Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
ConditionOveractive Bladder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter.
History of Severe Renal Impairment Cr/Cl - <60 ml/min 1.73m2
History of recurrent UTIs (defined as >3x symptomatic UTIs in 12 months).
Post-Void Residual (PVR) volume >150 mL.
Trial design
Design model
Parallel
Treatments tested in this trial
Macrobid® Capsules 100 mg
DrugSubjects 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.
Standard Medical Care (SMC)
Other interventionSubjects 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.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine CultureActive comparator 1 intervention
Group B: Standard Triage Line; Standard Medical Care (SMC)Other 1 intervention
Trial outcomes
Primary outcomes
1
Healthcare utilization
Investigate whether providing a standing, take-home prescription for Nitrofurantoin (MACROBID), or other suitable prescription alternate detailed in the "arms and interventions section", is superior to SMC-triage care model call-in/urgent care 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. Researchers will compare unplanned healthcare utilization, (the frequency of triage calls, MyChart messages, Urgent Care visits, ED visits, etc. related to urinary symptoms), between subjects in Self-Start arm (intervention) verses those who receive SMC.
Time frame
Day of procedure to 30-days post procedureSponsors and contacts
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Source ClinicalTrials.gov