Botox for Overactive Bladder

Overseen By Jennifer Anger, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Age under 21, Claustrophobic, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Botox can assist women with overactive bladder (OAB) who haven't found success with standard treatments. Researchers use special imaging (cine MRI) and bladder tests (urodynamics) to observe Botox's effects on the bladder. Women aged 21 or older experiencing OAB symptoms may qualify to participate. As an unphased trial, this study offers participants an opportunity to contribute to groundbreaking research and potentially find relief from OAB symptoms.

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 prior data suggests that this method is safe for treating overactive bladder?

Studies have shown that using botulinum toxin to treat overactive bladder is generally safe, but some side effects require attention. Research indicates that urinary tract infections (UTIs) are among the most common side effects. About 18% of those who received the treatment reported UTIs, compared to 6% who received a placebo.

Another study found that repeated Botox injections for this condition are safe over the long term. However, it also found that UTIs affected about 1 in 4 women who received the treatment. Other side effects can include discomfort while urinating, known as dysuria.

While botulinum toxin is approved for other uses, these findings underscore the importance of being aware of potential side effects when considering this treatment for an overactive bladder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Botox, known scientifically as botulinum toxin, for treating overactive bladder because it offers a unique approach compared to traditional treatments like anticholinergic medications. While most current treatments work by blocking certain nerve signals to the bladder, Botox is directly injected into the bladder muscle, where it temporarily paralyzes the muscle to prevent involuntary contractions. This mechanism can provide relief for patients who don't respond well to oral medications and may offer a longer-lasting effect, reducing the need for daily pills.

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

Studies have shown that botulinum toxin, commonly known as Botox, can greatly improve symptoms of an overactive bladder (OAB). In a large study, onabotulinumtoxinA, a specific type of botulinum toxin, reduced the urgent need to urinate and the number of accidents. Patients reported an improved quality of life after treatment. However, some experienced side effects, such as urinary tract infections or the need for a catheter to assist with urination. Overall, botulinum toxin is considered effective for managing OAB symptoms when other treatments have failed. In this trial, participants will receive a combination of botulinum toxin and cineMRI-UDS to evaluate its effectiveness in treating OAB. ^{1 6 7 8 9}

Who Is on the Research Team?

Jennifer Anger, MD, MPH

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

I frequently feel a strong urge to urinate.

Exclusion Criteria

I am under 21 years old.

I am unable to understand and agree to the study's details.

You are afraid of being in small or enclosed spaces.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical botulinum toxin injections and undergo cineMRI-UDS to evaluate bladder physiology

10 months

Multiple visits for injections and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Botulinum toxin
• CineMRI-UDS

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Botulinum toxin and cineMRI-UDS

Botulinum toxin is already approved in United States, European Union, Canada 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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

OnabotulinumtoxinA (BOTOX) significantly reduces symptoms of overactive bladder, such as urgency and urinary incontinence, compared to placebo, based on a review of eight randomized controlled trials involving 1875 patients.

While effective in alleviating symptoms, onabotulinumtoxinA treatment is associated with a higher incidence of serious side effects, including urinary tract infections and urinary retention, indicating a need for careful consideration of risks versus benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficiency of onabotulinumtoxinA for the treatment of overactive bladder: a systematic review and meta-analysis. Sun, Y., Luo, D., Tang, C., et al.[2022]

Intravesical injection of botulinum toxin A has shown promising results in reducing symptoms of overactive bladder, outperforming placebo in terms of incontinence episodes and quality of life, based on eight studies.

While lower doses (100U to 150U) of botulinum toxin were beneficial, higher doses (300U) may provide even greater effectiveness; however, more robust data on safety and optimal dosing are still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin injections for adults with overactive bladder syndrome. Duthie, J., Wilson, DI., Herbison, GP., et al.[2018]

In a pilot study involving 28 patients with refractory overactive bladder (OAB) after surgery for benign prostatic hyperplasia (BPH), onabotulinumtoxinA (BOTOX) showed significant improvements in quality of life and lower urinary incontinence scores at 6 and 9 months post-treatment.

