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Effects of Microbiological and Immunological Factors on the Lower Urinary Tract

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Switzerland
Balgrist University Hospital
RECRUITING
Zurich
Contact Information
Primary
Thomas Kessler Kessler
thomas.kessler@balgrist.ch
Prof. Dr. med.
Backup
Lorenz Leitner, PD Dr. med.
lorenz.leitner@balgrist.ch
+41 44 386 39 07
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 800
Treatments
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
Sponsors
Collaborators: Slack Group, Research Group Christoph Dehio, Loessner Group, Kessler Group, Boyman Group, Rätsch Group, Zamboni Group, Research Group Dirk Bumann, Nexus, McKinney Group, Sunagawa Group
Leads: University of Zurich

This content was sourced from clinicaltrials.gov