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Has your doctor diagnosed you with overactive bladder (OAB)?
You may qualify for the BETTER: Control OAB Clinical Trial
This clinical trial is evaluating the safety and effectiveness of a new investigational treatment versus Botox® (intradetrusor onabotulinumtoxinA) for the treatment of OAB.
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Is this trial right for me?
You may be a candidate for the BETTER: Control OAB Clinical Trial if you can answer YES to the following questions:
I have been suffering from OAB for at least 6 months
I have tried 2 medications for OAB, but they were not successful
I have never tried Botox before OR I have tried Botox and had favorable results
I am not pregnant or breastfeeding
I am at least 18 years of age
The trial doctor or one of their care team members will talk to you about other important information that will help you decide if this trial is right for you.
Trial FAQs
The trial is designed to study the safety and effectiveness of a new investigational device that treats OAB.
Patients who participate in the trial will be randomly selected to receive the new investigational treatment or Botox, and the results will be compared.
If you choose to participate in the trial, you will receive one of two treatments:
New investigational treatment: a minimally invasive treatment that uses a small device that goes into your bladder and uses energy that is intended to stop the nerves in your bladder from sending false urgency signals to your brain. When the procedure is finished, the device is completely removed from your bladder without any cuts or stitches.
Existing treatment: a minimally invasive treatment that uses a small device that goes into your bladder to inject Botox into your bladder muscles to help prevent your bladder muscles from involuntary contractions and squeezing. When the procedure is finished, the device is completely removed from your bladder without any cuts or stitches.
You will not know which treatment you receive, as it could affect the outcomes of the trial.
Yes. A feasibility study has been completed. The purpose of the BETTER pivotal clinical trial is to determine whether this new investigational treatment is safe and effective.
If you choose to join the trial, you will:
- Receive treatment
- Complete bladder diaries that track your progress
- Attend follow-up visits with your trial doctor
– First visit at 2 weeks after treatment
– Then at 1, 3, 6, 9, and 12 months
You will also have access to a portal on this website where you can view announcements, receive reminders, and use other resources that support you throughout the trial.
When you join the trial, you will be given tools to support your treatment journey during the trial.
In most cases, you will contact the trial site coordinator if you have a question. If you have a medical question or need, the trial site coordinator will put you in touch with the trial doctor.
Remember you will have scheduled follow-up visits with the trial doctor, which will provide a good opportunity to share your questions and talk to the doctor one-on-one.
You will receive compensation as you successfully attend scheduled visits with your trial doctor throughout your enrollment in the trial.
The doctor will provide detailed information about the amount of compensation you are eligible to receive before you decide to enroll in the trial.
Interested in joining the trial?
Review the list of participating trial sites below to find the location closest to you.
Reference: 1. Hologic, Inc. Data on file; OAB Assessment Quantitative Report, conducted July 2021. Survey of 316 women (203 who suffered from OAB; 113 who suffered from mixed incontinence). ro.2018.09.043.
