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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are: * Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone? * Does symptom control or patient satisfaction change when patients control their own follow up times? Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.

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

Research shows that Botox injections into the bladder muscle can help improve symptoms for people with overactive bladder, including those who haven't responded to other treatments. It has been found effective in both neurogenic (nerve-related) and non-neurogenic cases, improving quality of life by reducing bladder overactivity. ^{1 2 3 4 5}

Is Botox safe for treating overactive bladder?

Botox injections for overactive bladder have been studied and are generally considered safe, but some people may experience side effects like difficulty urinating. These side effects are common in treatments for overactive bladder and are usually manageable. ^{6 7 8 9 10}

How is the drug Botox different from other treatments for overactive bladder?

Botox injections for overactive bladder work by relaxing the bladder muscle, which reduces the urge to urinate frequently. This treatment is unique because it involves injecting the drug directly into the bladder muscle, unlike oral medications that are taken by mouth. Botox is often used when other treatments have not been effective. ^{1 4 11 12 13}

Research Team

Lisa Peacock, MD

Principal Investigator

Louisiana State University Health Science Center - New Orleans

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

References

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

What a patient with refractory idiopathic detrusor overactivity should know about botulinum neurotoxin type a injection. [2010]

2. Germany pubmed.ncbi.nlm.nih.gov

Experience with injections of botulinum toxin type A into the detrusor muscle. [2010]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Patient follow-up after botulinum toxin intradetrusor injection. Proposal for management in neurogenic patients]. [2010]

4. France pubmed.ncbi.nlm.nih.gov

[Seniority of neurobladder and effectiveness of a first intradetrusor injection of botulinum toxin]. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Role of botulinum toxin-A in refractory idiopathic overactive bladder patients without detrusor overactivity. [2021]

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

Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. [2015]

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

Onabotulinum toxin A: a therapeutic option for refractory neurogenic detrusor overactivity and idiopathic overactive bladder. [2018]

9. 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]

10. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intradetrusor botulinum toxin injections for idiopathic overactive bladder syndrome in patients with an artificial urinary sphincter. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A injection for neurogenic detrusor overactivity: clinical outcome in Japanese patients. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. [2018]

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

Increased risk of large post-void residual urine and decreased long-term success rate after intravesical onabotulinumtoxinA injection for refractory idiopathic detrusor overactivity. [2018]