The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479709
• Other study ID #: IRB20-00120
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2024
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	MetroHealth	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Palm KM, Abrams MK, Sears SB, Wherley SD, Alfahmy AM, Kamumbu SA, Chakraborty NN, Mahajan ST, El-Nashar SA, Henderson JW, Hijaz AK, Mangel JM, Pollard RR, Al-Shakhshir H, Retuerto MA, Steller KM, Elshaer M, Ghannoum MA, Sheyn D. The Response of the Urinar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Microbiome	To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.	08/2020 - 08/2021
Secondary	Urinary Microbiome by response	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
Secondary	Urinary tract infection	Determine if there is a relationship between pre- or post-intradetrusor botox injection and the rate of urinary tract infection.	08/2020 - 08/2021
Secondary	Adverse events	Adverse events from intradetrusor botox injection	08/2020 - 08/2021