Status:
RECRUITING
Antibiotic Usage Prior to OnabotulinumtoxinA Injection
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
Stony Brook University
Conditions:
Antibiotic Stewardship
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
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 overac...
Detailed Description
Intradetrusor injection of onabotulinumtoxinA, which is performed thorough a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04754737
Start Date
March 23 2021
End Date
December 1 2026
Last Update
May 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stony Brook Medicine
Stony Brook, New York, United States, 11794