Actively Recruiting

Age: 55Years +
FEMALE
NCT07025044

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

Led by Alexis Dieter · Updated on 2025-09-12

40

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

Sponsors

A

Alexis Dieter

Lead Sponsor

M

Medstar Health Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Natal female older than 55 years
  • English-speaking
  • Scheduled to undergo onabotulinum toxin type A for treatment of overactive bladder
  • No menstrual periods for more than 1 year if uterus is still present
  • Planning to take one dose of nitrofurantoin antibiotic at the time of onabotulinum toxin type A injection as per clinic protocol
Not Eligible

You will not qualify if you...

  • Diagnosis of painful bladder syndrome
  • Current symptomatic or suspected urinary tract infection within 30 days before onabotulinum toxin type A injection
  • Use of systemic antibiotics within 30 days
  • Prophylactic antibiotic treatment for recurrent urinary tract infections in the last 12 months
  • Current systemic immunosuppressive therapy, immunotherapy, chemotherapy, or radiation treatment
  • Prior pelvic radiation
  • Use of indwelling catheter or intermittent catheterization

AI-Screening

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Trial Site Locations

Total: 1 location

1

MedStar Urogynecology Clinic

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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