Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

• Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol

Locations
United States
Washington, D.c.
MedStar Urogynecology Clinic
RECRUITING
Washington D.c.
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 40
Treatments
Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic
Sponsors
Leads: Alexis Dieter
Collaborators: Medstar Health Research Institute

This content was sourced from clinicaltrials.gov