Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
The Cleveland Clinic
Summary
The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in/urgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the "self-start" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.
Description
Study Procedure and Intervention Following enrollment and consent, participants will be randomized into two groups allocated 1:1 as follows: * Intervention Group: Standing Prescription (Self-Start) + Sterile Urine Cup * Control Group: Standard Triage Line. Provider stratified block randomization (block size 4) will be implemented by REDCap randomization module on the day of participants scheduled procedure. At this point, each participant will be given a unique Study ID number to allow study coordinators to commence data abstraction from the EMR (EPIC) into REDCap. All participants, regard…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female patients of all races and ethnicities aged 18 years and older. * Diagnosis of Overactive Bladder (OAB) and/or Urge Urinary Incontinence (UUI). * Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management. * Has decision making capacity to provide informed consent and comply with and follow study protocols. * Ability to navigate a computer system independently * Access to MyChart and email account Exclusion Criteria: * Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter. * History of Se…
Interventions
- DrugMacrobid® Capsules 100 mg
Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture. Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.
- OtherStandard Medical Care (SMC)
Subjects will receive standard of care post-procedure discharge instructions which instruct the following if a urinary tract infection is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic.
Location
- Cleveland ClinicCleveland, Ohio