Self-Start Triage Model for Overactive Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the best ways to manage urinary tract infections (UTIs) in individuals receiving Botox® for overactive bladder. The study compares two approaches: one where patients receive a take-home prescription to start treatment if they suspect a UTI, and another where they must first contact a healthcare provider. The goal is to determine if the self-start method reduces urgent healthcare visits. Suitable candidates for this trial have an overactive bladder, are scheduled for Botox® treatment, and have access to email and MyChart for communication with healthcare providers. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are currently on prophylactic antibiotics, you would not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Nitrofurantoin, the main treatment in this trial, is generally safe for treating urinary tract infections (UTIs). Studies have found it effective for many sudden urinary infections, with most patients tolerating it well.
Nitrofurantoin may cause minor side effects like nausea or headache, but these are usually manageable. Importantly, long-term use of Nitrofurantoin carries a low risk of serious side effects or antibiotic resistance.
Overall, Nitrofurantoin is a widely used and trusted antibiotic for UTIs, approved by the FDA for this purpose. This approval indicates a strong safety profile for most people, especially when used as directed.12345Why are researchers excited about this trial?
Researchers are excited about the Self-Start Triage Model for overactive bladder because it offers a proactive approach to managing urinary tract infections (UTIs). Unlike standard care, which requires patients to contact healthcare providers or visit clinics when symptoms appear, this model empowers patients to start treatment immediately with a standing prescription for Nitrofurantoin or other suitable antibiotics. This method could significantly reduce the time to treatment, potentially improving patient outcomes and reducing the burden on healthcare systems. By allowing patients to self-initiate treatment, this approach may streamline care and offer more timely relief from symptoms.
What evidence suggests that the self-start triage model is effective for reducing unplanned healthcare utilization in patients with overactive bladder?
In this trial, participants in one arm will receive a standing prescription for Nitrofurantoin, commonly known as Macrobid, as part of a self-start triage model for overactive bladder. Research has shown that Nitrofurantoin effectively treats urinary tract infections (UTIs). One study found that 70% of women taking Nitrofurantoin experienced complete relief from UTI symptoms, compared to 58% who used a different antibiotic. A review of 12 studies confirmed that Nitrofurantoin is as effective as other long-term antibiotics in preventing recurring UTIs. It is often preferred over antibiotics like Ciprofloxacin for simple UTIs due to its safety profile, low risk of side effects, and minimal potential for developing antibiotic resistance.16789
Who Is on the Research Team?
Shannon Wallace, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for people with overactive bladder who are getting Botox® injections in their bladder. Participants must be at risk for urinary tract infections after the procedure and able to follow instructions about when to take antibiotics or contact the clinic.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure and Randomization
Participants undergo intradetrusor Botox® injection and are randomized into intervention or control groups
Intervention
Intervention group receives a standing prescription for Nitrofurantoin and instructions for urine sample collection; Control group follows standard triage line procedures
Follow-up
Participants are monitored for UTI symptoms and healthcare utilization from the day of procedure through 30 days post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- Macrobid (Nitrofurantoin)
Trial Overview
The study compares two ways of managing possible urinary tract infections after bladder Botox®. One group gets a prescription to start antibiotics themselves if symptoms appear, while the other follows standard care by calling the clinic if they have symptoms.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Citations
Nitrofurantoin: properties and potential in treatment of urinary ...
It can be concluded from this review that NF can be considered as the most effective drug in the treatment of acute urinary infection, but due to the long-term ...
Macrobid vs. Cipro for UTIs: The Differences Between Two ...
Macrobid and Cipro are antibiotics commonly used to treat UTIs. In most cases, Macrobid is preferred over Cipro. Learn more about these UTI ...
3.
evidence.nihr.ac.uk
evidence.nihr.ac.uk/alert/nitrofurantoin-is-as-effective-as-other-long-term-antibiotics-for-preventing-recurrent-urinary-tract-infections/Nitrofurantoin is as effective as other long-term antibiotics ...
The analysis of 12 trials found no difference in successful cure of urinary tract infections in adult women with recurrent urinary tract ...
Support for nitrofurantoin in uncomplicated urinary tract ...
After 28 days, 70% of the women in the nitrofurantoin group and 58% in the fosfomycin group reported a complete resolution of symptoms (P<0.004) ...
safety and efficacy of prolonged nitrofurantoin suppressive ...
We found that prolonged NF suppressive therapy is well-tolerated with minimal risk of adverse events or development of antibiotic resistance.
Nitrofurantoin (oral route) - Side effects & dosage
Nitrofurantoin is used to treat urinary tract infections. This medicine is an antibiotic. It works by killing bacteria or preventing their growth.
Still in pain? Why your bladder is still burning on Nitrofurantoin ...
1. The Infection May Be Resistant to Nitrofurantoin · 2. It May Not Be a Simple Bladder Infection · 3. The Infection May Have Spread to the ...
When should you avoid nitrofurantoin?
1. When there is no need for treatment or prophylaxis · 2. When there is documented nitrofurantoin resistance · 3. When the creatinine clearance is below 30 mL/ ...
Spotlight on nitrofurantoin
Antimicrobial susceptibility data from New Zealand hospital and community laboratories indicate most urinary E. coli infections are susceptible ...
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