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

NCT03508921 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 00011112222
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Urinary Tract Infections

Keywords

Onabotulinumtoxin

Outcome Measures

Primary Outcomes (1)

• Post Procedural- Urinary Tract Infection

  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.

  3 weeks post-injection

Secondary Outcomes (2)

• Urinary Retention

  3 weeks post-injection

• Recurrent Urinary Tract Infection

  3 weeks post injection

Study Arms (2)

Periprocedural Antibiotics Only

EXPERIMENTAL

Patients receive a one-time dose of antibiotics at the time of injection, prior to injection.

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

Extended Antibiotics

EXPERIMENTAL

Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.

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

Interventions

Periprocedural Antibiotics DRUG

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.

Also known as: trimethoprim/sulfamethoxazole

Extended Antibiotics; Periprocedural Antibiotics Only

Extended Antibiotics DRUG

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.

Also known as: trimethoprim/sulfamethoxazole

Extended Antibiotics

Injection of OnabotulinumtoxinA (BTX-A) PROCEDURE

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.

Extended Antibiotics; Periprocedural Antibiotics Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Medication refractory OAB, identified per American Urological Association guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• The Allergan Foundation: collaborator
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Tract Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Early termination due to recruitment and follow-up challenges during the pandemic resulting in failure to accrue statistically significant sample size.

Results Point of Contact

• Title: Melissa Kaufman, MD, PhD Professor of Urology
• Organization: Vanderbilt Medical Center

melissa.kaufman@vumc.org

615-322-3807

Study Officials

• Melissa Kaufman, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 26, 2018
• Study Start: July 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)