260 Participants NeededMy employer runs this trial

Self-Start Triage Model for Overactive Bladder

UO
SW
Overseen ByShannon Wallace, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SW

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

I am a woman aged 18 or older.
Ability to navigate a computer system independently
Access to MyChart and email account
See 3 more

Exclusion Criteria

I am unable to understand or agree to participate in this study.
Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter
I have had severe kidney problems in the past.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure and Randomization

Participants undergo intradetrusor Botox® injection and are randomized into intervention or control groups

1 day
1 visit (in-person)

Intervention

Intervention group receives a standing prescription for Nitrofurantoin and instructions for urine sample collection; Control group follows standard triage line procedures

5-7 days

Follow-up

Participants are monitored for UTI symptoms and healthcare utilization from the day of procedure through 30 days post-procedure

30 days
Surveys on Day 7 and Day 30

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

Group I: Standard Triage Line; Standard Medical Care (SMC)Experimental Treatment1 Intervention
Group II: Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine CultureActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

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 ...

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 ...