Urinary Tract Infection(UTI)UTINCT07191041
Emotional Urinary Tract Infection
An observational study of Urinary Tract Infection(UTI) and Recurrent Urinary Tract Infections, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infection(UTI), Recurrent Urinary Tract Infections
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females over the age of 18 years with recurrent uncomplicated UTIs.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alia Research Coordinator contact
United States1 site
NHPP Urology
Syosset, New York, 11791
Jennifer Manager, Clinical Research, 516-760-3980, Jpolo1@northwell.edu
About this study
Official title: Emotional Distress in Recurrent Urinary Tract Infection
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.
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start28 Aug 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection(UTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Chughtai, Northwell Health
- Investigators
- Bilal Chughtai, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191041
- Sponsor's protocol ID
- IRB #: 24-0256
- Acronym
- UTI
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared as supplementary material accompanying the publication of the study results.
Publications
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.
PubMed 17036170Cihan 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.
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.
PubMed 6668417Clayson 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.
PubMed 16042729Chen 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.
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.
PubMed 8437248
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Distress in Recurrent Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT07191041
- Acronym / sponsor ID
- UTI / IRB #: 24-0256
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females over the age of 18 years with recurrent uncomplicated UTIs.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Objective
Time frame: 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.
1 secondary outcome
Secondary Objective
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 17036170Stanford 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.
- BackgroundCihan 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: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 16042729Clayson 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.
- BackgroundChen 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: PubMed 8437248Koziol 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.
- Individual participant dataSharing planned: Undecided. IPD may be shared as supplementary material accompanying the publication of the study results.
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UTI - Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alia Research Coordinator contact
Bilal Chughtai, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection(UTI) and Recurrent Urinary Tract Infections, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Manager, Clinical Research (516-760-3980, Jpolo1@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07191041, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.