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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Subjects will received approved antibiotic for urinary tract infection; Other: Subjects will call the clinic if they have symptoms of a urinary tract infection

Detailed Description

Study Procedure and Intervention

Following enrollment and consent, participants will be randomized into two groups allocated 1:1 as follows:

• Intervention Group: Standing Prescription (Self-Start) + Sterile Urine Cup
• Control Group: Standard Triage Line.

Provider stratified block randomization (block size 4) will be implemented by REDCap randomization module on the day of participants scheduled procedure. At this point, each participant will be given a unique Study ID number to allow study coordinators to commence data abstraction from the EMR (EPIC) into REDCap.

All participants, regardless of randomization, will follow the current practice with provider specific antibiotic prophylaxis protocol as prescribed. Electronic medical record review will be performed by the study investigators to obtain relevant medical history, treatment plan and demographic information for each participant and transcribed into REDCap.

Arm 1: Intervention Group Following the procedure, participants will receive a standing prescription for oral Nitrofurantoin (Macrobid) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and discharge instructions. International treatment guidelines recommend short-course regimens for acute uncomplicated cystitis, usually 3-6 days of antibiotic therapy. This is supported by a Cochrane review of 15 studies, including 1644 elderly women, showing non-inferiority of short course regimen to a 7-14-day long course for treating uncomplicated cystitis in elderly women.

Participants will be provided with standard procedural discharge instructions. The standard procedural discharge instructions will be modified to include instructions on taking antibiotics as part of the study. A section for how to collect a sterile urine sample will also be included with their discharge instructions.

Participants will be instructed that if they experience specific UTI symptoms, they must:

• Collect a clean-catch midstream urine sample in the provided cup.
• Drop the sample at a Cleveland Clinic lab facility (a standing order for urine culture will be placed in the EMR).
• Initiate the antibiotic prescription after dropping off the sample.

UTI Symptoms are defined as dysuria, urinary frequency, urinary urgency and suprapubic pain. Participants with fever ≥100.4°F, flank pain, chills, or systemic symptoms will be instructed to seek immediate medical care and not self-start antibiotics. A member of the study team will monitor the results of the urine cultures for the intervention group. If a culture confirms a pathogen resistant to Macrobid, the participant will be contacted by a member of the team to discontinue Macrobid and initiate appropriate antibiotic therapy.

Arm 2: Control Group Participants will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic. Subsequent interactions with participants in control groups needing intervention (i.e UTI needing antibiotics) will be managed in relation to how care is sought. The research team will only observe participants' interactions with the health care system.

Follow-Up Participants will be monitored from the time of intradetrusor Botox® injection through 30 days post-procedure, corresponding to the highest risk window for post-procedural UTI and urinary retention.

Data collection will include:

• Survey assessment on Day 7 for possible symptoms of UTI and symptoms severity using Patient Global Impression of Severity (PGI-S)
• Survey assessment on Day 30 for possible symptoms of UTI, and symptoms severity using PGI-S and treatment satisfaction.
• EMR review for unscheduled UTI related visits or antibiotic prescriptions

• Telephone or secure MyChart portal messages.

  7-days after the procedure is performed, each participant will receive the initial automated REDCap survey to assess for possible symptoms of a UTI and severity of symptoms using the Patient Global Impression of Severity (PGI-S). Symptoms of UTIs are defined as dysuria, urgency, suprapubic pain, fever and flank pain. Also included in the survey assessment with be two additional questions regarding timeline of symptoms and treatment initiation. This survey is easy to follow and will take no more than 5 minutes to complete.

At the end of the 30-day period, all participants will receive two surveys via automated REDCap to again assess for symptoms of UTI and severity using the PGI-S, and their level of satisfaction with their post-procedure care. Both surveys will take no more than 5 minutes to complete. Reminder emails to complete the surveys will be sent to participants no more than 2 times. Individual responses will be linked to the participants' unique ID number. All the data collection will be performed by the study investigators through electronic medical record review and stored in REDCap for up to 6 years after study closure.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ugochukwu Okoroafor, MD; Phone Number: 440-799-7739; Email: okoroau@ccf.org
• Study Contact Backup: Name: Shannon Wallace, MD; Phone Number: 216-444-6878; Email: wallacs8@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
      • Contact: Ugochukwu Okoroafor, MD; Phone Number: 440-799-7739; Email: okoroau@ccf.org
      • Principal Investigator: Shannon Wallace, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-start Intervention; Subjects will receive antibiotic prescription and sterile urine cup after procedure is completed	Drug: Subjects will received approved antibiotic for urinary tract infection; Subjects will be provided with an antibiotic to be taken once symptoms of urinary tract infection arise
Active Comparator: Control Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization	Telephone calls, urgent care visits, emergency department visits, in-person clinic appointments and MyChart messages will be recorded	30-days from procedure

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Shannon Wallace, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive
• Other Study ID Numbers: 26-430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No