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OpenTrials
Completed

NCT Number: NCT04479709

The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Urinary Microbiome

    Time frame: 08/2020 - 08/2021

    To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.

Secondary outcomes

  1. Urinary Microbiome by response

    Time frame: 08/2020 - 08/2021

    To evaluate whether there are differences between responders and non-responders to intradetrusor botox injections in the pre- and post-treatment urinary microbiomes.

  2. Urinary tract infection

    Time frame: 08/2020 - 08/2021

    Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection.

  3. Adverse events

    Time frame: 08/2020 - 08/2021

    Adverse events from intradetrusor botox injection

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2020
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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