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NCT07648290 · ClinicalTrials.gov registry record · Early Phase 1
Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
A Early Phase 1 study, sponsored by The Cleveland Clinic.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 260
- Enrollment target
NCT07648290 is a Early Phase 1 study that has not yet begun recruiting, run by The Cleveland Clinic. The registered enrollment target is 260 participants.
The verdict
NCT07648290, a Early Phase 1 study, has not yet begun recruiting, sponsored by The Cleveland Clinic.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 260 participants
- Enrollment target
Study 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.
Interventions
- OTHER Standard Medical Care (SMC)
- DRUG Macrobid® Capsules 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-03-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07648290
The ClinicalTrials.gov registry entry for NCT07648290 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Medical Care (SMC) is the first listed.
NCT07648290 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07648290 about?
NCT07648290 is a clinical study titled "Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms". 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 th...
What is the current status of trial NCT07648290?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 260 participants. The study started on 2026-07-01. Estimated completion is 2028-03-31.
What interventions are being tested in trial NCT07648290?
The interventions under investigation include: Standard Medical Care (SMC) (OTHER), Macrobid® Capsules 100 mg (DRUG).
Who is sponsoring clinical trial NCT07648290?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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