drugset / Trial / NCT07648290

Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms

NCT07648290

Phase 0 Not yet recruiting 260 enrolled The Cleveland Clinic
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2026-07-01
Primary completion
2028-03-31
Completion
2028-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitrofurantoin Unknown 100 mg Oral

Indications