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

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status and phase

Terminated
Phase 4

Conditions

Urinary Tract Infections
Overactive Bladder

Treatments

Drug: Periprocedural Antibiotics
Procedure: Injection of OnabotulinumtoxinA (BTX-A)
Drug: Extended Antibiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT03508921
00011112222

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Periprocedural Antibiotics Only
Experimental group
Description:
Patients receive a one-time dose of antibiotics at the time of injection, prior to injection.
Treatment:
Procedure: Injection of OnabotulinumtoxinA (BTX-A)
Drug: Periprocedural Antibiotics
Extended Antibiotics
Experimental group
Description:
Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.
Treatment:
Drug: Extended Antibiotics
Procedure: Injection of OnabotulinumtoxinA (BTX-A)
Drug: Periprocedural Antibiotics

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems