Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07648290
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Subjects will received approved antibiotic for urinary tract infection — DRUG
    Subjects will be provided with an antibiotic to be taken once symptoms of urinary tract infection arise
  • Subjects will call the clinic if they have symptoms of a urinary tract infection — OTHER
    Subjects in the control group will call the clinic if they suspect that they have a urinary tract infection and will follow the routine nurse triage protocol for urinary tract infections

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Self-start Intervention
    Subjects will receive antibiotic prescription and sterile urine cup after procedure is completed
  • Active Comparator: Control Group
    Subjects will follow routine standard of care (notification of physician office) for urinary tract symptoms

Primary Outcome Measure

Healthcare utilization [ Time Frame: 30-days from procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Ugochukwu Okoroafor, MD
[email protected]
440-799-7739
Shannon Wallace, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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