Xeomin vs Botox for Overactive Bladder

Overseen By Anna S Trikhacheva, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Anticholinergics, Beta 3 agonists

Disqualifiers: Pregnancy, Neurogenic bladder, Prolapse, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Xeomin and Botox, to evaluate their effectiveness for overactive bladder, a condition causing sudden urges to urinate and occasional leaks. Researchers aim to determine if Xeomin, similar to Botox, can be equally effective while potentially costing less. Women aged 18 and older who have tried other treatments, such as medications or lifestyle changes, without success and are willing to perform self-catheterization might be suitable candidates. Participants will receive either Xeomin or Botox (also known as OnabotulinumtoxinA) and will attend follow-up visits to monitor their progress.

As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any oral medications for overactive bladder, like anticholinergics or beta 3 agonists, to participate in this trial.

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

Research shows that Xeomin and Botox are both types of botulinum toxin A used to treat overactive bladder (OAB), which causes a sudden need to urinate. Studies have found that Xeomin and Botox have similar safety profiles, meaning they tend to cause similar side effects.

Common side effects reported by patients using these treatments include urinary tract infections (UTIs) and painful urination. Specifically, about 18% of patients using Botox experienced UTIs, compared to only 6% with a placebo. These side effects usually occur within 12 weeks after the injection.

Xeomin has undergone long-term study, with follow-ups lasting around 58 months. This research indicates that repeated injections can be safe over time. Both treatments are generally well-tolerated by many people, but some side effects can still occur.

Overall, both Xeomin and Botox have a strong safety record for treating overactive bladder. However, potential trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Xeomin as a treatment for overactive bladder because it offers a similar mechanism of action to Botox but with potential advantages. Both Xeomin and Botox are forms of botulinum toxin type A, which work by relaxing the bladder muscle to reduce symptoms. However, Xeomin is free from accessory proteins, which may reduce the risk of developing antibodies that can decrease effectiveness over time. This characteristic could mean longer-lasting relief for patients compared to current treatments.

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

In this trial, participants will receive either Botox (onabotulinumtoxinA) or Xeomin (incobotulinumtoxinA) to treat overactive bladder. Research has shown that Botox effectively reduces daily leakage and improves patients' quality of life, with noticeable symptom reduction as soon as two weeks after treatment. Similarly, Xeomin, another form of the same botulinum toxin type A, is believed to work just as well. Reviews of research have found that both Botox and Xeomin outperform placebo treatments in reducing urinary incontinence in older patients. Both treatments offer promising options for managing overactive bladder symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Anna S Trikhacheva, MD

Principal Investigator

Walter Reed Army Institute of Research (WRAIR)

Are You a Good Fit for This Trial?

This trial is for women over 18 with Overactive Bladder Syndrome who've tried at least one other treatment without success. They must be willing to self-catheterize, follow the study's instructions, and not be pregnant or planning pregnancy during the study. Participants should have no recent botox treatments for bladder issues, no severe prolapse untreated, and speak English.

Inclusion Criteria

I can follow the study's instructions and attend all follow-ups.

I have tried at least one treatment or behavior change for my condition without success, or I chose not to try them.

I am a woman aged 18 or older.

Exclusion Criteria

I have not had botulinum toxin injections in my bladder in the last 6 months.

I cannot use certain botulinum toxin treatments due to health reasons.

I have a severe untreated pelvic organ prolapse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either 100 units of onabotulinumtoxinA or incobotulinumtoxinA injected into the detrusor muscle

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of surveys and assessment of symptoms

2-6 weeks

1 visit (in-person or virtual)

Long-term Follow-up

Participants are contacted for final assessment of symptoms and adverse events

6-9 months

1 contact (phone or email)

What Are the Treatments Tested in This Trial?

Interventions

• Botox
• Xeomin

Trial Overview The trial compares two botulinum toxin A injections: Xeomin and Botox in treating Overactive Bladder Syndrome. It's a single-blinded study where participants are randomly assigned to receive either Xeomin or Botox but only the provider knows which one they get.

How Is the Trial Designed?

Group I: Xeomin Experimental Treatment 1 Intervention

100units xeomin dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each

Group II: Botox Active Control 1 Intervention

100units Botox dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each

Botox is already approved in United States, European Union 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

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Published Research Related to This Trial

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 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 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 of 686 Korean patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO) or overactive bladder (OAB), onabotulinumtoxinA significantly reduced UI symptoms, with 64.9% of NDO patients and 47.3% of OAB patients showing a meaningful improvement of over 5 points on the ICIQ-SF scale.

The treatment was found to be safe, with only a small percentage of patients experiencing adverse drug reactions (5.6% for NDO and 3.2% for OAB), primarily related to urinary tract issues, indicating a favorable risk-benefit profile for onabotulinumtoxinA in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Korean Postmarketing Study Assessing the Effectiveness of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity or Idiopathic Overactive Bladder Using a Validated Patient-Reported Outcome Measure. Ko, KJ., Jenkins, B., Patel, A., et al.[2020]

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]

In a study of 313 patients with idiopathic overactive bladder (OAB), onabotulinumtoxinA (BOTOX®) significantly reduced urinary urgency incontinence (UUI) episodes and improved urodynamic parameters, particularly at doses of 100 U or higher, compared to placebo.

The treatment was effective regardless of whether patients had detrusor overactivity (DO) at baseline, indicating that the success of onabotulinumtoxinA in managing OAB is not dependent on the presence of DO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxinA in a randomized, placebo-controlled dose-finding study in idiopathic overactive bladder. Rovner, E., Kennelly, M., Schulte-Baukloh, H., et al.[2022]

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]

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]

In a study of 207 patients with non-neurogenic overactive bladder, both onabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport) showed similar effectiveness in reducing symptoms like daytime frequency and incontinence episodes.

However, abobotulinumtoxinA was associated with a significantly higher rate of urinary retention requiring intermittent self-catheterization (42% vs 23%), indicating that these two treatments are not interchangeable at the doses used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox(®) ) or abobotulinumtoxinA (Dysport(®) ) make a difference? Ravindra, P., Jackson, BL., Parkinson, RJ.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10222470/

Retrospective Observational Study of Treatment Patterns ... The duration and effectiveness of onabotulinumtoxinA treatment were analyzed using the overactive bladder symptom score and voiding diaries. A ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772973723009244

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 ...

3. botoxone.com botoxone.com/oab/efficacy

Overactive Bladder - Efficacy As early as 2 weeks, significant reductions in daily leakage episodes were observed.1. Study 1 and 2 design: Double-blind, placebo-controlled, randomized, ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25538

Efficacy and safety of onabotulinumtoxinA for the treatment ... OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37746881/

Efficacy and safety of an alternative onabotulinumtoxinA ... Treatment benefit was improved or greatly improved in the onabotulinumtoxinA group (74.0% of patients) versus placebo (17.6%) (OR: 13.03 [95% CI ...

6. link.springer.com link.springer.com/article/10.1007/s00508-024-02412-7

Efficacy and safety of intradetrusor abobotulinumtoxinA ... A non-inferiority clinical study evaluated the efficacy and safety of abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections in women with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597992/

Evaluating the Efficacy and Safety of Botulinum Toxin in ... This study aimed to evaluate the efficacy and safety of BoNT-A intradetrusor injections in elderly OAB patients through a systematic review and meta-analysis.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06034288

Xeomin vs Botox for Treatment of Overactive Bladder ... IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA ...

9. botoxone.com botoxone.com/oab/safety

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