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Recruiting NCT07025044

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

— Observational Overactive Bladder (OAB) Urge Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: onabotulinum toxin type a.
Who it may be relevant to
Registry conditions: Overactive Bladder (OAB), Urge Incontinence. Basic parameters: from 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug onabotulinum toxin type a
    All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo Onabotulinum toxin type A injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol.

Primary outcome measures

  • Recruitment [Time frame: 6 months]
Secondary outcome measures (3)
  • Urine sample collection and comparison [Time frame: 4 weeks]
  • Onabotulinum toxin type A response [Time frame: 4 weeks]
  • Onabotulinum toxin type A adverse events [Time frame: 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • MedStar Urogynecology Clinic — Washington D.C.

Identifiers

NCT: NCT07025044 · STUDY00009131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