How bladder microbes and immune signals affect lower urinary tract health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project enrolls adults across multiple groups — healthy controls and people with asymptomatic bacteriuria, catheter users, acute or recurrent UTIs, chronic pelvic pain, overactive bladder, or non‑muscle‑invasive bladder cancer — and collects repeated urine samples by in‑and‑out catheterization. Researchers will analyze urinary microbial communities and immune markers to identify patterns associated with symptoms and disease states. Clinical information and laboratory assays will be combined to explore correlations between microbiological and immunological factors and lower urinary tract outcomes. Most participants are excluded if they have recent antibiotic use (within 21 days) except for specified UTI arms.

Why it matters

Who can join: the full rules

General inclusion criteria:

* Women and men aged ≥ 18 years old
* Able to give informed consent for participation in the study
* Willing to adhere to the study protocol for the whole trial period
* Willing to undergo repetitive in-and-out single catheterization Specific inclusion criteria for the different study arms Arm I: Healthy controls Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying Arm IV: Acute non-catheter associated UTIs Arm V: Recurrent non-catheter associated UTIs Arm VI: Acute catheter-associated UTI Arm VII: Recurrent catheter-associated UTI Arm VIII: Chronic pelvic pain Arm IX: Non-neurogenic overactive bladder syndrome Arm X: Non-muscle-invasive bladder cancer

Exclusion Criteria:

* Current antibiotic treatment or antibiotic treatment within the last 21 days (except for study arms IV-VII)
* UTI secondary to diagnosed treatable pathologies (i.e., bladder stones, enterovesical fistula etc.) and requiring specific therapy Current therapies for preventing UTIs (e.g., urine acidification, phytotherapy) or such therapies within the last 21 days (except for study arms IV-VII)
* Deterioration of the upper urinary tract requiring medical intervention
* Immunomodulatory therapies (apart from routine vaccination)
* Congenital or acquired malformations of the LUT (study arm I only)
* Immunosuppressant therapy (study arm I only)
* Need for antiviral medication (study arm I only)
* Significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known AIDS) or kidney disease; or active malignancy (except from bladder cancer) or any other condition as determined by history or laboratory investigation that could cause susceptibility to infections.
* Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV)) that could reasonably have been expected to subject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.
* Drug/alcohol dependence (as defined by DSM-IV) any time during the 6 months preceding study entry.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
* Suspected inability to follow the procedures of the trial (e.g., language problems, psychological disorders, dementia) such that the validity of the patient's data could be compromised.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation.
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.

Where it's running

• Balgrist University Hospital
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Thomas Kessler, Prof. Dr. med. — Universitätsklinik Balgrist
• Study coordinator: Thomas Kessler Kessler
• Email: thomas.kessler@balgrist.ch
• Phone: Prof. Dr. med.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.