Antibiotic Usage for Overactive Bladder

Recruiting at 1 trial location

Overseen By Justina Tam, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Benaroya Research Institute

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether people with overactive bladder (OAB) need antibiotics before receiving onabotulinumtoxinA injections, a common cystoscopic treatment. Typically, antibiotics are given to prevent urinary tract infections (UTIs) after the procedure. However, the study aims to determine if skipping antibiotics is safe for those without UTI symptoms. Participants should have OAB, have tried other unsuccessful treatments, and currently show no UTI symptoms. This research could reduce unnecessary antibiotic use and prevent related complications. As an unphased trial, it offers participants the chance to contribute to research that may lead to safer, more efficient treatment protocols.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use antibiotics within 48 hours before the procedure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that injecting onabotulinumtoxinA into the bladder is a safe and effective treatment for overactive bladder, particularly when other treatments have failed. Studies have found that many patients, including older adults, tolerate this treatment well. However, about 25% of patients may experience repeated urinary tract infections (UTIs) after the procedure.

A previous study found that patients with nerve-related bladder issues who did not take antibiotics did not have more UTIs after the procedure if they had no symptoms. This suggests that antibiotics might not always be necessary, helping to avoid side effects like diarrhea or antibiotic resistance from unnecessary use. Overall, the treatment appears safe for most people, but it is important to consider the risk of UTIs and weigh the pros and cons of using antibiotics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about testing the use of onabotulinumtoxinA, commonly known as Botox, for overactive bladder because it offers a unique approach compared to traditional options like anticholinergic medications or beta-3 adrenergic agonists. Unlike these standard treatments, which often work by relaxing bladder muscles through oral medication, onabotulinumtoxinA is directly injected into the bladder via cystoscopy, providing targeted muscle relaxation. This method may offer the advantage of reducing systemic side effects often associated with oral medications. Additionally, the trial is exploring the necessity of prophylactic antibiotics with this procedure, which could streamline patient care by potentially eliminating the need for antibiotics and reducing the risk of antibiotic resistance.

What evidence suggests that this trial's treatments could be effective for overactive bladder?

Research has shown that injecting onabotulinumtoxinA directly into the bladder can help people with overactive bladder (OAB) who don't respond to other treatments. This method significantly reduces the urgent and frequent need to urinate. For many patients, the effects last between 6 to 9 months. The FDA has approved this treatment for OAB, deeming it safe and effective. However, urinary tract infections (UTIs) are a common side effect. In this trial, one group of participants will receive prophylactic antibiotics before the procedure to help prevent UTIs, while another group will receive no antibiotics to evaluate the necessity of this practice. ^{1 2 4 5 6}

Who Is on the Research Team?

Justina Tam, MD

Principal Investigator

Stony Brook Medicine

Are You a Good Fit for This Trial?

Adults over 18 with an overactive bladder (OAB) who haven't improved with first and second-line treatments can join. They must not show symptoms or test positive for a urinary tract infection (UTI) at the time of treatment. Pregnant or breastfeeding women, recent antibiotic users, and those treated with high doses of onabotulinumtoxinA are excluded.

Inclusion Criteria

Age ≥ 18

You do not have symptoms of a urinary tract infection when you receive the injection.

Your urine test should not show signs of infection, and the number of white blood cells should be low.

Exclusion Criteria

Women who are pregnant or planning to become pregnant, women who are breastfeeding

You have taken antibiotics in the 48 hours before getting an injection of onabotulinumtoxinA into the bladder.

You have received more than 400 units of onabotulinumtoxinA injections within a 3-month period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intradetrusor injection of onabotulinumtoxinA with or without prophylactic antibiotics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the rate of symptomatic UTIs and adverse events

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• cystoscopic injection of onabotulinumtoxinA
• No antibiotic
• Prophylactic antibiotic

Trial Overview

The study is testing if giving antibiotics before injecting onabotulinumtoxinA into the bladder helps prevent UTIs in OAB patients without current infections. Participants will either receive a prophylactic antibiotic or no antibiotic before the procedure, to see which approach is better.

How Is the Trial Designed?

