Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
The Cleveland Clinic
* After informed consent is obtained, urinalysis will be collected. Post-void residual will also be assessed by bladder scan if not already documented in the electronic medical record in the prior three months. * Patients with positive urinalysis and symptomatic for UTI will be excluded from the study. * Patients will be randomized in a 1:1 ratio to one of two groups. * Group 1 will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. * Group 2 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. * Bladder onabotulinumtoxinA injection and dosing will be completed based on the surgeon's standard technique and template. * Bladder onabotulinumtoxinA injection will be completed by staff or fellows in the Female Pelvic Medicine and Reconstructive Surgery division of the Genitourinary and Kidney Institute. * Patients will be followed for 4 weeks after the procedure. * At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. * Chart review will occur at 4 weeks to assess for any unreported events. * Other than this additional phone call, post-operative patient management will not deviate from the standard of care. * Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. * Patients that report symptoms suggestive of a UTI will result in obtaining a urine culture. * Symptomatic, culture proven UTIs will be treated with appropriate antibiotics per the current AUA guidelines. * Symptoms suggestive of urinary retention, such as increased urinary frequency, voiding small amounts of urine, or feelings of incomplete bladder emptying, will result in obtaining a post void residual (PVR) and urinalysis. * Patients will undergo teaching to perform self, clean intermittent catheterization of the bladder per the discretion of the operating surgeon. * Any adverse reactions to the prescribed antibiotic will result in discontinuation of the antibiotic and managed according to the severity of the reaction. Antibiotic regimens: 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: Group 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Group 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Group 1: cefalexin 500 mg once pre-procedure Group 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Group 1: nitrofurantoin 100 mg once pre-procedure Group 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Group 1: ciprofloxacin 500 mg once pre-procedure Group 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
