Emotional Urinary Tract Infection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Females over the age of 18 years with recurrent uncomplicated UTIs.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

170 Participants
are grouped into 1 trial group
Group A: Questionnaires to assess emotional distress

Trial outcomes

Primary outcomes

1

Primary Objective

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.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Secondary Objective

To determine if emotional distress scores is higher at baseline in IC/BPS compared to non-IC/BPS patients and if recurrent UTIs is exacerbates emotional distress more than non-IC/BPS patients by change in the Perceived Stress scale (PSS-10) scores. Total score can range from 0 to 40. Lower score indicate lower perceived stress levels.

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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