RiSolve App for Overactive Bladder
(APPROVE Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot have used overactive bladder medications in the past two weeks or be currently taking antibiotics for a urinary tract infection. If you are on antibiotics, you can join two weeks after finishing them.
What data supports the effectiveness of the RiSolve App treatment for overactive bladder?
How does the RiSolve App treatment for overactive bladder differ from other treatments?
The RiSolve App is unique because it likely offers a digital or app-based approach to managing overactive bladder, which is different from traditional drug treatments like solifenacin or mirabegron that work by targeting specific receptors in the body. This app-based treatment may focus on behavior modification or tracking symptoms, providing a non-pharmacological option for patients.678910
What is the purpose of this trial?
The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).
Eligibility Criteria
The APPROVE trial is for English-speaking women aged 22 or older with bothersome overactive bladder (OAB) symptoms who use mobile apps and are willing to stick to the study's treatment without seeking other therapies for 8 weeks. It excludes those planning pelvic surgeries, using catheters, with a history of certain cancers, currently on UTI medications or OAB drugs, or undergoing specific incontinence treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the RiSolve PDTx app or standard behavioral education for 8 weeks
Crossover
Participants in the control group have the option to crossover to PDTx after the initial 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- RiSolve App
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor
Foundation for Female Health Awareness (FFHA)
Collaborator