- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479709
The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections
February 13, 2024 updated by: Jeffrey Mangel, MetroHealth Medical Center
The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Women undergoing intradetrusor botox injection with botox 100 U
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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08/2020 - 08/2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
08/2020 - 08/2021
|
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.
|
08/2020 - 08/2021
|
Adverse events
Time Frame: 08/2020 - 08/2021
|
Adverse events from intradetrusor botox injection
|
08/2020 - 08/2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
July 16, 2020
First Submitted That Met QC Criteria
July 16, 2020
First Posted (Actual)
July 21, 2020
Study Record Updates
Last Update Posted (Estimated)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB20-00120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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