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

Recruiting now · Early Phase 1

Conditions studied: Overactive Bladder

In brief

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 facts

Study ID

NCT07648290

Run by

The Cleveland Clinic

People needed

260

Starts

2026-07-31

Expected to finish

2028-03-31

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Active UTI at the time of procedure (procedure cancellation criteria).
• Patients currently on prophylactic antibiotics.
• Inability to provide informed consent.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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