Clinical trial NCT07025044: Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections
Official title: Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overactive Bladder (OAB)
Urge Incontinence
Keywords: onabotulinum toxin type A
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
First posted: 2025-06-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from the patient population treated at a MedStar Urogynecology clinics located across DC, Maryland and Virginia will be recruited and eligible for enrollment. Potential subjects will be identified both via provider referral and through electronic medical record review to identify patients scheduled for onabotulinum toxin type A injection.

Brief 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

Detailed description: Participants will be recruited from MedStar Urogynecology clinics. English-speaking postmenopausal natal female \> 55 years old scheduled to undergo BTX for treatment of overactive bladder (OAB) will be eligible for enrollment.

All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo BTX injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol. Per standard clinic protocol, all patients undergoing BTX receive a one-time dose of oral nitrofurantoin for infection prevention unless they have allergy/contraindication to nitrofurantoin or they are at high risk of UTI (3 or more culture-proven UTIs in the past year). BTX dose, any prior BTX treatments and time since last BTX injection will be recorded.

Voided urine specimens will be collected at the baseline and follow-up visits. Each subject will be asked to complete one self-collection and one clinic-collection at each time point for a total of four collections over the course of the study

Sample size is 40 subjects in this pilot feasibility study. Subjects will be followed for approximately 1 month after BTX injection. Self-collected and clinic-collected urine specimens will be obtained at baseline and 4 weeks after BTX injection. Subjects will also complete baseline questionnaires and validated patient reported outcome measures at baseline and 4 weeks follow-up. Subjects will be provided reimbursement for parking costs ($17/visit) for the procedure visit and for the follow-up visit. Subjects will be provided a payment of $50 upon completion of the follow-up visit activities.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment
* Prior pelvic radiation
* Indwelling catheter or intermittent catheterization

Primary outcomes:
measure: Recruitment
timeFrame: 6 months
Secondary outcomes:
measure: Urine sample collection and comparison
timeFrame: 4 weeks
measure: Onabotulinum toxin type A response
timeFrame: 4 weeks
measure: Onabotulinum toxin type A adverse events
timeFrame: 4 weeks
Other outcomes:
measure: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) score
timeFrame: 4 weeks
measure: Pelvic Floor Distress Inventory-20 (PFDI-20) score
timeFrame: 4 weeks
measure: Incontinence Impact Questionnaire Short Form (IIQ-7) score
timeFrame: 4 weeks
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: 4 weeks
measure: Accountable Health Communities Health-Related Social Needs Screening Tool (AHC HRSN)
timeFrame: Baseline
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 4 weeks
Locations:
Study officials:
References: