Recruiting

OnabotulinumtoxinA

Sponsor:

Benaroya Research Institute

Code:

NCT04754737

Conditions

Antibiotic Stewardship

Overactive Bladder

Onabotulinumtoxin A

UTI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

No antibiotic

Prophylactic antibiotic

cystoscopic injection of onabotulinumtoxinA

Study Details

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

Study ID

NCT04754737

Start date

Mar 23, 2021

Status verified date

Apr, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Prophylactic antibiotic

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.

experimental: No antibiotics

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

Interventions

No antibiotic

No antibiotics will be given prior to intravesical injection of onabotulinumtoxinA

Prophylactic antibiotic

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

cystoscopic injection of onabotulinumtoxinA

cystoscopic injection of onabotulinumtoxinA

Primary outcome measure

  • symptomatic UTI [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Justina Tam, MD

631-444-1910

More Information

Sponsor

Benaroya Research Institute

Last update posted

May 24, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2024-05-24.