The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bladder Botox UTI Antibiotic Prophylaxis

NCT06387329

Overactive Bladder Bladder Pain Syndrome

RECRUITING PHASE4

Antibiotic Prophylaxis for Neurogenic Bladder Botox

NCT04791579

Neurogenic Bladder Post-operative Urinary Tract Infections

RECRUITING PHASE2

Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection

NCT04817865

Urinary Tract Infections

WITHDRAWN

Antibiotic Prophylaxis for Bladder Botox

NCT04444440

Idiopathic Overactive Bladder Postoperative Urinary Tract Infection

RECRUITING PHASE4

A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder

NCT02536872

Urogynaecology

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No