Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction; The Allergan Foundation
• Treatments: abobotulinumtoxinA; Anti-Bacterial Agents; Antibiotics, Antitubercular; Botulinum Toxins, Type A; onabotulinumtoxinA; Sulfamethoxazole; Trimethoprim

Criteria

Inclusion criteria:

• ≥ 18 years of age

• Medication refractory OAB, identified per American Urological Association guidelines

Exclusion criteria:

• Post void residual urine >150ml on two occasions

• Untreated, symptomatic UTI

• Comorbid neurological conditions, including spinal cord injury, systemic neurologic illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system disease (i.e. brain tumor, stroke)

• Prior pelvic irradiation

• Current or prior bladder malignancy

• Hematuria lacking a clinically appropriate evaluation

• Chronic indwelling or intermittent catheterization