Effects of Microbiological and Immunological Factors on the Lower Urinary Tract (NCT07494864) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Switzerland800 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 f…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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: