Clinical trial NCT03508921: Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
Official title: Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Overactive Bladder
Urinary Tract Infections
Keywords: Onabotulinumtoxin
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Allergan Foundation
name: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
First posted: 2018-04-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Post Procedural- Urinary Tract Infection
timeFrame: 3 weeks post-injection
Secondary outcomes:
measure: Urinary Retention
timeFrame: 3 weeks post-injection
measure: Recurrent Urinary Tract Infection
timeFrame: 3 weeks post injection
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Melissa Kaufman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: