Recruiting

Onabotulinum Toxin A

Sponsor:

Alexis Dieter

Code:

NCT07025044

Conditions

Overactive Bladder (OAB)

Urge Incontinence

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

Interventions

onabotulinum toxin type a

Study Details

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

Study ID

NCT07025044

Start date

Sep 3, 2025

Status verified date

Sep, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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 measure

  • Recruitment [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

MedStar Urogynecology Clinic

Recruiting

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

Contacts

Moriarty

202-748-4112Patricia.L.Moriarty@medstar.net

alexis.a.dieter@medstar.net

Principal Investigator:

Alexis Dieter, MD

More Information

Sponsor

Alexis Dieter

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • onabotulinum toxin type A

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexis Dieter on 2025-09-12.