Antibiotic Usage for Overactive Bladder
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Benaroya Research Institute
Must not be taking: Antibiotics
Disqualifiers: Pregnancy, Breastfeeding, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysis and are not symptomatic for UTI and receive prophylactic antibiotics at the time of intradetrusor onabotulinumtoxinA injection compared to those who do not receive prophylactic antibiotics at the time of injection. The proposed study seeks to evaluate the current practice standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
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.
What data supports the effectiveness of the drug onabotulinumtoxinA for treating overactive bladder?
Research shows that onabotulinumtoxinA (Botox) injections are effective in treating symptoms of overactive bladder, including those that occur after certain surgeries. However, there is a risk of urinary tract infections and urinary retention, which are complications that need to be managed.
12345Is onabotulinumtoxinA (Botox) safe for treating overactive bladder?
OnabotulinumtoxinA (Botox) is generally considered safe for treating overactive bladder, but it can increase the risk of urinary tract infections and urinary retention (difficulty emptying the bladder).
12467How is the drug onabotulinumtoxinA (Botox) used for overactive bladder different from other treatments?
OnabotulinumtoxinA (Botox) is unique for overactive bladder treatment because it is injected directly into the bladder muscle, helping to relax it and reduce symptoms, unlike oral medications that work systemically. This localized approach can be beneficial for patients who do not respond well to standard oral treatments.
1891011Eligibility Criteria
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.Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Prophylactic antibioticExperimental Treatment2 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 antibioticsExperimental Treatment2 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Stony Brook MedicineStony Brook, NY
Vriginia Mason Medical CenterSeattle, WA
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Who is running the clinical trial?
Benaroya Research InstituteLead Sponsor
Society of Urodynamics, Female Pelvic Medicine & Urogenital ReconstructionCollaborator
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)Collaborator
Stony Brook UniversityCollaborator
Northwell HealthCollaborator
Virginia Mason Hospital/Medical CenterCollaborator
References
What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. [2020]Onabotulinum toxin A (Botox®) administered intravescially is an effective treatment for idiopathic detrusor overactivity, of which urinary tract infections (UTIs) are a common complication. The purpose of this study was to compare two prophylactic antibiotic regimens with the goal of decreasing UTI rates following intravesically administered Botox® injection.
Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial. [2022]Cystoscopic intradetrusor injection of botulinum toxin has helped patients with refractory overactive bladder but with the increased risks of urinary tract infection and urinary retention. We assessed whether catheter instillation of 200 U onabotulinumtoxinA formulated with liposomes is safe and effective for the treatment of overactive bladder.
Urinary retention in female OAB after intravesical Botox injection: who is really at risk? [2018]Intravesical onabotulinumtoxinA (Botox) injections are effective for the treatment of idiopathic overactive bladder (OAB) symptoms. The aim of our study was to assess the predisposing factors for urinary retention in women with OAB after intravesical Botox injection.
Difficult Urination Does Not Affect the Successful Outcome after 100U OnabotulinumtoxinA Intravesical Injection in Patients with Idiopathic Detrusor Overactivity. [2015]Intravesical injection of onabotulinumtoxinA (i.e. Botox) provides effective treatment for overactive bladder. However, treatment-related adverse events (AEs) remain problems. This study investigated the effect of AEs after onabotulinumtoxinA injection on the success rate for idiopathic detrusor overactivity (IDO).
Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery. [2018]Intravesical onabotulinumtoxinA (Botox®) is effective for idiopathic overactive bladder (OAB) symptoms. Our primary objective was to compare the efficacy of onabotulinumtoxinA for women with de novo OAB after midurethral sling (MUS) surgery and women with idiopathic OAB.
Urinary tract infection following intradetrusor onabotulinumtoxina injection for non-neurogenic urgency incontinence: single- vs. multi-dose prophylactic antibiotic treatment regimens. [2023]Urinary tract infection is one of the most common adverse events following onabotulinumtoxinA injection for urgency incontinence. Our hypothesis was that those undergoing injection for urgency incontinence who received more than one dose of prophylactic antibiotics have lower post-procedure urinary tract infection rates compared to those who receive a single dose.
Botulinum toxin-A injections for idiopathic overactive bladder: a systematic review and meta-analysis. [2022]To review the current evidence on the efficacy and safety of botulinum toxin-A in the management of idiopathic overactive bladder (OAB).
Antibiotic regimen and route of administration do not alter rates of urinary tract infection after intravesical botulinum toxin injection for overactive bladder. [2022]Guidelines vary on antibiotic prophylaxis for onabotulinumtoxinA (Botox) treatment for overactive bladder (OAB). Our primary objective was to determine whether any prophylactic regimen is more effective in preventing urinary tract infection (UTI) after Botox. The secondary objective was to identify prophylactic practice patterns among female pelvic medicine and reconstructive surgery (FPMRS) providers of different training backgrounds as well as general urologists.
Antibiotic prophylaxis for onabotulinum toxin A injections: systematic review and meta-analysis. [2023]To our knowledge, there are no evidence-based recommendations regarding the optimal prophylactic antibiotic regimen for intradetrusor onabotulinum toxin type A (BTX) injections. This systematic review and meta-analysis was aimed at investigating the optimal prophylactic antibiotic regimen to decrease urinary tract infection (UTI) in patients undergoing BTX for overactive bladder syndrome (OAB).
Comparison of different antibiotic protocols for asymptomatic bacteriuria in patients with neurogenic bladder treated with botulinum toxin A. [2022]Intravesical botulinum toxin A (BoNTA) injection has been widely used for the treatment of detrusor overactivity in patients with neurogenic bladder due to spinal cord injury who do not respond to conventional treatment. There is no consensus about antibiotic prophylaxis for this procedure. We conducted a retrospective analysis of medical records of adult patients with spinal cord injury who underwent detrusor BoNTA injection between January of 2007 and December of 2013 in a rehabilitation hospital. Occurrence of symptomatic urinary tract infection (UTI) was assessed in 3 groups in accordance with their use of antibiotics (prophylactic dosage, 3 days, more than 3 days) for the treatment of asymptomatic bacteriuria. All patients were performing self or assisted clean intermittent bladder catheterization and underwent a rigid cystoscopy, under general or regional anesthesia with sedation, and the drug used was Botox®. A total of 616 procedures were performed during the study period. There were 11 identified cases of UTI (1.8%) with a trend to a higher rate in the group that used antibiotics for longer time. This report shows that a single dose of antibiotics before the detrusor BoNTA injection is enough to prevent UTI. Randomized clinical trial should be conducted for definitive conclusions.
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). [2023]Onabotulinumtoxin A (BTX-A) is a well-established treatment for overactive bladder (OAB). The American Urological Association (AUA) 2008 Antibiotic Best Practice Statement (BPS) recommended trimethoprim-sulfamethoxazole or fluoroquinolone for cystoscopy with manipulation. The aim of the study was to evaluate concordance with antibiotic best practices at the time of BTX-A injection and urinary tract infection (UTI) rates based on antibiotic regimen.