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

NCT07648290 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 26-430
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Healthcare utilization

  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 will compare unplanned healthcare utilization, (the frequency of triage calls, MyChart messages, Urgent Care visits, ED visits, etc. related to urinary symptoms), between subjects in Self-Start arm (intervention) verses those who receive SMC.

  Day of procedure to 30-days post procedure

Study Arms (2)

Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture

ACTIVE COMPARATOR

Following the procedure, subjects 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 standing lab orders for urine culture and discharge instructions. Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.

Drug: Macrobid® Capsules 100 mg

Standard Triage Line; Standard Medical Care (SMC)

OTHER

Subjects 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.

Other: Standard Medical Care (SMC)

Interventions

Macrobid® Capsules 100 mg DRUG

Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture. Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.

Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture

Standard Medical Care (SMC) OTHER

Subjects will receive standard of care post-procedure discharge instructions which instruct the following if a urinary tract infection is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic.

Standard Triage Line; Standard Medical Care (SMC)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is limited to females receiving intradetrusor botox for overactive bladder.
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shannon Wallace, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ugochukwu Okoroafor, MD

CONTACT

440-799-7739; okoroau@ccf.org

Shannon Wallace, MD

CONTACT

216-444-6878; wallacs8@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: July 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)