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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    68
  • sponsor
    Vanderbilt University Medical Center
Updated on 12 February 2022
urinary tract infection
antibiotic therapy
antibiotics
medical therapy
trimethoprim
sulfamethoxazole
clavulanic acid
botulinum toxin type a
botox
onabotulinumtoxina
nitrofurantoin

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.

Description

Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding urinary tract infections (UTI), the most common adverse event following injection. The investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural UTIs and their affect on treatment efficacy.

The investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. Inter-injection time will be measured and used a surrogate for efficacy over multiple injections.

These results, in addition to filling a void in current literature regarding the increasingly utilized treatment with BTX-A, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. The means to stratify patients based on their specific risk of UTI may be used to facilitate antibiotic stewardship and improve patient outcomes.

Details
Condition Overactive Bladder, Urinary Tract Infections
Treatment Periprocedural Antibiotics, Extended Antibiotics, Injection of OnabotulinumtoxinA (BTX-A)
Clinical Study IdentifierNCT03508921
SponsorVanderbilt University Medical Center
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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