Effects of Microbiological and Immunological Factors on the Lower Urinary Tract (MiLUT)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pelvic Pain; Non-muscle-invasive Bladder Cancer; Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying; Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter; Recurrent Non-catheter Associated UTIs; Acute Catheter-associated UTI (CAUTI); Recurrent Catheter-associated UTI (CAUTI); Non-neurogenic Overactive Bladder Syndrome / LUT Symptoms

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Thomas Kessler Kessler; Phone Number: +41 44 386 38 Prof. Dr. med.; Email: thomas.kessler@balgrist.ch
• Study Contact Backup: Name: Lorenz Leitner, PD Dr. med.; Phone Number: +41 44 386 39 07; Email: lorenz.leitner@balgrist.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8008
      • Recruiting
      • Balgrist University Hospital
      • Contact: Lorenz Leitner, PD Dr. med.; Phone Number: +41 44 386 39 07; Email: lorenz.leitner@balgrist.ch
      • Contact: Thomas Kessler, Prof Dr. med.; Phone Number: +41 44 386 38 45; Email: thomas.kessler@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Several study arms are intended for each of the different urinary pathologies to be studied, which entail different inclusions and exclusion criteria

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort
Arm I: Healthy controls (n=20 stability study I, + n=30 diversity study, n=300 diversity study spont; Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying (n=20 stability; Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying; Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm IV: Acute non-catheter associated UTIs (n=20 stability study + n=30 diversity study); Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm V: Recurrent non-catheter associated UTIs (n=20 stability study + n=30 diversity study); Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm VI: Acute catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study); Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm VII: Recurrent catheter-associated UTI (CAUTI) (n=20 stability study + n=30 diversity study); Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm VIII: Chronic pelvic pain (n=20 stability study + n=30 diversity study); Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm IX: Non-neurogenic overactive bladder syndrome / LUT symptoms (n=20 stability study + n=30 diver; Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary
Arm X: Non-muscle-invasive bladder cancer (n=30 diversity study + n=20 stability study); Bio-sampling: Voided Urine; Vaginal / Urethral swabs; Rectal swabs; Bloodvarious questionnaires3-day bladder diary7-day bowel diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is to evaluate differences in clinical data, immuno- and biome-markers for different LUT diseases. Data to evaluate the primary endpoints consists of:	Clinical Patient Data To evaluate differences in disease-specific clinical data for different LUT diseases, including number of UTIs within the last year, number and name of antibiotics taken, and clinical symptoms.; Immunological Markers To evaluate differences in immunological markers for different LUT diseases, assessed by immune cell profiling of bladder biopsies and bladder washing cytology; Biome-Markers (Microbiome & Metabolomics) To evaluate differences in biome-markers for different LUT diseases, assessed by bacterial and bacteriophage isolation, DNA extraction and 16S rDNA amplicon sequencing (including deep sequencing of the microbiome in specific cases), and metabolomic data including bacterial metabolomic expression profiles in urine and stool samples	1 year

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Kessler Group; Rätsch Group; Slack Group; Boyman Group; Sunagawa Group; Zamboni Group; Loessner Group; McKinney Group; Nexus; Research Group Dirk Bumann; Research Group Christoph Dehio
• Investigators: Principal Investigator: Thomas Kessler, Prof. Dr. med., Universitätsklinik Balgrist

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: 2023-00743