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The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

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MetroHealth Medical Center

Status

Completed

Conditions

Overactive Bladder

Study type

Observational

Funder types

Other

Identifiers

NCT04479709
IRB20-00120

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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