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

  • 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.
  • 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.

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

First listed
Jun 15, 2026
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

  • 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.

Primary Outcome Measure

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