Onabotulinum Toxin A for Interstitial Cystitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different treatments for bladder pain syndrome (also known as interstitial cystitis) affect women's sexual function. It compares the effects of bladder Botox injections to conservative management techniques, such as diet and lifestyle changes. The trial seeks women diagnosed with bladder pain syndrome who have a high discomfort score on a specific questionnaire. Participants will help determine which treatment better improves sexual health and other symptoms related to their condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings in women's health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently using an alternative treatment for bladder pain syndrome, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that injecting Botox directly into the bladder is generally safe for treating bladder issues like interstitial cystitis/bladder pain syndrome (IC/BPS). Studies have found that this treatment effectively reduces bladder pain and other uncomfortable symptoms. Most patients tolerate it well, with many not experiencing serious side effects.
Common side effects can include urinary tract infections or the need for a catheter due to difficulty emptying the bladder, but these are usually manageable. Overall, Botox injections into the bladder are considered a safe option for those with challenging bladder problems.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using onabotulinumtoxinA, commonly known as bladder Botox, for treating bladder pain syndrome because it offers a unique approach compared to standard treatments like pain medications and physical therapy. Unlike these conventional options that generally aim to manage symptoms, bladder Botox works by directly reducing muscle spasms and pain in the bladder through targeted injections. This method can provide more immediate and potentially longer-lasting relief. Additionally, bladder Botox might improve sexual function, a significant concern for many patients with bladder pain syndrome, offering a dual benefit that standard treatments typically don't address.
What evidence suggests that this trial's treatments could be effective for IC/BPS?
Studies have shown that injecting onabotulinumtoxinA, commonly known as bladder Botox, directly into the bladder can effectively treat interstitial cystitis (IC) or bladder pain syndrome (BPS). Research indicates that these injections significantly reduce bladder pain and improve symptoms for patients who haven't found relief from other treatments. In this trial, one group of participants with bladder pain syndrome will receive bladder Botox treatment. Specifically, one study found that bladder Botox worked better than other methods, like bladder instillations, in reducing symptoms two months after treatment. Additionally, bladder Botox has been shown to help decrease the frequency of urination during the day. These findings suggest that bladder Botox could be a promising option for improving the quality of life in women with IC/BPS.23567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intradetrusor onabotulinumtoxinA injection or conservative management for bladder pain syndrome
Follow-up
Participants are monitored for changes in sexual function and adverse events post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Onabotulinum toxin A
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
49 healthy control patients complete the questionnaire packet once. No additional follow-up is completed.
55 patients with bladder pain syndrome who choose treatment with conservative management complete pre-treatment and 12-week post-treatment questionnaires.
55 patients with bladder pain syndrome who choose treatment with bladder Botox complete pre-treatment and 12-week post-treatment questionnaires.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Walter Reed National Military Medical Center
Lead Sponsor
Citations
Intravesical Botulinum Toxin A Injections for Bladder Pain ...
Intravesical BTX-A injections might offer significant improvement in bladder pain symptoms, daytime urination frequency, and MCC for patients with refractory ...
Bladder instillations vs onabotulinumtoxinA injection for ...
Intradetrusor onabotulinumtoxinA injection is more effective than bladder instillations for treatment of IC/BPS at 2 months posttreatment. This ...
Safety and efficacy of intravesical instillation of botulinum ...
However, the results of the meta-analysis indicated that intravesical instillation of BTX-A could reduce episodes of urgency urinary incontinence (UUI) (overall ...
Clinical application of intravesical botulinum toxin type A ...
Recent results show that Botox is effective for relieving bladder pain and bothersome bladder symptoms in patients with refractory IC/BPS. Short ...
Bladder instillations vs onabotulinumtoxinA injection for ...
Both bladder instillation and onabotulinumtoxinA injection therapy are effective for treatment of interstitial cystitis (IC)/bladder pain syndrome (BPS), but a ...
Safety and efficacy of intravesical instillation of botulinum toxin ...
The meta-analysis was performed to assess the efficacy and safety of a novel intravesical instillation of BTX-A for managing overactive bladder ...
ICS 2018: Efficacy, Complications and Tolerability of ...
The authors concluded that repeated intravesical BOTOX injection is an effective, well tolerated and safe treatment modality for patients with IC/PBS. It has a ...
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