Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age55+
SponsorAlexis Dieter

About this trial

Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives:

* Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland * Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics * Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples * Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX

Eligibility criteria

Qualifiers

Natal female > 55 years old

English-speaking

Scheduled to undergo onabotulinum toxin type A for treatment of OAB

No menses for >1 year if uterus in situ

Disqualifiers

Diagnosis of painful bladder syndrome

Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure*

Systemic antibiotic exposure within 30 days^

Prophylactic antibiotic treatment for recurrent UTI within the last 12 months

Trial design

Treatments tested in this trial

  • onabotulinum toxin type a

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Alexis Dieter

Lead sponsor

MedStar Health

Sponsor institution

Medstar Health Research Institute

Collaborator