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NCT07648290

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalSupportive care
The Cleveland Clinic
~260 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Macrobid® Capsules 100 mgStandard Medical Care (SMC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Healthcare utilization
Measured over Day of procedure to 30-days post procedure

Conditions

Overactive Bladder

Explore related trials

Overactive BladderUrge incontinence of urine

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Shannon Wallace, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Ugochukwu Okoroafor, MD
[email protected]
440-799-7739
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Healthcare utilizationDay of procedure to 30-days post procedure

    Investigate whether providing a standing, take-home prescription for Nitrofurantoin (MACROBID), or other suitable prescription alternate detailed in the "arms and interventions section", is superior to SMC-triage care model call-in/urgent care 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. Researchers will compare unplanned healthcare utilization, (the frequency of triage calls, MyChart messages, Urgent Care visits, ED visits, etc. related to urinary symptoms), between subjects in Self-Start arm (intervention) verses those who receive SMC.