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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: Clinical Trial Early Phase 1 study, sponsored by The Cleveland Clinic.
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, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (391% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 w
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 |
What is known before NCT07648290 opens enrollment
NCT07648290 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (391% higher).
The record links to 0 conditions, and to 2 interventions - of which Standard Medical Care (SMC) is the first listed.
NCT07648290 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07648290's enrollment target sits among peer trials
260 43rd of 2000 higher than 1,958 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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