Antibiotic Usage Prior to OnabotulinumtoxinA Injection

NCT04754737 | Recruiting

• 1 other identifier: IRB20-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysis and are not symptomatic for UTI and receive prophylactic antibiotics at the time of intradetrusor onabotulinumtoxinA injection compared to those who do not receive prophylactic antibiotics at the time of injection. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.

Conditions

Antibiotic Stewardship; Overactive Bladder; Onabotulinumtoxin A; UTI

Outcome Measures

Primary Outcomes (1)

• symptomatic UTI

  the number of symptomatic UTIs which occur within the 14 day period after cystoscopic intradetrusor injection of onabotulinumtoxinA

  14 days

Secondary Outcomes (2)

• Percentage of subjective improvement in overactive bladder symptoms

  14-30 days

• Rate of adverse events including dysuria, gross hematuria, and urinary retention

  14-30 days

Study Arms (2)

Prophylactic antibiotic

OTHER

These patients will receive the current standard of care, which is to receive a single dose of prophylactic antibiotics just prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. The specific prophylactic antibiotics will vary depending on patient's prior urine culture sensitivities and patient medication allergies/sensitivities and medical comorbidities.

Other: Prophylactic antibiotic; Procedure: cystoscopic injection of onabotulinumtoxinA

No antibiotics

EXPERIMENTAL

These patients will receive no prophylactic antibiotics prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy.

Other: No antibiotic; Procedure: cystoscopic injection of onabotulinumtoxinA

Interventions

No antibiotic OTHER

No antibiotics will be given prior to intravesical injection of onabotulinumtoxinA

No antibiotics

Prophylactic antibiotic OTHER

This is the current standard of care, this group of patients will be given a single dose of prophylactic antibiotic prior to the injection of onabotulinumtoxinA via cystoscopy

Prophylactic antibiotic

cystoscopic injection of onabotulinumtoxinA PROCEDURE

cystoscopic injection of onabotulinumtoxinA

No antibiotics; Prophylactic antibiotic

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Diagnosis of OAB who have failed 1st and 2nd line therapies per the AUA/SUFU OAB guidelines (including bladder training, dietary modification and pharmacotherapy with an anticholinergic and/or beta-3 agonist)
• Not symptomatic for UTI at the time of injection
• Negative urinalysis at the time of the injection defined as: negative for nitrites and leukocyte esterace, with urine white blood cell count less than 5 per high-power field
• Consent to participate in the study.

You may not qualify if:

• Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection
• Women who are pregnant or planning to become pregnant, women who are breastfeeding
• Concurrent use of onabotulinumtoxinA injection with maximum cumulative dose exceeding 400 units in a 3-month interval.

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator
• Stony Brook University: collaborator
• Northwell Health: collaborator
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Stony Brook Medicine

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Chemoprevention

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Justina Tam, MD

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justina Tam, MD

CONTACT

6314441910; justina.tam@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, un-blinded

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 15, 2021
• Study Start: March 23, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)