Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms (NCT07648290) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
United States260 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Healthcare utilization
Timeframe: Day of procedure to 30-days post procedure