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
Sponsors and collaborators
Alexis Dieter
Lead sponsor
MedStar Health
Sponsor institution
Medstar Health Research Institute
Collaborator