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Emotional Urinary Tract Infection (UTI)

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Northwell Health

Status

Begins enrollment in 6 months

Conditions

Urinary Tract Infection(UTI)
Recurrent Urinary Tract Infections

Study type

Observational

Funder types

Other

Identifiers

NCT07191041
IRB #: 24-0256

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

170 participants in 1 patient group

Questionnaires to assess emotional distress
Description:
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 using patient-reported questionnaires (UTISA and PSS-10).

Trial contacts and locations

1

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Central trial contact

Alia Research Coordinator; Jennifer Manager, Clinical Research

Data sourced from clinicaltrials.gov

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