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NOT YET RECRUITING
NCT07648290
EARLY_PHASE1

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-07-01

Completion Date

2028-03-31

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DRUG

Subjects will received approved antibiotic for urinary tract infection

Subjects will be provided with an antibiotic to be taken once symptoms of urinary tract infection arise

OTHER

Subjects will call the clinic if they have symptoms of a urinary tract infection

Subjects in the control group will call the clinic if they suspect that they have a urinary tract infection and will follow the routine nurse triage protocol for urinary tract infections

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States