The RELIEF Study

The RELIEF* study is to help improve how we treat urinary urgency, frequency and associated leakage among older women. Urgency Urinary Incontinence (UUI), also called overactive bladder, is when you feel a sudden, strong desire to pass urine that results in leakage before reaching the toilet. Urgency-related leakage is common among older women, and causes shame, discomfort and expense.   

  • BOTOX©** medication is an effective and safe treatment that more than four out of five women find satisfactory. BTX is less used among older women, partly due to fewer research studies.  
  • We want to understand the effectiveness and side effects of one of two different doses of BTX.  
  • We also want to understand women’s experience of having urgency incontinence and goals of treatment.


*Reduced-dose onabotulinumtoxinA for urgency incontinence among older women

**onabotulinumtoxinA (BTX, trade name BOTOX©)


Why is this study important?

  • In this study we are trying to find out how well BTX treatment works specifically for older women. It is already a commonly used treatment among younger women. We expect that the usual dose will work well for older women too, but we also want to study use of a lower dose of the BTX medicine which we believe will also work well in older women with less side effects. 
  • This study will provide evidence of the effectiveness, safety and quality of life improvement of BTX treatment among older women.  


Who is eligible for this study?

  • If you are 70 years old or older.
  • If you usually experience urine leakage with a feeling of urgency, that is strong. 
  • If you have two or more episodes of urinary urgency incontinence per day, three days in a row.
  • If you are eligible based on your responses to questionnaires.  

What will I be asked to do?

  • Sign consent to participate in the study.
  • You will be asked to keep track of leakage episodes for three days.
  • You will be in the study for up to 15 months.
  • Complete questionnaires.
  • You will be assigned by chance (like the flip of a coin) to receive treatment with BTX with one of two different doses. You will have an equal chance of receiving either dose. BTX is given by small injections in the bladder during a well-tolerated office procedure.  
  • Come to the office about one week after the BTX treatment to make sure you are emptying your bladder normally. 
  • Complete monthly phone check-ins with brief questionnaires after the treatment. 


Can I drop out of the study once I have begun?


Yes. Participation in the study is voluntary and you can stop the study at any time. If you decide to stop the study, we will still take care of you in the same way.


What will the study cost me?


There are no additional costs to you for this study. Any medical care outside of the study will be charged to you or your insurance.

You will receive up to $300 in compensation for your time and effort if you participate in the study.

Additionally, up to $200 will be paid if you agree to participate in subsequent interviews.





What happens to the information collected about me?


All personal information will be kept private. You will not be able to see information from the study until the end of the study. However, it will be available to your doctors to use if needed for your care. While information collected from this study may be presented in a scientific journal, your identity will be protected.