Reduced-dose onabotuLinumtoxinA for urgency incontinence among older females (RELIEF): a randomized controlled trial with embedded qualitative and costing analyses.
Principal Investigator
Study Number
STUDY02001338
Summary
Urgency urinary incontinence (UUI) is a common problem of leaking urine, while having an urgent need to urinate. It is common among older women, and causes shame, discomfort and expense. The usual treatments for urgency incontinence are not very good for older patients. For example, some treatments have higher risks or are less successful for older patients. BOTOX medication is an effective and safe treatment that more than 4 out of 5 women like. (The formal name for this medication is onabotulinumtoxinA, also known as BOTOX©; we will refer to it as BTX here.) BTX is given by via small injections 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 urgency incontinence, it is less often used among older women, due to factors that are not well understood. We think that BTX is a good treatment for older women, but need to learn more. We also think that older women may benefit from use of a lower dose of the BTX medication. The goal of this research is to study the effectiveness and side effects of two doses of BTX treatment among older women. Some women will receive the standard dosage and others a lower dosage. We think the lower dosage is effective, and may have lower side effects. Rare side effects include urinary infection and difficulty emptying the bladder. We will also study reasons that one woman may benefit more from BTX treatment than another. As many as 40-60% of older women may have urgency incontinence. The results of this study may benefit many women.
Phase
N/A
Contact
Available at the following location(s)
- Lebanon
View more details at ClinicalTrials.gov
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