Effects of Microbiological and Immunological Factors on the Lower Urinary Tract

NCT07494864 | Recruiting

• 1 other identifier: 2023-00743
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pelvic Pain; Non-neurogenic Overactive Bladder Syndrome / LUT Symptoms; 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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (10)

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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-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 * Blood * various questionnaires * 3-day bladder diary * 7-day bowel diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rätsch Group: collaborator
• Slack Group: collaborator
• Nexus: collaborator
• Research Group Dirk Bumann: collaborator
• University of Zurich: lead
• Kessler Group: collaborator
• Boyman Group: collaborator
• Sunagawa Group: collaborator
• Zamboni Group: collaborator
• Loessner Group: collaborator
• McKinney Group: collaborator
• Research Group Christoph Dehio: collaborator

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Kessler, Prof. Dr. med.

  Universitätsklinik Balgrist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Kessler Kessler

CONTACT

Prof. Dr. med.; thomas.kessler@balgrist.ch

Lorenz Leitner, PD Dr. med.

CONTACT

+41 44 386 39 07; lorenz.leitner@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 27, 2026
• Study Start: June 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CH (1)