Emotional Urinary Tract Infection

NCT07191041 | Not Yet Recruiting

• 1 other identifier: IRB #: 24-0256
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infection(UTI); Recurrent Urinary Tract Infections

Outcome Measures

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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Secondary Objective

  Through study completion, an average of 1 year

Study Arms (1)

Questionnaires to assess emotional distress

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).

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

NHPP Urology

Syosset, New York, 11791, United States

Location

Related Publications (6)

• Stanford E, McMurphy C. There is a low incidence of recurrent bacteriuria in painful bladder syndrome/interstitial cystitis patients followed longitudinally. Int Urogynecol J Pelvic Floor Dysfunct. 2007 May;18(5):551-4. doi: 10.1007/s00192-006-0184-9. Epub 2006 Oct 12.

  PMID: 17036170 BACKGROUND

• Cihan A, Cihan E, Çakmak B. Perceived Stress and Accompanying Low Urine pH Are in Relation to Bladder Pain Syndrome. Journal of Urological Surgery. 2021;8:98-105.

  BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Clayson D, Wild D, Doll H, Keating K, Gondek K. Validation of a patient-administered questionnaire to measure the severity and bothersomeness of lower urinary tract symptoms in uncomplicated urinary tract infection (UTI): the UTI Symptom Assessment questionnaire. BJU Int. 2005 Aug;96(3):350-9. doi: 10.1111/j.1464-410X.2005.05630.x.

  PMID: 16042729 BACKGROUND

• Chen W-C, Lee M-H, Wu H-C. Relationship among symptoms, mood, and personality traits in patients with interstitial cystitis/bladder pain syndrome. Urological Science. 2017;28(3):147-151.

  BACKGROUND

• Koziol JA, Clark DC, Gittes RF, Tan EM. The natural history of interstitial cystitis: a survey of 374 patients. J Urol. 1993 Mar;149(3):465-9. doi: 10.1016/s0022-5347(17)36120-7.

  PMID: 8437248 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bilal Chughtai, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Manager, Clinical Research

CONTACT

516-760-3980; Jpolo1@northwell.edu

Alia Research Coordinator

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Urology

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: September 24, 2025
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)