Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

NCT05719285 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 22-698
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder; Overactive Bladder Syndrome; Urge Incontinence; Urinary Incontinence, Urge

Keywords

incontinence; overactive bladder; urge incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Antibiotic Adverse Events

  4 weeks

• Symptomatic Urinary Retention

  4 weeks

Study Arms (2)

1: Single-Dose Antibiotic Prophylaxis

ACTIVE COMPARATOR

Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection.

Drug: Single-Dose Antibiotic

2: Multi-Dose Antibiotic Prophylaxis

ACTIVE COMPARATOR

Patients 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.

Drug: Multi-Dose Antibiotic

Interventions

Single-Dose Antibiotic DRUG

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

Also known as: ARM 1: Single-Dose Antibiotic Prophylaxis

1: Single-Dose Antibiotic Prophylaxis

Multi-Dose Antibiotic DRUG

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

Also known as: ARM 2: Multi-Dose Antibiotic Prophylaxis

2: Multi-Dose Antibiotic Prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Anti-Bacterial Agents; Antibiotic Prophylaxis

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; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Chemoprevention; Drug Therapy; Therapeutics; Premedication

Results Point of Contact

• Title: Dr. Lauren Gleich
• Organization: Cleveland Clinic Foundation

LAURENGLEICHDO@GMAIL.COM

701-330-1669

Study Officials

• Emily Slopnick, MD

  The Cleveland Clinic

  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: SPONSOR

Model Details: Men and women 18 years of age or older with refractory overactive bladder or neurogenic bladder will be randomized in a 1:1 ratio into one of two groups until the targeted sample size is met: * The single dose group will receive one dose of antibiotic prior to intradetrusor Botox injection. * Individuals in the multi-dose group will receive one dose of antibiotic prior to intradetrusor Botox injection and additional antibiotics for a total of three days of antibiotic administration. Random permuted block randomization with block sizes of 2, 4, 6, and 8 will be used to assign eligible patients to treatment groups

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 8, 2023
• Study Start: December 6, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)