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

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.

Conditions

• Overactive Bladder
• Urinary Tract Infections

Interventions

DRUG

Periprocedural Antibiotics

One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection.

DRUG

Extended Antibiotics

Patients randomized to the "Extended Antibiotics" arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days. For their second injection, they will receive peri-procedural antibiotics only.

PROCEDURE

Injection of OnabotulinumtoxinA (BTX-A)

Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml.

Sponsors & Collaborators

• The Allergan Foundation

  collaborator OTHER

• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Melissa Kaufman, MD, PhD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2022-06-01

Completion

2022-06-01

FDA Drug

Yes

Countries

• United States

Study Locations