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

RecruitingEARLY Phase 1Ages 18 Years - anyFemaleThe Cleveland Clinic
NCT07648290 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 event

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📋 Eligibility rules (as published)
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.
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What it tests

  • Macrobid® Capsules 100 mg
  • Standard Medical Care (SMC)
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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