Emotional Urinary Tract Infection

NCT ID: NCT07191041

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-08-28
• Study Completion Date: 2027-12-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Bilal Chughtai

Chief of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bilal Chughtai, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

NHPP Urology

Syosset, New York, United States

Countries

United States

Central Contacts

Jennifer Manager, Clinical Research

Role: CONTACT

Jpolo1@northwell.edu

516-760-3980

Alia Research Coordinator

Role: CONTACT

Facility Contacts

Jennifer Manager, Clinical Research

Role: primary

Jpolo1@northwell.edu

516-760-3980

References

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.

Reference Type: BACKGROUND

PMID: 17036170 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 6668417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16042729 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 8437248 (View on PubMed)

Other Identifiers

IRB #: 24-0256

Identifier Type: -

Identifier Source: org_study_id