Clinical Trials Directory

Trials / Completed

CompletedNCT04479709

The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

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

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
MetroHealth Medical Center · Academic / Other
Sex
Female
Age
18 Years – 89 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2021-01-01
Primary completion
2022-06-30
Completion
2022-06-30
First posted
2020-07-21
Last updated
2024-02-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04479709. Inclusion in this directory is not an endorsement.