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Search / Trial NCT06387329

Bladder Botox UTI Antibiotic Prophylaxis

Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Apr 24, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Intradetrusor Onabotulinumtoxin A Urinary Tract Infection Antibiotic Prophylaxis

ClinConnect Summary

This clinical trial is studying the best way to prevent urinary tract infections (UTIs) in women who are receiving a treatment called intradetrusor onabotulinumtoxinA injections for overactive bladder (OAB) or bladder pain syndrome. The trial is looking to see if a short course of antibiotics taken for three days is more effective than a single dose given at the time of the injection. This is important because many patients experience UTIs after these injections, and finding the right approach can help reduce infections while also minimizing antibiotic use to prevent resistance.

To participate in this trial, women must be at least 18 years old, have a diagnosis of OAB or bladder pain syndrome, and be planning to receive these injections. Participants will be randomly assigned to one of two groups: one will take antibiotics for three days, and the other will take a single dose. Before the procedure, participants will have a urine test to ensure they do not have an existing UTI. After the injections, they will be contacted a month later to check for any symptoms of UTIs. Overall, this study aims to find a safer and more effective way to prevent UTIs for women undergoing this treatment.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All patients 18 years or older being seen at the WRNMMC Urogynecology clinic
  • Diagnosis of OAB or IC/BPS
  • Planning to undergo intradetrusor onabotulinumtoxinA injection for treatment of their OAB or IC/BPS
  • Ability to follow instructions and complete follow up
  • Exclusion Criteria:
  • Contraindication to nitrofurantoin (allergy, CrCl \<30mL/minute)
  • If performed in the operating room, the patient cannot undergo a concurrent procedure that would increase the risk of UTI or require an alternate antibiotic regimen (such as hysterectomy, prolapse repair, or anti-incontinence procedure)
  • Active UTI at the time of procedure
  • Neurogenic bladder
  • Recurrent UTI (3 in 12 month period or 2 in 6 months)
  • Post void residual bladder volume ≥150mL
  • Patient is already taking antibiotics at the time of the procedure
  • Contraindication to onabotulinumtoxinA (allergy, pregnancy, greater than 400 units of onabotulinumtoxinA received in the last 3 months)

About Walter Reed National Military Medical Center

Walter Reed National Military Medical Center (WRNMMC) is a premier medical facility dedicated to providing comprehensive healthcare services to military personnel, their families, and veterans. As a leader in clinical research and trials, WRNMMC focuses on advancing medical knowledge and improving patient outcomes through innovative studies in various fields, including trauma care, infectious diseases, and rehabilitation. The center is committed to upholding the highest ethical standards in research while fostering collaboration among military and civilian healthcare professionals. Its mission is to enhance the health and well-being of service members and the broader community through cutting-edge research and evidence-based practices.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Jordan Gisseman, MD

Principal Investigator

Walter Reed National Military Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported