NCT07494864Recruiting

Effects of Microbiological and Immunological Factors on the Lower Urinary Tract

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

Millions of patients of all ages suffer worldwide from diverse urinary pathologies, such as lower urinary tract (LUT) dysfunction, bladder pain syndrome, urinary tract infections (UTIs), or bladder cancer. The research project investigates the interplay between the bladder and the microbiome. The goal is to evaluate the association of microbiological and immunological factors with lower urinary tract health in humans.

Status (registry): Recruiting
Study type: Observational
Enrollment: 800 (estimated)
First submitted: 10 Mar 2026
Start date: 1 Jun 2023
Primary completion date: 30 Nov 2026
Lead sponsor: University of Zurich
Diseases: Bladder cancer
NCT number: NCT07494864

What you commit to

Study type: Observational
Planned participants: 800
From 1 Jun 2023 to the primary completion date, 30 Nov 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Immunomodulatory therapies (apart from routine vaccination)
Immunosuppressant therapy (study arm I only)
Need for antiviral medication (study arm I only)
Drug/alcohol dependence (as defined by DSM-IV) any time during the 6 months preceding study entry.
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.

Other illness

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)
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.
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.
History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.

Lab values

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.
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).

Other

Current antibiotic treatment or antibiotic treatment within the last 21 days (except for study arms IV-VII)
Deterioration of the upper urinary tract requiring medical intervention
Congenital or acquired malformations of the LUT (study arm I only)

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Balgrist University Hospital Coordinator of this site? Confirm its status	Zurich	Switzerland	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.