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

NCT07025044 | Recruiting FDA Drug

• 1 other identifier: STUDY00009131
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder (OAB); Urge Incontinence

Keywords

onabotulinum toxin type A

Outcome Measures

Primary Outcomes (1)

• Recruitment

  recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB

  6 months

Secondary Outcomes (3)

• Urine sample collection and comparison

  4 weeks

• Onabotulinum toxin type A response

  4 weeks

• Onabotulinum toxin type A adverse events

  4 weeks

Other Outcomes (6)

• International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) score

  4 weeks

• Pelvic Floor Distress Inventory-20 (PFDI-20) score

  4 weeks

• Incontinence Impact Questionnaire Short Form (IIQ-7) score

  4 weeks

Study Arms (1)

Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic

Drug: onabotulinum toxin type a

Interventions

onabotulinum toxin type a DRUG

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.

Also known as: Botox, BTX

Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexis Dieter: lead
• Medstar Health Research Institute: collaborator

Study Sites (1)

MedStar Urogynecology Clinic

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 17, 2025
• Study Start: September 3, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)