Home › Overactive Bladder › NCT07648290
Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
About the study
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.
What is being tested
- Macrobid® Capsules 100 mg (drug)
- Standard Medical Care (SMC) (other)
Sponsor: The Cleveland Clinic · Participants: 260 · Started: Jul 31, 2026
Contact the study team
- Ugochukwu Okoroafor, MD · Phone: 440-799-7739
- Shannon Wallace, MD · Phone: 216-444-6878
Official record on ClinicalTrials.gov — NCT07648290
Locations in the U.S.
| Ohio | Cleveland Clinic, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.