladder (HSB), detrusor overactivity (DO), bladder outlet obstruction (BOO) and Dysfunctional Voiding (DV). Urodynamics (UDS) is the standard diagnostic tool, it includes invasive recording of the pressure that is produced when the bladder muscle contracts via pressure sensors introduced in the urinary bladder through special types of urethral catheters. This study aims to determine the prevalence of DU along with its symptomatic and urodynamics (UDS) characteristics of DU in Jordanian population through a retrospective chart review.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 87 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients underwent UDS from July 2016 to August 2019

排除标准

  • Patients with neurogenic bladder (NB) due to known underlying neurological disease, history of open pelvic surgery or major abdominal surgery, or using indwelling catheters or clean intermittent catheterization (CIC).

结局指标

主要结局

Prevalence of detrusor underactivity in Jordan

时间窗: 3 years

The proportion of patients with lower urinary tract symptoms found to be affected by Detrusor underactivity

Urodynamics parameters

时间窗: Each test takes around 30-45 minutes, all urodymanics studies were performed during the study period

Urodynamics is a series of tests conducted in an outpatient setting that evaluates the function of the urinary bladder, including physiological parameters of how completely the bladder, sphincter and urethra are storing and releasing urine. These parameters are recorded by pressure sensors that are inserted into the bladder via special urinary catheters to measure the pressure that is generated during storing and releasing urine. The assessment of urodynamic variables is based on bladder capacity, presence of involuntary bladder muscle contractions, bladder volume at 1st sensation of bladder filling, bladder volumes at normal and strong desire for urination, detrusor pressure at maximum flow of urine during voiding, volume voided, and the post-void residual urine volume. All urodynamic testing was performed based on the International Continence Society standards.

Symptomatic presentation of Detrusor underactivity

时间窗: over one month period prior to clinical evaluation during the 3 years time period

Arabic version of the International Prostate Symptom Score was used to assess the prevalence and severity of the symptoms that are associated with detrusor underactivity. The questionnaire includes 8 questions, the 1st 7 questions are about the urinary symptoms (Incomplete emptying, urinary frequency, intermittency, urgency, weak urine stream, straining and nocturia) and the 8th is about Quality of Life due to Urinary Symptoms. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The answers to the 8th question (quality of life) range from "delighted" to "terrible" or 0 to 6.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fadi Sawaqed

Assistant Professor

Mutah University

研究点 (1)

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