Fewer Botox Injections for Urinary Incontinence

Overseen By Monique Vaughan, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Anticholinergics

Disqualifiers: Neurologic disease, Pregnancy, Bladder malignancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether fewer Botox injections can effectively treat urgency urinary incontinence (UUI), a condition characterized by a sudden need to urinate. Instead of the usual 15-20 injections, the study examines the effectiveness of just 5 injections in reducing UUI episodes. Women who experience frequent UUI episodes and have tried other treatments without sufficient relief might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for UUI.

Will I have to stop taking my current medications?

If you were on anticholinergic therapy (medications that help reduce bladder spasms) before joining the trial, you need to have a 3-week period without taking them before enrolling. For other medications, the trial protocol does not specify if you need to stop taking them.

What prior data suggests that this reduced injection site protocol is safe for urinary incontinence?

Research has shown that Botox is usually well-tolerated for treating urinary incontinence. One study found that patients using Botox experienced fewer daily episodes of urinary incontinence. Most participants found it safe, with manageable side effects. Another study noted that while some individuals experienced repeated urinary tract infections (UTIs), Botox remained a safe long-term treatment for an overactive bladder. Overall, Botox has proven effective and safe for both men and women with bladder control issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new protocol for using Botox to treat urinary incontinence. Unlike the standard practice that involves injecting Botox into 15 different sites, this trial is testing whether the same amount of Botox can be effective when administered to just 5 sites. This streamlined approach could potentially reduce the discomfort and time associated with the procedure, making it a more appealing option for patients. By minimizing the number of injections while maintaining effectiveness, the trial could lead to a significant improvement in patient experience.

What evidence suggests that this trial's Botox injection protocols could be effective for urinary incontinence?

Studies have shown that Botox can treat urinary incontinence by reducing unwanted bladder contractions. In this trial, participants in the experimental arm will receive Botox at five injection sites. Research suggests that using fewer injection sites can be as effective as using more. One study found that five injection sites reduced urinary incontinence symptoms without losing effectiveness compared to the traditional method. Additionally, fewer injections might mean less discomfort during the procedure. This suggests that the new approach could offer the same benefits with potentially fewer side effects. ^{3 6 7 8 9}

Who Is on the Research Team?

Monique Vaughan, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 21 with urgency urinary incontinence, who have not had Botox injections for this condition before. They must be willing to possibly use a catheter and follow the study's procedures. Excluded are those with certain medical conditions, previous pelvic surgeries, or untreated UTIs.

Inclusion Criteria

I am a woman aged 21 or older.

Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this would be required

I am willing and able to follow the study's schedule and procedures.

Exclusion Criteria

You are allergic to botulinum toxin A.

I am recommended or planning to have surgery for stress incontinence or pelvic organ prolapse.

You have blood in your urine and have not been checked by a doctor.

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 intra-detrusor Botox injections, either 5 or 15 sites, and are monitored post-procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, completing questionnaires at 2 weeks, 3 months, and 6 months post-procedure

6 months

3 visits (phone interviews)

What Are the Treatments Tested in This Trial?

Interventions

• Botox

Trial Overview The study aims to see if fewer Botox injection sites (5 instead of the standard 15-20) will be just as effective in reducing episodes of urgency urinary incontinence. Participants will receive an equal amount of Botox but at different numbers of injection sites.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Subjects in this arm will be administered the same amount of Botox in 5 injection sites.

Group II: Controls Active Control 1 Intervention

Subjects in this arm will be administered the standard injection site protocol (15 sites).

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

In a study of 284 patients receiving intravesical Botox® for detrusor overactivity, those who took a 3-day course of oral fluoroquinolone antibiotics had a significantly lower rate of urinary tract infections (UTIs) at 20.8% compared to 36% in those who received a single intramuscular dose of ceftriaxone.