Patients receiving onabotulinumtoxinA experienced a reduction in urinary frequency from 11 to 8 voids per day, while the placebo group showed no change, indicating potential efficacy in managing OAB symptoms, although larger studies are needed for confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chughtai, B., Dunphy, C., Lee, R., et al.[2018]

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]

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]

In a study of 290 patients receiving intravesical onabotulinumtoxinA (BoNT-A) for overactive bladder, common adverse events included acute urinary retention (8.3%) and urinary tract infections (15.2%) within 3 months post-treatment.

Predictive factors for these adverse events included being male, older than 61 years, having a low maximum flow rate (Qmax), high post-void residual (PVR) volume, and low voiding efficiency, indicating that certain patient characteristics can help identify those at higher risk for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jiang, YH., Ong, HL., Kuo, HC.[2018]

In a study involving 97 patients across six urogynecology centers, OnabotulinumtoxinA (Botox) was primarily used as a second-line treatment for idiopathic overactive bladder after previous therapies like tibial or sacral neuromodulation failed, with 70% of first injections adhering to marketing authorization guidelines.

The study highlighted significant variability in diagnostic and treatment practices among centers, indicating a need for greater standardization in the use of Botox for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. Schneider, A., Tourlonias, B., Cormier, L., et al.[2019]

Botulinum toxin (BoNT) is primarily used as a third-line treatment for overactive bladder (OAB) among urogynecologists, but high-volume surgeons are more likely to use it as a first or second-line treatment, indicating a potential difference in treatment approaches based on experience.

The survey revealed significant variations in perioperative practices, such as the use of antibiotics, injection sites, and post-treatment monitoring, highlighting the need for standardized treatment protocols for BoNT in OAB management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Techniques for the Use of Botulinum Toxin in Overactive Bladder: Results of a Multinational Online Survey of Urogynecologists in Germany, Austria, and Switzerland. Lange, S., Koch, M., Lange, R., et al.[2023]

In a systematic review of 11 randomized controlled trials involving 1008 patients, onabotulinumtoxinA (BOTOX) was found to be significantly more effective than placebo in improving bladder control, symptoms, and quality of life for patients with refractory idiopathic overactive bladder (iOAB).

The treatment was well tolerated, with manageable adverse events such as urinary retention and infections, which did not negatively impact the patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Idiopathic overactive bladder and BOTOX(®): Literature review]. Gamé, X., Karsenty, G., Ruffion, A., et al.[2018]

A systematic review of 17 studies identified several factors that may predict poor response or adverse events (AEs) to botulinum toxin A (BTX-A) injections for overactive bladder, including male gender, frailty, comorbidities, and specific urodynamic parameters.

The review highlighted that while certain patient characteristics can help anticipate complications like the need for clean intermittent self-catheterization (CISC) and urinary tract infections (UTIs), the overall quality of the studies was low, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Poor Response and Adverse Events Following Botulinum Toxin A for Refractory Idiopathic Overactive Bladder: A Systematic Review. Abrar, M., Pindoria, N., Malde, S., et al.[2022]

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results of a phase 3, randomized, placebo controlled trial

OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2772973723009244

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

After 1st Botox treatment, 21% of patients developed urinary tract infections. Clean intermittent self-catheterisation (CISC) was performed in 33% of patients, ...

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botoxone.com

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Overactive Bladder - Efficacy

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pmc.ncbi.nlm.nih.gov/articles/PMC5167072/

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The combined safety data from the two pivotal RCTs reported a rate of 25.5% with onabotulinumtoxinA and 9.6% with placebo. The definition of UTI was a positive ...

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The most frequently reported adverse reactions for overactive bladder occurring within 12 weeks of injection include UTI (BOTOX 18%, placebo 6%); dysuria (BOTOX ...

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clinicaltrials.gov/study/NCT00311376

Safety and Efficacy Study of Botulinum Toxin Type A for the ...

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple ...

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Compared with the placebo, BoNT-A intradetrusor injections were associated with a significantly elevated risk of UTI (Risk Difference (RD) = 0.111, 95% CI = ...