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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

260 Participants
are divided into 2 treatment groups

Sponsors and collaborators