BOTOX Injections for Bladder Pain Syndrome
(IC/BPS POC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of BOTOX injections for women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), a condition causing bladder pain and discomfort. Participants will receive either BOTOX (OnabotulinumtoxinA) or a placebo (a substance with no active drug) to determine if BOTOX can reduce symptoms. Women who have experienced IC/BPS symptoms for at least six months and have confirmed bladder pain might be suitable for this study. Participants must visit a hospital or clinic regularly for assessments, including medical check-ups and questionnaires, over a 12-week period. 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 medical advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctors to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BOTOX injections are generally safe and effective for treating bladder pain syndrome. Patients with bladder issues have experienced significant relief with BOTOX treatments. Importantly, these treatments have shown no major safety concerns. For example, one study found BOTOX effective and safe for reducing symptoms without serious side effects. Another study noted that repeated BOTOX injections were safe and well-tolerated over time. Overall, the evidence suggests that BOTOX can be a safe option for managing bladder pain and discomfort.12345
Why do researchers think this study treatment might be promising?
Most treatments for bladder pain syndrome, like oral medications and physical therapy, focus on symptom relief. But BOTOX offers a different approach by directly targeting the bladder muscles with injections to potentially reduce pain and improve bladder function. Researchers are excited about BOTOX because it has the potential to provide longer-lasting relief with fewer systemic side effects compared to traditional systemic medications. Additionally, BOTOX's targeted method may offer a new option for patients who haven't found success with other treatments.
What evidence suggests that BOTOX might be an effective treatment for bladder pain syndrome?
Research shows that BOTOX injections, which participants in this trial may receive, can reduce bladder pain and discomfort in people with Bladder Pain Syndrome (BPS) and Interstitial Cystitis (IC). Studies have found that these injections lessen pelvic pain and improve bladder-related symptoms. A review of several studies confirmed that BOTOX injections are both safe and effective for these conditions. Another study reported less bladder pain after BOTOX treatment. Although BOTOX can slightly increase the amount of urine left in the bladder after urination, the overall benefits for reducing pain are promising. Participants in this trial may also receive a placebo to help determine BOTOX's effectiveness compared to no active treatment.23567
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for adult women aged 18-75 with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who've had symptoms for at least 6 months. It's not open to those with a history or current diagnosis of Hunner Lesions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive BOTOX or placebo injected into the bladder and are followed for at least 12 weeks
Treatment Period 2 (Optional)
Eligible participants may request an additional dose of BOTOX between Weeks 12 and 24, followed by 12 weeks of follow-up
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BOTOX
- Placebo for BOTOX
Trial Overview
The study tests the safety and effectiveness of BOTOX injections versus placebo in treating IC/BPS. Participants are randomly assigned to receive either BOTOX or a placebo, with a follow-up period of up to 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive BOTOX on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.
Participants will receive placebo on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.
BOTOX is already approved in European Union, United States, Canada for the following indications:
- Chronic migraine
- Involuntary muscle contractions or twitching
- Excessive sweating
- Increased saliva
- Overactive bladder
- Crow's Feet
- Glabellar Lines
- Facial Wrinkles
- Orbicularis Oculi
- Platysma Bands
- Chronic migraine
- Involuntary muscle contractions or twitching
- Excessive sweating
- Increased saliva
- Overactive bladder
- Crow's Feet
- Glabellar Lines
- Facial Wrinkles
- Orbicularis Oculi
- Platysma Bands
- Cervical Dystonia
- Blepharospasm
- Chronic Spasticity
- Bruxism
- Dystonia
- Headache
- Similar to those in the United States and European Union, specific details may vary
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Allergan
Lead Sponsor
Brent Saunders
Allergan
Chief Executive Officer since 2015
JD and MBA from Temple University
Dr. David Nicholson
Allergan
Chief Medical Officer since 2015
MD from Harvard Medical School
Citations
Intravesical Botulinum Toxin A Injections for Bladder Pain ...
This meta-analysis indicates that intravesical BTX-A injections may be an effective and safe treatment for patients with BPS/IC. BTX-A injections may be ...
Botulinum Toxin Therapy for Bladder Pain Syndrome ...
The results revealed that despite a slight increase in PVR levels, Botox® injections reduced pelvic pain, ICPI, and ICSI. Except for a ...
Comparison of the Clinical Efficacy and Adverse Events ...
Patients were also informed that the BoNT-A injection could lead to a greater reduction in bladder pain, and both BoNT-A and PRP injection could ...
Study of BOTOX Injections to Assess Change in Disease ...
This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated.
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 ...
Bladder instillations vs onabotulinumtoxinA injection for ...
Both onabotulinumtoxinA injection and bladder instillations are safe, effective treatments for patients with IC/BPS, with significant clinical improvement ...
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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