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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two brands of a muscle-relaxing drug for treating overactive bladder in women aged 18 and older. The treatment works by relaxing the bladder muscle to help control the urge to urinate.

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.

What data supports the effectiveness of the drug for treating overactive bladder?

Research shows that Botox (onabotulinumtoxinA) injections are effective in treating symptoms of overactive bladder, such as urgency and incontinence, in various patient groups. Studies have documented improvements in symptoms and patient satisfaction, indicating its potential as a treatment option. ^{1 2 3 4 5}

Is onabotulinumtoxinA (Botox) safe for treating overactive bladder?

OnabotulinumtoxinA (Botox) has been shown to be generally safe for treating overactive bladder, but some patients may experience adverse events (unwanted side effects) such as difficulty urinating. Studies have assessed its safety in various conditions, confirming its use in humans. ^{6 7 8 9 10}

How does the drug Xeomin differ from other treatments for overactive bladder?

Xeomin, like Botox, is a form of botulinum toxin type A used for overactive bladder, but it is unique because it can be effective for patients who do not respond to standard drug therapies. It works by reducing involuntary bladder muscle contractions, improving symptoms and quality of life without significant complications. ^{1 2 11 12 13}

Research Team

Anna S Trikhacheva, MD

Principal Investigator

Walter Reed Army Institute of Research (WRAIR)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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 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 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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Intravesical OnabotulinumtoxinA Injection for Overactive Orthotopic Ileal Neobladder: Feasibility and Efficacy. [2020]

2. Canada 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of botulinum toxin injection in the treatment of de novo OAB symptoms following midurethral sling surgery. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Urinary retention in female OAB after intravesical Botox injection: who is really at risk? [2018]

5. United States 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. [2022]

6. Korea (South) 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. [2020]

7. Australia pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The safety and efficiency of onabotulinumtoxinA for the treatment of overactive bladder: a systematic review and meta-analysis. [2022]

10. United States 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. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Correction of overactive bladder with botulinum toxin type A (BTX-A). [2021]

12. England 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? [2018]

13. France pubmed.ncbi.nlm.nih.gov

[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. [2019]