NCT07648290 · The Cleveland Clinic
Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Macrobid® Capsules 100 mg
Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture. Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.
OTHER
Standard Medical Care (SMC)
Subjects will receive standard of care post-procedure discharge instructions which instruct the following if a urinary tract infection is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic.
Primary outcome measures
Healthcare utilization
Time frame: Day 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cleveland, Ohio
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations