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临床试验/NCT07191041
NCT07191041尚未招募不适用

Emotional Distress in Recurrent Urinary Tract Infection

Northwell Health1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2026年8月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
170
试验地点
1
主要终点
Primary Objective

研究概览

简要总结

This project proposes a rigorous investigation into the psychological impact of positive urine culture results and recurrent urinary tract infections (UTIs) in women, with a particular focus on Interstitial Cystitis and Bladder Pain Syndrome patients. Interstitial cystitis (IC) or bladder pain syndrome (BPS) is a poorly understood chronic disorder that has an immense impact on quality of life. Stress has been demonstrated to exacerbate bladder symptoms in IC/BPS patients. Because it is often difficult to differentiate IC/BPS symptoms from UTIs, laboratory tests such as urine cultures are often obtained to rule out infectious etiology. Positive lab results can disrupt emotion regulation and impact a variety of health-related coping and outcomes. Chen et al demonstrated in a cohort of 57 IC/BPS patients that the pain index was associated with anxiety mood status and a tendency to develop a sense of hopelessness and helplessness. The impact of positive laboratory results has not been investigated in recurrent UTI patients. Identifying triggers for worsening urinary symptoms is important in the overall management of bladder symptoms therefore it is important to evaluate the impact positive lab results on psychosocial stress level in this population in order provide better patient counseling. By employing validated questionnaires and comprehensive assessments, the study aims to provide evidence-based recommendations for patient counseling and management strategies tailored to address emotional distress and symptom severity. The findings will contribute to improving the overall well-being and quality of life for women affected by recurrent UTIs and associated conditions.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Female patients ≥ 18 years of age
  • Diagnosis of recurrent uncomplicated urinary tract infection (≥2 infections in 6 months or ≥3 infections in one year)
  • Ability to complete questionnaires

排除标准

  • Patients who had a urologic procedure in the last 3 months
  • History of bladder malignancy
  • History of exposure to pelvic radiation therapy
  • Unwilling or unable to comply with study data collection

结局指标

主要结局

Primary Objective

时间窗: Through study completion, an average of 1 year

To assess the role laboratory results have on psychological stress level and severity of bladder symptoms in female patients who presents with recurrent uncomplicated UTIs by change in Urinary traction infection symptom assessment (UTISA) scores. The assessment is a 14-item instrument asking about the severity and bothersomeness of seven key uUTI symptoms. Lower score demonstrating less severity and bothersome UTI symptoms.

次要结局

  • Secondary Objective(Through study completion, an average of 1 year)

研究者

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

Bilal Chughtai

Chief of Urology

Northwell Health

研究点 (1)

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