Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
Overview
- Phase
- Phase 4
- Intervention
- Periprocedural Antibiotics
- Conditions
- Overactive Bladder
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Post Procedural- Urinary Tract Infection
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Melissa Kaufman
Associate Professor
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Periprocedural Antibiotics Only
Patients receive a one-time dose of antibiotics at the time of injection, prior to injection.
Intervention: Periprocedural Antibiotics
Periprocedural Antibiotics Only
Patients receive a one-time dose of antibiotics at the time of injection, prior to injection.
Intervention: Injection of OnabotulinumtoxinA (BTX-A)
Extended Antibiotics
Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.
Intervention: Periprocedural Antibiotics
Extended Antibiotics
Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.
Intervention: Extended Antibiotics
Extended Antibiotics
Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.
Intervention: Injection of OnabotulinumtoxinA (BTX-A)
Outcomes
Primary Outcomes
Post Procedural- Urinary Tract Infection
Time Frame: 3 weeks post-injection
Number of participants with post procedural- urinary tract infection 3 weeks after injections, measured by a urine culture and defined as a urine culture with \>10\^5 bacterial colonies in the setting of urinary symptoms.
Secondary Outcomes
- Urinary Retention(3 weeks post-injection)
- Recurrent Urinary Tract Infection(3 weeks post injection)