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临床试验/NCT01978002
NCT01978002已完成不适用

Sensory Sensitivity and Urinary Symptoms in the Female Population

University of Michigan1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Urodynamics

研究概览

简要总结

Bladder pain and discomfort, as well as urinary urgency and frequency, are bothersome symptoms seen frequently in the general population. Clinical diagnostic terms used to describe these symptoms include interstitial cystitis (IC), bladder pain syndrome (BPS), chronic prostatitis, and overactive bladder (OAB), but there is tremendous overlap between these entities, and the distinction between them is based more on eminence than evidence.

Pain and/or sensory sensitivity has been suspected to play a role in the pathogenesis of both bladder pain and urinary urgency/frequency. However, no previous studies have investigated whether entities such as IC/BPS and OAB might merely represent different points in a continuum of bladder sensory sensitivity. Moreover, we know of no studies that have directly compared sensory sensitivity in the bladder to global (i.e. CNS-mediated) sensory sensitivity.

In the study, a team of investigators with complementary expertise will perform a population-based study assessing bladder and overall sensory sensitivity, in a cohort of women representative of the population with respect to the entire continuum of bladder pain (from none to severe), and symptoms of urgency/frequency. These individuals will undergo urodynamics to measure sensory sensitivity in the bladder, as well as pressure pain and auditory loudness thresholds. The Specific Aims are to demonstrate: 1) sensory sensitivity in the bladder is related to sensory sensitivity elsewhere in the body, suggesting a CNS-driven mechanism, and 2) individuals in the population with greater global sensory sensitivity will display: a) more bladder pain, b) more urgency/frequency, and c) other symptoms of centrally-mediated pain states, such as pain in regions other than the bladder, fatigue, and insomnia.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • At least 18 years old

排除标准

  • Neurological disease or disorder affecting the bladder; 2) Previous augmentation cystoplasty or cystectomy; 3) Systemic autoimmune disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis; 4)History of pelvic cancer (colon, bladder, uterus, ovary); 5) Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc); 6) Current pregnancy. These exclusion criteria will be assessed at the time of the initial telephone interview.

结局指标

主要结局

Urodynamics

时间窗: 1 year

Sensation, desire to void, strong desire to void, and maximum cystometric capacity

Auditory Sensory Sensitivity

时间窗: 1 year

Sensitivity for loudness threshold will be performed using pure tone acoustic stimuli at an octave frequency of 2000 Hz and signal range from 40 to 100 dB

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

James Clemens

Principal Investigator

University of Michigan

研究点 (1)

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