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

Overactive Bladder Clinical Trial

Official title:

Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03508921
• Other study ID #: 00011112222
• Status: Terminated
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction, The Allergan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Urinary Retention	Number of participants with urinary retention > 250 cc post-procedurally as measured by post void residual volume using a bladder scanner in clinic.	3 weeks post-injection
Secondary	Recurrent Urinary Tract Infection	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.	3 weeks post injection