RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-09-03
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07025044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Natal female \> 55 years old
  2. * English-speaking
  3. * Scheduled to undergo onabotulinum toxin type A for treatment of OAB
  4. * No menses for \>1 year if uterus in situ
  5. * Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol
  1. * Diagnosis of painful bladder syndrome
  2. * Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure\*
  3. * Systemic antibiotic exposure within 30 days\^
  4. * Prophylactic antibiotic treatment for recurrent UTI within the last 12 months
  5. * Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment
  6. * Prior pelvic radiation
  7. * Indwelling catheter or intermittent catheterization

Contacts and Locations

Study Locations (Sites)

MedStar Urogynecology Clinic
Washington D.C., District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Alexis Dieter

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-09-03
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • onabotulinum toxin type A

Additional Relevant MeSH Terms

  • Overactive Bladder (OAB)
  • Urge Incontinence