Description of problem: Urgency urinary incontinence (UUI) is a common condition in women and is associated with a poor quality of life and a negative effect on emotional, social, physical, and sexual function. Women can spend years trying different ways to manage UUI such as wearing pads, bladder control methods, decreasing the amount of fluid they drink, and mapping out bathrooms when they leave their home. Although there are treatment options that can help, many women suffer for years before getting treatment or can become frustrated and give up when early treatments don’t help.
Treatment for UUI first starts with conservative behavioral and pelvic floor muscle therapy, and if that doesn’t work, trying oral medications. The most common medication type usually started first is called anticholinergic medication. But if anticholinergic medications don’t help enough or cause side effects, the next best step for a woman is unknown. One option is to try a different medication class, called beta agonists. The most commonly used beta agonist is called mirabegron. Another common option is to try onabotulinumtoxinA (BTX) bladder injections. Both treatments have been shown to help UUI and are commonly used and available.
But doctors and patients don’t know which option is best for which patient because there are no studies directly comparing mirabegron and BTX. This makes decision making for patients difficult and confusing. The main goal of this study is to compare results after mirabegron versus bladder BTX injections to help patients and their doctors make more-informed decisions. The study will also examine for which patients and characteristics each treatment type works best to help patients and doctors determine the best course of treatment for an individual woman.
Who can this research help? Women and doctors can use the results from this study to decide on the next best treatment step for treating UUI (mirabegron or BTX) after unsuccessfully trying conservative and anticholinergic medication treatments.
Methods: The team includes members from five different locations across the United States. The team will enroll 432 adult women ages 18 or older who are at least very bothered by their UUI and have unsuccessfully tried conservative and anticholinergic medication treatments in the past. The team is assigning each patient by chance to receive one of the two treatments (216 in each group). Women in one group will receive mirabegron in the way it is usually prescribed by a provider. Women in the other group will receive a bladder BTX injection procedure as it is usually given by a provider. Patients will be asked to avoid starting other treatments for UUI in the first three months after starting their assigned treatment.
Patients will be enrolled into the study from either the clinics or from local communities of the five locations. A specialized community engagement team including local community leaders at the five sites will ensure the study is available to women in the communities who have not yet been able to see a specialist for their UUI. The project’s community engagement team will help deal with barriers that can prevent women from being able to get this type of UUI care and enroll in the study.
Outcomes: The team will capture outcomes every three months for a total of 12 months after starting treatment. Primary outcomes are UUI symptom severity and treatment satisfaction. Secondary outcomes are quality of life; physical, emotional, cognitive, and sexual functioning; and possible side effects and complications of treatment. These questions can be answered by filling out a paper survey or by phone interview.
Stakeholder Engagement: The research team is working with patients, healthcare providers, representatives from social support organizations across the country, an expert in insurance coverage, and community leaders to plan and conduct this study. So far, nine patients have worked closely with the study team to help design the study and choose the best ways to determine if a treatment is successful or not. This helps to ensure the study includes the things patients care about and need to know to help them make their choices. The study is set up to facilitate mutual learning and support across all team members to make sure the work is meaningful to patients and communities
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.