What side effects are associated with this type of intervention?

Common treatments for Overactive Bladder (OAB) include anticholinergics, beta-3 adrenergic agonists, and antibiotics like Ciprofloxacin. Anticholinergics can cause dry mouth, constipation, blurred vision, and urinary retention. Beta-3 adrenergic agonists may lead to increased blood pressure and headache. Ciprofloxacin, an antibiotic, can cause gastrointestinal disturbances, such as nausea and diarrhea, as well as potential tendonitis and increased risk of tendon rupture. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Overactive Bladder (OAB), primarily focusing on antimuscarinics and beta-3 adrenergic agonists. Commonly approved drugs include oxybutynin, tolterodine, solifenacin, and mirabegron. These medications work by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. While Ciprofloxacin is an antibiotic used to prevent postoperative bladder infections, it is not typically used for the direct treatment of OAB. Instead, it may be used prophylactically in procedures related to bladder treatments to prevent infections.

What other types of research exist?

Promising alternatives to Ciprofloxacin for preventing postoperative bladder infections in overactive bladder patients include fosfomycin and antibiotic-coated implants. These options are effective against multi-resistant organisms and may offer a safer profile given the concerns about fluoroquinolone resistance and safety.

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Antibiotics for Overactive Bladder Post-Botox

Phase 4

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2 and 6 weeks following the procedure

Awards & highlights

All Individual Drugs Already Approved

Approved for 40 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing if taking antibiotics right after Botox injections in the bladder can prevent infections in women with overactive bladder. The goal is to see if antibiotics reduce the risk of bladder infections after the procedure. Botox A was approved by the U.S. Food and Drug Administration for the treatment of overactive bladder.

Who is the study for?

This trial is for women over 18 with an overactive bladder (OAB) that hasn't improved with medication. It's not for those under 18, pregnant or breastfeeding, men, anyone allergic to Botox or Ciprofloxacin, currently have a UTI or can't empty their bladder fully.

What is being tested?

The study tests if taking the antibiotic Ciprofloxacin after getting Botox injections in the bladder reduces infections compared to a placebo pill. Women are randomly assigned to one of these two groups and followed up for six weeks.

What are the potential side effects?

Possible side effects include reactions related to antibiotics like stomach upset, rash, and yeast infections. There may also be typical Botox injection issues such as pain at the injection site or difficulty urinating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2 and 6 weeks following the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 2 and 6 weeks following the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2 and 6 weeks following the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Postoperative Urinary Tract Infection

Secondary study objectives

Rate of Other Adverse Events

Rate of Postoperative Urinary Tract Infection Rate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 40 Other Conditions

This treatment demonstrated efficacy for 40 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment ArmActive Control1 Intervention

Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure

Group II: Placebo ArmPlacebo Group1 Intervention

Placebo pill PO every 12 hrs for 3 days following the procedure

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Overactive Bladder (OAB) include anticholinergics and beta-3 adrenergic agonists. Anticholinergics work by blocking acetylcholine receptors in the bladder, which reduces involuntary contractions and helps increase bladder capacity. Beta-3 adrenergic agonists relax the bladder muscle by stimulating beta-3 receptors, also increasing bladder capacity and reducing urgency and frequency of urination. These treatments are crucial for OAB patients as they directly address the symptoms of urgency, frequency, and incontinence, significantly improving quality of life.