NCT07648290

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for early_phase_1

Timeline
21mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Healthcare utilization

    Telephone calls, urgent care visits, emergency department visits, in-person clinic appointments and MyChart messages will be recorded

    30-days from procedure

Study Arms (2)

Self-start Intervention

EXPERIMENTAL

Subjects will receive antibiotic prescription and sterile urine cup after procedure is completed

Drug: Subjects will received approved antibiotic for urinary tract infection

Control Group

ACTIVE COMPARATOR

Subjects will follow routine standard of care (notification of physician office) for urinary tract symptoms

Other: Subjects will call the clinic if they have symptoms of a urinary tract infection

Interventions

Subjects will received approved antibiotic for urinary tract infectionDRUG

Subjects will be provided with an antibiotic to be taken once symptoms of urinary tract infection arise

Self-start Intervention
Subjects will call the clinic if they have symptoms of a urinary tract infectionOTHER

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

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis is limited to females receiving intradetrusor botox for overactive bladder.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shannon Wallace, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ugochukwu Okoroafor, MD

CONTACT

440-799-7739okoroau@ccf.org

Shannon Wallace, MD

CONTACT

216-444-6878wallacs8@ccf.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 15, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)