RELIEF Study

STUDY BASICS

Do you experience urgent urinary incontinence? Are you a woman age 70 or older? You may be eligible for a research study to understand women's experience, treatment expectations, and quality of life impact of having urinary incontinence.

STUDY PURPOSE

Urgency urinary incontinence (UUI) is a common problem of leaking urine, while having an urgent need to urinate. It is common among older women (ages 70 and older), and causes shame, discomfort and expense.  

BOTOX medication is an effective and safe treatment that more than 85% of women like. (The formal name for this medication is onabotulinumtoxinA, also known as BOTOX; referred to here as BTX). BTX is given via small injection in the bladder during an office procedure. BTX treatment improves UUI for 4-11 months. Most women need the treatment to be repeated about 1-2 times per year. Although bladder BTX is effective and safe among all age women to treat urinary incontinence, it is less often used among older women, due to fewer research studies. The goal of this research is to study the effectiveness and side effects of two different doses of BTX treatment among older women. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants:

• Are women ages 70 and older 
• Have tried at least one medication for overactive bladder
• Have issues with leakage when standing, coughing, sneezing or doing exercise
• Usually experience urine leakage with a feeling of urgency
• Have 2 or more episodes of UUI per day for 3 days in a row 

WHAT PARTICIPANTS CAN EXPECT

You will receive treatment for your overactive bladder with onabotulinumtoxinA (BTX, trade name BOTOX), with either regular or lower dose of the BTX. You will come to the clinic one week after the BTX injection to check that you are emptying your bladder. After that, you will have monthly telephone or video visits for 12 months that will ask a range of questions about your symptoms, to see how well the BTX treatment is working. This will include a brief questionnaire about depression. 

For three days, you will keep a tally of when you urinate (empty your bladder) and when you leak urine. You will keep this tally at the beginning of the study and at 1, 3, and 6 months after BTX treatment. 

Will it cost me anything to participate?

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

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

Yes, Participation is completely voluntary and you can stop the study at any time.  Stopping the study will not result in any penalty from this health care facility at all.