Clinical Trial

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

Recruiting Early Phase 1
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-04
Trial Details
NCT Number NCT07648290
Lead Sponsor The Cleveland Clinic
Conditions Overactive Bladder
Enrollment 260 participants
Start Date 2026-07-31
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-03