Botox Injections for Overactive Bladder

Overseen By Zachary Selzler, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Must be taking: Botulinum toxin

Disqualifiers: Pelvic pain, Interstitial cystitis, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Botox injections for individuals with overactive bladder (OAB) when they choose follow-up times based on their symptoms. It aims to determine if adjusting the time between treatments, rather than adhering to the usual 6-month schedule, improves patient satisfaction and well-being. Participants will receive standard Botox injections into the bladder and then decide whether to have their next treatment at the usual interval or when symptoms return. This trial suits individuals diagnosed with OAB-related conditions, such as urinary frequency or urgency, who seek Botox treatment. As an unphased trial, it offers flexibility and personalization, allowing participants to tailor their treatment schedule to their needs.

Will I have to stop taking my current medications?

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 botulinum toxin injections are safe for treating overactive bladder?

Studies have shown that botulinum toxin (commonly known as Botox) injections for treating overactive bladder are generally safe and well-tolerated. Research indicates that doctors can safely administer these injections in an office setting, and most patients manage them well. The most common side effect is a urinary tract infection (UTI), which can occur within 12 weeks after the injection. Other side effects are possible but occur less frequently.

These conclusions are based on multiple studies that examined different types of botulinum toxin injections. The FDA has already approved this treatment for overactive bladder, providing extensive safety information. Discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Botox injections for overactive bladder because they offer a new way to manage symptoms. Unlike typical treatments like anticholinergic medications or beta-3 adrenergic agonists, Botox works by relaxing the bladder muscle, providing relief from frequent urination and urgency. This treatment is unique because it allows for a more flexible follow-up schedule, where patients can decide when they need another injection based on their symptoms, offering a personalized approach to care.

What evidence suggests that this treatment might be an effective treatment for overactive bladder?

Studies have shown that botulinum toxin injections effectively treat overactive bladder (OAB). Research indicates that patients with OAB who did not respond to medication reported significant improvements after receiving these injections. Specifically, between 87.2% and 100% of patients with OAB of unknown cause found the injections effective. Additionally, 74.5% of women who received these injections stopped using pads altogether, demonstrating significant symptom relief. Overall, botulinum toxin injections have a strong track record of reducing bladder symptoms in patients. In this trial, participants will follow either a standard follow-up schedule or a patient-directed follow-up schedule to assess the effectiveness of botulinum toxin injections for OAB. ^{2 6 7 8 9}

Who Is on the Research Team?

Lisa Peacock, MD

Principal Investigator

Louisiana State University Health Science Center - New Orleans

Are You a Good Fit for This Trial?

This trial is for individuals with overactive bladder and related urinary issues who have previously responded to botulinum toxin injections. Participants will decide when they need follow-up treatments rather than following a standard schedule.

Inclusion Criteria

I have been diagnosed with an overactive bladder or related symptoms.

I am considering or planning to receive Botox injections in my bladder.

Exclusion Criteria

I have been diagnosed with conditions like pelvic pain or interstitial cystitis, not OAB.

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 (BTX-A) injection for overactive bladder treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for symptom control and patient satisfaction post-injection

1-2 weeks

1 visit (in-person)

Patient-directed follow-up

Participants decide their own follow-up interval for repeat injection based on symptomatology

3-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Intra-Detrusor Botulinum Toxin

Trial Overview The study tests if patient-directed follow-up times for botulinum toxin injections into the bladder are more effective than the usual 6-month interval in managing symptoms of overactive bladder.

How Is the Trial Designed?

Group I: Patient-directed follow up Experimental Treatment 1 Intervention

Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months)

Group II: Standard of care Active Control 1 Intervention

Standard 6 month post-operative follow up interval for repeat injection

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Published Research Related to This Trial

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3649594/

The use of botulinum toxin for the treatment of overactive ... A recent growing body of evidence suggests that intra-detrusor injection of botulinum toxin may have beneficial effects in patients with medication refractory ...

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

The Efficacy and Safety Between Intradetrusor ... Conclusions: Both intradetrusor onabotulinumtoxinA and combined pharmacotherapy improved symptoms in women with refractory overactive bladder.

3. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.479

Long‐term follow‐up of intradetrusor botulinum toxin ... Self-reported efficacy post-BoNT injection ranged from 85.7 to 100% for patients with MS and 87.2 to 100% for patients with idiopathic OAB. MS ...

4. mdpi.com mdpi.com/2072-6651/16/8/332

Insights from 15 Years of Botulinum Toxin Use for Female ... Among 368 women receiving botulinum toxin injections, 74.5% achieved a complete discontinuation of pad usage. Predictors of efficacy included ...

5. ics.org ics.org/2021/abstract/376

intradetrusor botulinum toxin type a for treatment of oab ... The primary efficacy outcome was defined as improvement of >50% according to patient self-assessment 2 weeks after treatment. A second endpoint was the interval ...

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

Evaluating Botulinum Toxin for Overactive Bladder in Elderly 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.

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

Efficacy & Safety: BotulinumtoxinA for Overactive Bladder A non-inferiority clinical study evaluated the efficacy and safety of abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections in women with ...

8. ics.org ics.org/2020/abstract/385

Intradetrusor injections of Botulinum toxin A for detrusor ... This study shows that the intradetrusor injections of BTX-A can be safely administered in an office-based setting and are well tolerated by patients. In terms ...

9. botoxone.com botoxone.com/oab/dosing

Overactive Bladder - Dosing and Administration The most frequently reported adverse reactions within 12 weeks of BOTOX injection for detrusor overactivity associated with a neurologic condition include UTI ( ...