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

Phase 4

Terminated

• Conditions: Urinary Tract Infections; Overactive Bladder
• Interventions: Drug: Periprocedural Antibiotics; Procedure: Injection of OnabotulinumtoxinA (BTX-A); Drug: Extended Antibiotics

• Registration Number: NCT03508921
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-26
• Study Start: 2018-07-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Results First Submitted: 2023-06-17
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Results First Posted: 2023-11-02
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Post Procedural- Urinary Tract Infection	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 Outcome Measures

Name	Time	Method
Urinary Retention	3 weeks post-injection	Number of participants with urinary retention \> 250 cc post-procedurally as measured by post void residual volume using a bladder scanner in clinic.
Recurrent Urinary Tract Infection	3 weeks post injection	Number of participants with 3 or greater post procedural- urinary tract infection after injections, measured by a urine culture and defined as a urine culture with \>10\^5 bacterial colonies in the setting of urinary symptoms.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States