Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients
NCT ID: NCT06921746
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
80 participants
OBSERVATIONAL
2025-05-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Targeting Microbiota in Female Overactive Bladder Syndrome
NCT05328011
A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
NCT02536872
Bacterial Genomic Sequencing in Overactive Bladder
NCT01642277
The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections
NCT04479709
Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder
NCT01971437
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients will be approached by one of the authorized team members with information about the possibility of participating in this study. If the patient is interested in participating in the study, she will give written informed consent to participate in the study. Subsequently, the inclusion and exclusion criteria for participation in the study will be verified and a standardized urine collection will be performed to examine the characteristics of UMM. At the same time, the patient will fill in standard questionnaires used to determine the severity of OAB symptoms.
To research changes in UMM during OAB treatment, patients will be divided into a group with a good treatment response (responders) and a group without a good treatment response (non-responders). The primary indicator of a good treatment effect (definition of responder) is a reduction in the number of episodes of severe urgency with or without urge incontinence over 3 days documented by a voiding diary by more than 50% compared to the state before treatment. Based on the available data, treatment success is anticipated in 60% of patients.
Subsequently, the study participants will be treated with standard drug treatment for five weeks. They will then be invited to evaluate the effect of treatment using standard symptom questionnaires. At the same time, a control standardized urine collection will be performed to examine the characteristics of UMM. The patients will then end their participation in the study and will continue their treatment according to the valid clinical recommendations for treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Overactive Bladder Patients
Patients with the symptoms of overactive bladder will be enrolled in this study group
Urine Microbiological and Metabolomic Analysis
Microbiological and metabolomic analysis of a urine sample will be performed in the study subjects, before and after the end of the treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Urine Microbiological and Metabolomic Analysis
Microbiological and metabolomic analysis of a urine sample will be performed in the study subjects, before and after the end of the treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written consent to participate in the study
* Willingness to undergo OAB evaluation and treatment according to the protocol
* OAB symptoms lasting longer than 3 months
* At least 3 episodes of severe urgency with or without urge incontinence within 3 days documented by voiding diary
* OAB symptom score V8 questionnaire ≥ 8
Exclusion Criteria
* Any previous treatment for OAB
* Recurrent urinary tract infections (more than 3 episodes in the last 12 months)
* Presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent
* Acute or chronic diseases with possible influence on the function of the lower urinary tract (LUT)
* Rheumatoid arthritis
* Diabetes mellitus
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Bulovka
UNKNOWN
Thomayer University Hospital
OTHER
Institute of Microbiology of the Czech Academy of Sciences
UNKNOWN
University Hospital Ostrava
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Krhut, prof., MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Thomayer University Hospital
Prague, , Czechia
Institute of Microbiology of the Czech Academy of Sciences
Prague, , Czechia
University Hospital Bulovka
Prague, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
Peyronnet B, Mironska E, Chapple C, Cardozo L, Oelke M, Dmochowski R, Amarenco G, Game X, Kirby R, Van Der Aa F, Cornu JN. A Comprehensive Review of Overactive Bladder Pathophysiology: On the Way to Tailored Treatment. Eur Urol. 2019 Jun;75(6):988-1000. doi: 10.1016/j.eururo.2019.02.038. Epub 2019 Mar 26.
Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
Agarwal A, Eryuzlu LN, Cartwright R, Thorlund K, Tammela TL, Guyatt GH, Auvinen A, Tikkinen KA. What is the most bothersome lower urinary tract symptom? Individual- and population-level perspectives for both men and women. Eur Urol. 2014 Jun;65(6):1211-7. doi: 10.1016/j.eururo.2014.01.019. Epub 2014 Jan 24.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Zheng H, Wang C, Yu X, Zheng W, An Y, Zhang J, Zhang Y, Wang G, Qi M, Lin H, Wang F. The Role of Metabolomics and Microbiology in Urinary Tract Infection. Int J Mol Sci. 2024 Mar 8;25(6):3134. doi: 10.3390/ijms25063134.
Gupta A, Dwivedi M, Mahdi AA, Gowda GA, Khetrapal CL, Bhandari M. 1H-nuclear magnetic resonance spectroscopy for identifying and quantifying common uropathogens: a metabolic approach to the urinary tract infection. BJU Int. 2009 Jul;104(2):236-44. doi: 10.1111/j.1464-410X.2009.08448.x. Epub 2009 Feb 23.
Bouatra S, Aziat F, Mandal R, Guo AC, Wilson MR, Knox C, Bjorndahl TC, Krishnamurthy R, Saleem F, Liu P, Dame ZT, Poelzer J, Huynh J, Yallou FS, Psychogios N, Dong E, Bogumil R, Roehring C, Wishart DS. The human urine metabolome. PLoS One. 2013 Sep 4;8(9):e73076. doi: 10.1371/journal.pone.0073076. eCollection 2013.
Colella M, Topi S, Palmirotta R, D'Agostino D, Charitos IA, Lovero R, Santacroce L. An Overview of the Microbiota of the Human Urinary Tract in Health and Disease: Current Issues and Perspectives. Life (Basel). 2023 Jun 30;13(7):1486. doi: 10.3390/life13071486.
Antunes-Lopes T, Vale L, Coelho AM, Silva C, Rieken M, Geavlete B, Rashid T, Rahnama'i SM, Cornu JN, Marcelissen T; EAU Young Academic Urologists (YAU) Functional Urology Working Group. The Role of Urinary Microbiota in Lower Urinary Tract Dysfunction: A Systematic Review. Eur Urol Focus. 2020 Mar 15;6(2):361-369. doi: 10.1016/j.euf.2018.09.011. Epub 2018 Sep 28.
Nelson DE, Dong Q, Van der Pol B, Toh E, Fan B, Katz BP, Mi D, Rong R, Weinstock GM, Sodergren E, Fortenberry JD. Bacterial communities of the coronal sulcus and distal urethra of adolescent males. PLoS One. 2012;7(5):e36298. doi: 10.1371/journal.pone.0036298. Epub 2012 May 11.
Salabura A, Luniewski A, Kucharska M, Myszak D, Dolegowska B, Ciechanowski K, Kedzierska-Kapuza K, Wojciuk B. Urinary Tract Virome as an Urgent Target for Metagenomics. Life (Basel). 2021 Nov 19;11(11):1264. doi: 10.3390/life11111264.
Morand A, Cornu F, Dufour JC, Tsimaratos M, Lagier JC, Raoult D. Human Bacterial Repertoire of the Urinary Tract: a Potential Paradigm Shift. J Clin Microbiol. 2019 Feb 27;57(3):e00675-18. doi: 10.1128/JCM.00675-18. Print 2019 Mar.
Mueller ER, Wolfe AJ, Brubaker L. Female urinary microbiota. Curr Opin Urol. 2017 May;27(3):282-286. doi: 10.1097/MOU.0000000000000396.
Monsen T, Ryden P. Flow cytometry analysis using sysmex UF-1000i classifies uropathogens based on bacterial, leukocyte, and erythrocyte counts in urine specimens among patients with urinary tract infections. J Clin Microbiol. 2015 Feb;53(2):539-45. doi: 10.1128/JCM.01974-14. Epub 2014 Dec 3.
Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.
Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012 Mar 13;13(4):260-70. doi: 10.1038/nrg3182.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MicrOAB-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.