The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections
Completed
Conditions studied: Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT04479709
- Run by
- MetroHealth Medical Center
- People needed
- 60
- Starts
- 2021-01-01
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2024-02-15
Who can join
Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women undergoing intradetrusor botox injection with botox 100 U
You may not qualify if…
- 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.
Where it is running
- MetroHealth — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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