Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

Overactive Bladder Clinical Trial

Official title:

Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719285
• Other study ID #: 22-698
• Status: Completed
• Phase: Phase 4
• Start date: December 6, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: September 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder.

The main question it aims to answer are:

• Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics?

Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection.

Researchers will compare incidence of UTI in each group to see if there is a significant difference.

Description:

• After informed consent is obtained, urinalysis will be collected. Post-void residual will also be assessed by bladder scan if not already documented in the electronic medical record in the prior three months.

• Patients with positive urinalysis and symptomatic for UTI will be excluded from the study.

• Patients will be randomized in a 1:1 ratio to one of two groups.

• Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.

• Group 2 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.

• The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy.

• Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeon's standard technique and template.

• Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute.

• Patients will be followed for 4 weeks after the procedure.

• At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period.

• Chart review will occur at 4 weeks to assess for any unreported events.

• Other than this additional phone call, post-operative patient management will not deviate from the standard of care.

• Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators.

• Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture.

• Symptomatic, culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines.

• Symptoms suggestive of urinary retention, such as increased urinary frequency, voiding small amounts of urine, or feelings of incomplete bladder emptying, will result in obtaining a post void residual (PVR) and urinalysis.

• Patients will undergo teaching to perform self, clean intermittent catheterization of the bladder per the discretion of the operating surgeon.

• Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction.

Antibiotic regimens:

Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.

First line:

Group 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Group 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses

Second line:

Group 1: cefalexin 500 mg once pre-procedure Group 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses

Third line:

Group 1: nitrofurantoin 100 mg once pre-procedure Group 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses

Fourth line:

Group 1: ciprofloxacin 500 mg once pre-procedure Group 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with planned in-office bladder onabotulinumtoxinA injection

• Men or Women Age = 18

• Able to read, speak, and write in English

• No contraindication to injection of onabotulinumtoxinA - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation

• Willingness and ability to initiate intermittent catheterization post-treatment if required

• No contraindication to oral antibiotics

• No active antibiotic therapy for any indication at the time of onabotulinumtoxinA injection

• Have not participated in this study before

Exclusion Criteria:

• Any type of catheterization to empty the bladder

• Unwillingness or inability to initiate intermittent catheterization post-treatment if required

• Less than 3 months since last bladder onabotulinumtoxinA injection

• Pregnant and/or breastfeeding

• Active symptomatic UTI the day of the procedure - new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills

• History of recurrent UTI

• Prior development of urinary retention or incomplete bladder emptying after bladder onabotulinumtoxinA injection requiring catheterization of any type

Related Conditions & MeSH terms

• Overactive Bladder
• Overactive Bladder Syndrome
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• Single-Dose Antibiotic
Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure
• Multi-Dose Antibiotic
Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration.	To assess this aim, the rate of postoperative urinary tract infection (UTI) within 4 weeks following bladder onabotulinumtoxinA injection will be compared between groups. Noninferiority will be declared if the incidence of UTI in the single dose group is not more than UTI incidence in the multiple dose group within statistical variability, by the prespecified noninferiority margin.	4 weeks
Secondary	Antibiotic Adverse Events	Summarize rates of adverse events related to antibiotics in each group.	4 weeks
Secondary	Symptomatic Urinary Retention	Estimate the rate of symptomatic urinary retention requiring catheterization among refractory overactive bladder patients who experience a UTI.	4 weeks