Self-Start Macrobid for post-Botox lower urinary symptoms
Official title: Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
Run by The Cleveland Clinic · NCT07648290 · Data updated 2026-11-12
This study tests whether giving a standing prescription for Macrobid after Botox treatment reduces urgent calls, messages, and visits for urinary symptoms compared with usual triage care.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 260 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | July 31, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07648290 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 and older with overactive bladder or urge urinary incontinence scheduled for intradetrusor Botox who use MyChart/email and can navigate a computer.
✕Probably not a fit
Patients who develop or have recurrent UTIs, renal impairment, or other exclusion criteria may not benefit from the self-start approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with overactive bladder undergoing intradetrusor Botox will be randomized to receive a standing antibiotic prescription for five days plus a urine cup, versus standard triage care. The goal is to see if the self-start approach lowers unplanned healthcare utilization related to urinary symptoms. All participants will follow the existing antibiotic prophylaxis protocol, and data will be collected from medical records. The trial is conducted at The Cleveland Clinic and is sponsored by Cleveland Clinic.
Why it matters
Potential benefit: If successful, patients may experience fewer urgent healthcare contacts and visits related to urinary symptoms after Botox treatment.
How similar studies have gone: Previous short-course antibiotic strategies for uncomplicated UTIs have shown non-inferiority to longer courses in broader populations; this study applies that concept to post-Botox care.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Shannon Wallace, MD — The Cleveland Clinic
- Study coordinator: Ugochukwu Okoroafor, MD
- Email: okoroau@ccf.org
- Phone: 440-799-7739
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.