The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

Study Overview
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Brief Summary
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An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have idiopathic OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.

Official Title
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The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder

Conditions
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Overactive Bladder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Women undergoing intradetrusor botox injection with botox 100 U Exclusion Criteria: Current UTI History of recurrent UTI History of antibiotic exposure for any reason (including if response is unknown) Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Microbiome | To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome. | 08/2020 - 08/2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Microbiome by response | To evaluate whether there are differences between responders and non-responders to intradetrusor botox injections in the pre- and post-treatment urinary microbiomes. | 08/2020 - 08/2021 | 
| Urinary tract infection | Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection. | 08/2020 - 08/2021 | 
| Adverse events | Adverse events from intradetrusor botox injection | 08/2020 - 08/2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Urinary microbiome