Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cedars-Sinai Medical Center
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. The investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with OAB refractory to medical therapy.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Botox for treating overactive bladder?
Research shows that Botox (OnabotulinumtoxinA) is effective in managing overactive bladder, especially when other treatments haven't worked. Studies indicate it can help reduce symptoms, although some patients may experience side effects like difficulty urinating or urinary tract infections.
12345Is Botox safe for treating overactive bladder?
Research shows that Botox (onabotulinumtoxinA) is generally safe for treating overactive bladder, but some people may experience side effects like difficulty urinating, which might require using a catheter, and urinary tract infections.
34678How is the drug Botox different from other treatments for overactive bladder?
Botox (onabotulinumtoxinA) is unique because it is injected directly into the bladder muscle, helping to relax it and reduce symptoms of overactive bladder, especially when other treatments haven't worked. Unlike oral medications, Botox provides a localized effect and is often used when standard treatments are ineffective.
256910Eligibility Criteria
This trial is for women aged 21 or older who have overactive bladder symptoms that haven't improved with medication. Participants must be able to give informed consent and should not be claustrophobic, as the study involves MRI technology.Inclusion Criteria
I am 21 years old or older.
I am female.
Exclusion Criteria
I am under 21 years old.
I am unable to understand and agree to the study's details.
Participant Groups
The study tests how well botulinum toxin (Botox) works in treating overactive bladder when its effects are monitored using a special type of MRI called cineMRI combined with urodynamics. This aims to understand Botox's impact on bladder function.
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Botulinum toxin and cineMRI-UDS
Botulinum toxin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Botox for:
- Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
- Urinary incontinence due to detrusor overactivity associated with a neurologic condition
🇪🇺 Approved in European Union as Botox for:
- Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
- Urinary incontinence due to detrusor overactivity associated with a neurologic condition
🇨🇦 Approved in Canada as Botox for:
- Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
- Urinary incontinence due to detrusor overactivity associated with a neurologic condition
🇦🇺 Approved in Australia as Botox for:
- Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
- Urinary incontinence due to detrusor overactivity associated with a neurologic condition
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Cedars-Sinai Medical CenterBeverly Hills, CA
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Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
References
Randomized, double-blind, placebo controlled pilot study of intradetrusor injections of onabotulinumtoxinA for the treatment of refractory overactive bladder persisting following surgical management of benign prostatic hyperplasia. [2018]We assessed the efficacy of onabotulinumtoxinA (BOTOX, Allergan Inc., Irvine, CA, USA) in patients with refractory overactive bladder (OAB) after treatment for benign prostatic hyperplasia (BPH).
[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. [2019]Label="INTRODUCTION" NlmCategory="BACKGROUND">Since 2014, OnabotulinumtoxinA Botox® (Allergan, Inc., Irvine, USA) represents a new therapeutic option for second-line treatment of idiopathic overactive bladder. The purpose of the current study was to evaluate practices of surgeons using onabotulinium toxin (BoNTA) in this indication.
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).
Predictors of Poor Response and Adverse Events Following Botulinum Toxin A for Refractory Idiopathic Overactive Bladder: A Systematic Review. [2022]Botulinum toxin A (BTX-A) injections are effective in managing refractory overactive bladder (OAB). However, some patients exhibit a poor response and/or experience adverse events (AEs) such as voiding dysfunction necessitating clean intermittent self-catheterisation (CISC) and urinary tract infections (UTIs).
Perioperative Techniques for the Use of Botulinum Toxin in Overactive Bladder: Results of a Multinational Online Survey of Urogynecologists in Germany, Austria, and Switzerland. [2023]Botulinum toxin (BoNT) is a widely used treatment for overactive bladder (OAB). Despite its common use, no standardized treatment regimen exists so far. The aim of this survey was to evaluate the variation in perioperative treatment strategies among members of the German-speaking urogynecologic societies.
[Idiopathic overactive bladder and BOTOX(®): Literature review]. [2018]Systematically review literature on the efficacy and tolerability of botulinum toxin A (onabotulinumtoxineA, BOTOX(®), Allergan, CA, USA) in refractory idiopathic overactive bladder (iOAB) METHODS: Pubmed search on the efficacy, toxicity and adverse events of onabotulinumtoxinA in clinical trials only with level 1 and 2 evidence.
The safety and efficiency of onabotulinumtoxinA for the treatment of overactive bladder: a systematic review and meta-analysis. [2022]To assess the impact on safety and efficiency of onabotulinumtoxinA (BOTOX1, Allergan, Inc.) treatment in patients with an overactive bladder.
Predictive factors of adverse events after intravesical suburothelial onabotulinumtoxina injections for overactive bladder syndrome-A real-life practice of 290 cases in a single center. [2018]Patients often experience adverse events (AEs) after intravesical onabotulinumtoxinA (BoNT-A) treatment for overactive bladder refractory to antimuscarinic agents. We investigated the prevalence and predictive factors of AEs in such patients.
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.
Botulinum toxin injections for adults with overactive bladder syndrome. [2018]Overactive bladder syndrome is a common condition with a significant negative impact on quality of life. Intravesical injection of botulinum toxin is increasingly used as an intervention for refractory overactive bladder, with a considerable body of case reports and series in the literature suggesting beneficial effects.