The findings suggest that a longer course of antibiotics, especially for patients with a positive preprocedure urine culture, may further reduce the risk of postprocedure UTIs following Botox® injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the ideal antibiotic prophylaxis for intravesically administered Botox injection? A comparison of two different regimens. Houman, J., Moradzadeh, A., Patel, DN., et al.[2020]

Onabotulinum toxin A is effective for treating urinary incontinence due to neurogenic detrusor overactivity and idiopathic detrusor overactivity, with significant improvements in urinary symptoms, quality of life, and bladder capacity after injections of 200 U and 100 U, respectively.

Adverse events from treatment are generally mild, primarily involving urinary tract infections and urinary retention in a small percentage of patients, and the effects of the treatment are temporary, requiring repeated injections for sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin treatment for bladder dysfunction. Santos-Silva, A., da Silva, CM., Cruz, F.[2013]

In a phase III trial involving 248 Japanese patients with overactive bladder, onabotulinumtoxinA significantly reduced daily urinary incontinence episodes by an average of 2.16 compared to placebo, indicating its efficacy in managing this condition.

While onabotulinumtoxinA improved symptoms and patient-reported outcomes, it was associated with a higher incidence of mild to moderate adverse events, such as urinary tract infections and urinary retention, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single-dose treatment from a phase III, randomized, double-blind, placebo-controlled trial (interim analysis). Yokoyama, O., Honda, M., Yamanishi, T., et al.[2022]

Repeat botulinum toxin A (BTX-A) injections can provide sustained improvements in quality of life for patients with neurogenic detrusor overactivity (NDO), particularly for those receiving four or fewer injections, based on a review of 18 studies involving 1533 patients.

The study found a low rate of adverse events associated with repeat BTX-A injections, indicating that the treatment is generally safe; however, quality of life may decline for patients receiving five or more injections, highlighting the need for further research on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is repeat Botulinum Toxin A injection valuable for neurogenic detrusor overactivity-A systematic review and meta-analysis. Ni, J., Wang, X., Cao, N., et al.[2019]

In a study of 281 women undergoing onabotulinumtoxinA injections for urgency incontinence, using multiple doses of prophylactic antibiotics did not significantly reduce the rate of urinary tract infections compared to a single dose, with infection rates of 13.8% and 10.3% respectively.

The study found that having a positive urine culture within 30 days post-injection greatly increased the odds of developing a urinary tract infection, highlighting the importance of monitoring urine cultures in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary tract infection following intradetrusor onabotulinumtoxina injection for non-neurogenic urgency incontinence: single- vs. multi-dose prophylactic antibiotic treatment regimens. Crouss, T., Kim, Y., Lai, E., et al.[2023]

Botulinum toxin injections, specifically OnabotulinumtoxinA, are recognized as a safe and effective treatment for refractory urinary incontinence, particularly in patients who do not respond to or cannot tolerate anticholinergic medications.

There are two approved uses for OnabotulinumtoxinA: 200 U for urinary incontinence due to neurological conditions and 100 U for overactive bladder symptoms, highlighting its versatility in treating different types of urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Botulinum Toxin in the Genitourinary System. Chancellor, MB., Smith, CP.[2021]

Botulinum toxin A (onabotulinumtoxinA) is effective in treating urinary incontinence caused by neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), significantly reducing urinary incontinence and improving quality of life in patients, particularly those with multiple sclerosis and spinal cord injuries.

While the treatment is generally safe, common adverse effects include urinary tract infections and the need for clean intermittent catheterization, especially in NDO patients. Long-term studies confirm the efficacy and safety of onabotulinumtoxinA for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of botulinum toxin for genitourinary conditions: What is the evidence? da Silva, CM., Chancellor, MB., Smith, CP., et al.[2018]

OnabotulinumtoxinA injections are a safe and effective second-line treatment for adults with refractory overactive bladder, showing improvement in 60%-65% of patients compared to placebo.