Group I: Prophylactic antibiotic Experimental Treatment 2 Interventions

These patients will receive the current standard of care, which is to receive a single dose of prophylactic antibiotics just prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy. The specific prophylactic antibiotics will vary depending on patient's prior urine culture sensitivities and patient medication allergies/sensitivities and medical comorbidities.

Group II: No antibiotics Experimental Treatment 2 Interventions

These patients will receive no prophylactic antibiotics prior to receiving intravesical injection of Onabotulinumtoxin A via cystoscopy.

cystoscopic injection of onabotulinumtoxinA is already approved in United States, European Union for the following indications:

Approved in United States as Botox for:

• Overactive bladder
• Urinary incontinence
• Neurogenic detrusor overactivity
• Chronic migraine
• Spasticity
• Cervical dystonia
• Axillary hyperhidrosis
• Blepharospasm
• Strabismus

Approved in European Union as Botox for:

• Overactive bladder
• Urinary incontinence
• Neurogenic detrusor overactivity
• Chronic migraine
• Spasticity
• Cervical dystonia
• Axillary hyperhidrosis
• Blepharospasm
• Strabismus

Who Is Running the Clinical Trial?

Benaroya Research Institute

Lead Sponsor

Trials

50

Recruited

12,300+

Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

Collaborator

Trials

7

Recruited

360+

Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)

Collaborator

Trials

1

Recruited

200+

Stony Brook University

Collaborator

Trials

225

Recruited

41,700+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Virginia Mason Hospital/Medical Center

Collaborator

Trials

23

Recruited

8,500+

Published Research Related to This Trial

A systematic review of 27 studies involving 2,100 patients indicated that prophylactic antibiotics are beneficial in reducing urinary tract infections (UTIs) after onabotulinum toxin type A (BTX) injections for overactive bladder syndrome, particularly in patients with idiopathic OAB.

The analysis suggests that continuing antibiotics for 2-3 days post-injection may help prevent UTIs, although no specific antibiotic regimen was identified as optimal due to the variability in the data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis for onabotulinum toxin A injections: systematic review and meta-analysis. Getaneh, FW., Simhal, R., Sholklapper, T., et al.[2023]

In a study of 284 patients receiving intravesical Botox® for detrusor overactivity, those who took a 3-day course of oral fluoroquinolone antibiotics had a significantly lower rate of urinary tract infections (UTIs) at 20.8% compared to 36% in those who received a single intramuscular dose of ceftriaxone.

The findings suggest that a longer course of antibiotics, especially for patients with a positive preprocedure urine culture, may further reduce the risk of postprocedure UTIs following Botox® injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Houman, J., Moradzadeh, A., Patel, DN., et al.[2020]

In a study of 174 patients receiving a single intravesical injection of 100U onabotulinumtoxinA for idiopathic detrusor overactivity, 79.3% reported successful outcomes at 3 months, indicating the treatment's efficacy.

Despite common adverse events like acute urinary retention and large postvoid residual, these did not negatively impact the long-term therapeutic success rates, suggesting that the treatment remains effective even in the presence of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficult Urination Does Not Affect the Successful Outcome after 100U OnabotulinumtoxinA Intravesical Injection in Patients with Idiopathic Detrusor Overactivity. Chen, YC., Kuo, HC.[2015]

In a study of 616 procedures involving intravesical botulinum toxin A (BoNTA) injections for detrusor overactivity in patients with spinal cord injury, only 1.8% developed symptomatic urinary tract infections (UTIs), suggesting that the procedure is relatively safe.

The findings indicate that a single dose of antibiotics prior to the BoNTA injection is sufficient to prevent UTIs, challenging the need for prolonged antibiotic prophylaxis, although further randomized clinical trials are needed for confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different antibiotic protocols for asymptomatic bacteriuria in patients with neurogenic bladder treated with botulinum toxin A. Paradella, AC., Musegante, AF., Brites, C.[2022]

In a study of 565 women undergoing Botox treatment for overactive bladder, 92.9% received some form of antibiotic prophylaxis, yet this did not significantly reduce the incidence of urinary tract infections (UTIs) post-procedure, with a UTI rate of 30.4%.

No specific route of antibiotic administration (IV, oral, or combination) was found to be more effective than no prophylaxis at preventing UTIs, suggesting that current prophylactic practices may need reevaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic regimen and route of administration do not alter rates of urinary tract infection after intravesical botulinum toxin injection for overactive bladder. Eckhardt, SE., Takashima, Y., Handler, SJ., et al.[2022]

In a study of 216 patients receiving onabotulinumtoxin A (BTX-A) for overactive bladder, only 8.3% of patients in the operating room received antibiotics that matched the American Urological Association's 2008 guidelines, compared to 82% in the office setting, indicating significant variability in antibiotic practices.

The rates of urinary tract infections (UTIs) within 30 days post-BTX-A injection did not significantly differ based on whether the antibiotics used were concordant with the guidelines, suggesting that adherence to these antibiotic recommendations may not impact UTI rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic use, best practice statement adherence, and UTI rate for intradetrusor onabotulinumtoxin-A injection for overactive bladder: A multi-institutional collaboration from the SUFU Research Network (SURN). Shapiro, K., Anger, J., Cameron, AP., et al.[2023]

In a study of 208 women with idiopathic overactive bladder (OAB) treated with 100 U of Botox, older and multiparous women were found to be at a higher risk for urinary retention, particularly those requiring clean intermittent self-catheterization (CISC).

The risk of urinary retention significantly decreased by 2 weeks post-injection, indicating that close monitoring during this period is crucial for OAB patients after receiving Botox treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary retention in female OAB after intravesical Botox injection: who is really at risk? Miotla, P., Cartwright, R., Skorupska, K., et al.[2018]

In a study involving 62 patients with overactive bladder, a single instillation of liposomal botulinum toxin significantly reduced micturition events and urinary urgency compared to a placebo, indicating its efficacy in managing symptoms.

Importantly, this treatment did not increase the risk of urinary retention, suggesting it may be a safer alternative to traditional botulinum toxin injections for patients with refractory overactive bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial. Chuang, YC., Kaufmann, JH., Chancellor, DD., et al.[2022]

In a study of 102 women, both those with idiopathic overactive bladder (OAB) and those with de novo OAB after midurethral sling surgery showed significant improvement in symptoms after receiving onabotulinumtoxinA injections, with similar rates of being completely dry (41.5% vs. 38.8%).

The treatment led to a notable reduction in daily voids and incontinence episodes for both groups, with urinary retention occurring in only four patients, indicating that the safety profile of onabotulinumtoxinA is acceptable even in women who have undergone previous surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery. Miotla, P., Futyma, K., Cartwright, R., et al.[2018]

In a study of 281 women undergoing onabotulinumtoxinA injections for urgency incontinence, using multiple doses of prophylactic antibiotics did not significantly reduce the rate of urinary tract infections compared to a single dose, with infection rates of 13.8% and 10.3% respectively.

The study found that having a positive urine culture within 30 days post-injection greatly increased the odds of developing a urinary tract infection, highlighting the importance of monitoring urine cultures in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary tract infection following intradetrusor onabotulinumtoxina injection for non-neurogenic urgency incontinence: single- vs. multi-dose prophylactic antibiotic treatment regimens. Crouss, T., Kim, Y., Lai, E., et al.[2023]

Botulinum toxin-A significantly improves symptoms of idiopathic overactive bladder (OAB), including reduced urinary frequency and incontinence episodes, based on a review of 12 randomized controlled trials involving 1,020 participants.

While effective, botulinum toxin-A is associated with a higher risk of urinary retention and urinary tract infections compared to placebo, suggesting that lower doses may provide a better balance of benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin-A injections for idiopathic overactive bladder: a systematic review and meta-analysis. Cui, Y., Wang, L., Liu, L., et al.[2022]

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16 year's experience of a Tertiary Centre in the UK

52% of patients were lost to follow-up and 30% are ongoing patients. Recurrent UTIs developed in 23%. Conclusion: Repeated Botox injections appear to be a safe ...

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