drugset / Trial / NCT03508921
Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
Phase 4
Terminated
22 enrolled
Vanderbilt University Medical Center
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction · collabThe Allergan Foundation · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.
Timeline
- Start
- 2018-07-01
- Primary completion
- 2022-06-01
- Completion
- 2022-06-01
Outcome
Outcome not reported
Stopped (Enrollment): “Early termination due to recruitment and follow-up challenges during the pandemic”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sulfamethoxazole | Small molecule | 800 mg | — |
| Subject | Trimethoprim | Small molecule | 160 mg | — |
| Background | Amoxicillin | Other / unclassified | 875 mg | — |
| Background | Nitrofurantoin | Unknown | 100 mg | — |
| Background | clavulanic acid | Small molecule | 125 mg | — |