The optimal dose of 100 U, approved by the FDA, provides symptom relief for 6 to 12 months, with a low risk of urinary retention at around 6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA for the treatment of overactive bladder. Cox, L., Cameron, AP.[2023]

Botulinum neurotoxin (BoNT) injections into the bladder wall are an effective alternative for treating neurogenic detrusor overactivity (NDO) and urinary incontinence in patients who cannot tolerate anticholinergic medications, with FDA approval received in 2011.

The treatment has been shown to significantly decrease urinary incontinence and improve quality of life, while also increasing bladder capacity and reducing detrusor pressures, although common side effects include urinary tract infections and urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of botulinum toxin in individuals with neurogenic detrusor overactivity: state of the art review. Linsenmeyer, TA.[2022]

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 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 double-blind, placebo-controlled study involving 275 patients with urinary incontinence due to neurogenic detrusor overactivity, onabotulinumtoxinA significantly improved health-related quality of life (HRQoL) as measured by the Incontinence Quality of Life Questionnaire, with meaningful score increases compared to placebo.

Patients receiving onabotulinumtoxinA reported higher treatment satisfaction and a greater achievement of treatment goals at 6 and 12 weeks, indicating its efficacy in managing urinary incontinence compared to placebo, with no significant differences between the two doses tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Sussman, D., Patel, V., Del Popolo, G., et al.[2018]

In a study of 17 patients with neurogenic detrusor overactivity, repeated botulinum toxin type A injections were found to be safe, with no systemic side effects reported across 91 injections.

The treatment effectively reduced incontinence episodes to zero and significantly improved bladder capacity and pressure, maintaining these benefits consistently after multiple injections without affecting bladder compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistence of therapeutic effect after repeated injections of botulinum toxin type A to treat incontinence due to neurogenic detrusor overactivity. Karsenty, G., Reitz, A., Lindemann, G., et al.[2010]

OnabotulinumtoxinA (BoNT-A) injections significantly improved lower urinary tract symptoms (LUTS) in 30 men with primary bladder-neck dysfunction, with total symptom scores decreasing from 21.9 at baseline to 7.8 at 2 months, indicating effective symptom relief.

The treatment was found to be safe, with no significant adverse effects or ejaculatory dysfunction reported, although the benefits appeared to diminish over time, suggesting the need for repeated injections for sustained improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder-neck dysfunction: objective and patient-reported outcomes. Sacco, E., Tienforti, D., Bientinesi, R., et al.[2018]

Citations

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Reduced versus standard intradetrusor ... The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard ...

2. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004660

The Efficacy and Safety Between Intradetrusor ... The aim of the study is to investigate whether intradetrusor onabotulinumtoxinA injection demonstrates superior efficacy and fewer side effects ...

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Overactive Bladder Study Finds Fewer Botox Injections ... Houston Methodist study on overactive bladder Botox treatment finds fewer injection sites can reduce pain while maintaining the same ...

4. mdpi.com mdpi.com/2072-6651/17/5/211

Intravesical Onabotulinum Toxin A Injection Paradigms for ... 29.8%), but demonstrated both reduced and less sustained efficacy outcomes compared to the 100 U or higher doses (37–57%). However, the 50 U dose exhibited the ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25290

Efficacy and safety of an alternative onabotulinumtoxinA ... An alternative injection paradigm of fewer injections targeting the lower bladder may reduce the need for CIC by maintaining upper bladder ...

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

Evaluating the Efficacy and Safety of Botulinum Toxin in ... The primary outcomes were improvements in daily urinary incontinence (UI) episodes and patient-reported outcomes, while the secondary outcomes ...

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

16 year's experience of a Tertiary Centre in the UK Recurrent UTIs developed in 23%. Conclusion: Repeated Botox injections appear to be a safe form of treatment for refractory OAB. Long term complications include ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01600716

Safety and Efficacy Study of OnabotulinumtoxinA for the ... This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing ...

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Efficacy and safety of onabotulinumtoxinA for the treatment ... OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH.