Recruiting
Early Phase 1

Macrobid

Sponsor:

The Cleveland Clinic

Code:

NCT07648290

Conditions

Overactive Bladder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Macrobid® Capsules 100 mg

Standard Medical Care (SMC)

Study Details

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

Study ID

NCT07648290

Start date

Jul 31, 2026

Status verified date

Jul, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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.

other: Standard Triage Line; Standard Medical Care (SMC)

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.

Interventions

Macrobid® Capsules 100 mg

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.

Standard Medical Care (SMC)

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.

Primary outcome measure

  • Healthcare utilization [ Time Frame: Day of procedure to 30-days post procedure ]

Central Contacts and Locations

Central contacts

Ugochukwu Okoroafor, MD

440-799-7739okoroau@ccf.org

Shannon Wallace, MD

216-444-6878wallacs8@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ugochukwu Okoroafor, MD

440-799-7739okoroau@ccf.org

Principal Investigator:

Shannon Wallace, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-03.