The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT04479709
• Lead Sponsor: MetroHealth Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Study Start: 2021-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary Microbiome	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 Outcome Measures

Name	Time	Method
Adverse events	08/2020 - 08/2021	Adverse events from intradetrusor botox injection
Urinary Microbiome by response	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.
Urinary tract infection	08/2020 - 08/2021	Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection.

Trial Locations

Locations (1)

MetroHealth; 🇺🇸 Cleveland, Ohio, United States