The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

  • STATUS
    Recruiting
  • days left to enroll
    41
  • participants needed
    60
  • sponsor
    MetroHealth Medical Center
Updated on 27 April 2022
botox
solifenacin
antimuscarinic
onabotulinumtoxina

Summary

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.

Details
Condition Overactive Bladder
Clinical Study IdentifierNCT04479709
SponsorMetroHealth Medical Center
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
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