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| Name | Class |
|---|---|
| University Hospital Bulovka | UNKNOWN |
| Thomayer University Hospital | OTHER |
| Institute of Microbiology of the Czech Academy of Sciences | UNKNOWN |
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This is a non-interventional study that will not pose any burden for the participants. The study subjects will be examined and treated in a standard manner according to current clinical recommendations for the treatment of overactive bladder (OAB). A portion of urine samples, which are routinely collected for biochemical and culture examinations as part of the diagnostic process, will be sent for examination of the characteristics of the urinary microbiome and metabolome (UMM) before and after treatment.
Participation in the study will be offered to female patients who seek treatment for OAB symptoms themselves or are referred to centers participating in the project if a clinical diagnosis of idiopathic OAB is established in their case as part of the standard examination process.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overactive Bladder Patients | Patients with the symptoms of overactive bladder will be enrolled in this study group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine Microbiological and Metabolomic Analysis | Diagnostic Test | Microbiological and metabolomic analysis of a urine sample will be performed in the study subjects, before and after the end of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders to the OAB treatment | The proportion of study subjects responding to the treatment of OAB symptoms will be observed. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UMM characteristics between both groups | Changes in UMM characteristics based on laboratory examination will be compared between the two study groups (responders vs non-responders) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult women with symptoms of overactive bladder persisting longer than three months willing to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jan Krhut, prof., MD, PhD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35216856 | Background | 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. | |
| 30922690 |
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There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Urine samples
| Thomayer University Hospital | Recruiting | Prague | 14059 | Czechia |
|
| Institute of Microbiology of the Czech Academy of Sciences | Recruiting | Prague | 14200 | Czechia |
|
| University Hospital Bulovka | Recruiting | Prague | 18081 | Czechia |
|
| Background |
| 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. |
| 11412210 | Background | 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. |
| 17049716 | Background | 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. |
| 24486308 | Background | 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. |
| 11857671 | Background | 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. |
| 38542107 | Background | 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. |
| 19239442 | Background | 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. |
| 24023812 | Background | 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. |
| 37511861 | Background | 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. |
| 30270128 | Background | 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. |
| 22606251 | Background | 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. |
| 34833140 | Background | 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. |
| 30404941 | Background | 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. |
| 28234750 | Background | Mueller ER, Wolfe AJ, Brubaker L. Female urinary microbiota. Curr Opin Urol. 2017 May;27(3):282-286. doi: 10.1097/MOU.0000000000000396. |
| 25472486 | Background | 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. |
| 17943116 | Background | 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. |
| 22411464 | Background | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |