RiSolve App for Overactive Bladder

(APPROVE Trial)

Recruiting at 10 trial locations

Overseen By Patricia Moriarty

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Must not be taking: Anticholinergics, Beta-agonists, Antibiotics

Disqualifiers: Urinary incontinence, Bladder pain, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

596 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called RiSolve to determine if it can help women with overactive bladder (OAB) feel better, improve their daily life, and find the treatment satisfying. Participants will either use the app for 10 weeks or receive educational handouts to compare the two approaches. Women with bothersome OAB symptoms who use mobile apps and are willing to pause other treatments (except medications) for 8 weeks may be a good fit. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for OAB management.

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 prior data suggests that the RiSolve App is safe for treating overactive bladder?

Research shows that the RiSolve App is a digital tool designed to help manage symptoms of an overactive bladder. This smartphone app combines behavioral therapy, physical exercises, and educational content to improve bladder health.

No reports have directly linked negative effects to using the app. This is likely because the RiSolve App does not involve medication or medical procedures. Instead, it guides users through therapy and education on their phones.

The trial is labeled "Not Applicable" for the usual clinical trial phases, focusing more on the app's effectiveness rather than testing its safety like new drugs. Available on platforms like Google Play, it appears to be generally well-received by users. However, individual experiences can differ, so consulting a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RiSolve App for overactive bladder because it offers a digital therapeutic approach, which is a fresh take compared to traditional treatments like medications or physical therapy. Unlike standard therapies that often involve drugs with potential side effects or intensive pelvic floor exercises, the RiSolve App provides a personalized, app-based intervention. This allows for convenient, on-the-go bladder management and training that could fit more easily into people’s daily lives. The app’s interactive nature and potential for real-time feedback have the power to engage users more effectively, potentially enhancing adherence and outcomes.

What evidence suggests that the RiSolve App is effective for overactive bladder?

Studies have shown that the RiSolve App, available to participants in this trial, can help manage symptoms of an overactive bladder (OAB). Specifically, research found that this app significantly improved issues like urgency and mixed incontinence, making it a valuable option for managing OAB independently. The app provides an 8-week treatment plan to help reduce OAB symptoms. Research indicates that digital tools like RiSolve can effectively enhance the quality of life for those with bladder issues. Although more data is needed, early results are promising for those considering this digital treatment approach. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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

English-speaking

I am a woman aged 22 or older.

Use of at least one mobile App

Exclusion Criteria

I have not had pelvic surgery in the last 6 months.

I plan to have surgery for pelvic organ prolapse within the next year.

I am planning to get fitted for a pessary.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RiSolve PDTx app or standard behavioral education for 8 weeks

8 weeks

Crossover

Participants in the control group have the option to crossover to PDTx after the initial 8 weeks

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• RiSolve App

Trial Overview This trial compares the RiSolve App—a prescription digital therapeutic designed to improve OAB symptoms—with standard AUGS patient handouts providing behavioral education. Women will be randomly assigned to either intervention to evaluate symptom improvement and satisfaction over an 8-week period.

How Is the Trial Designed?

Group I: Intervention - RiSolve PDTx App Experimental Treatment 1 Intervention

Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.

Group II: Control - Standard Therapy Active Control 1 Intervention

Participants randomized to the control will receive a brief explanation of behavioral therapy with details provided in the form educational handouts including the American Urogynecologic Society (AUGS) "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets.

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Foundation for Female Health Awareness (FFHA)

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

In a pooled analysis of three Phase III trials involving mirabegron 50 mg for overactive bladder, the treatment showed significant improvements in both objective measures (like incontinence and micturition frequency) and patient-reported outcomes, indicating its efficacy.

The study found strong correlations between objective improvements and patient perceptions of bladder condition, suggesting that the benefits of mirabegron translate into meaningful enhancements in quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials. Castro-Diaz, D., Chapple, CR., Hakimi, Z., et al.[2019]

A pilot study involving urology clinic patients showed that a digital system for collecting patient-reported outcomes (PROs) improved workflow and communication during clinical encounters for overactive bladder (OAB) treatment.

Clinicians found the digital dashboard helpful, but it did not significantly change clinical decision-making compared to traditional methods, indicating room for further improvement in the system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical perspective on electronically collecting patient-reported outcomes at the point-of-care for overactive bladder. Desantis, D., Baverstock, RJ., Civitarese, A., et al.[2020]

In a 12-week study, solifenacin significantly improved patient-reported outcomes (PROs) for individuals with overactive bladder (OAB), particularly for those whose most bothersome symptom (MBS) was urge urinary incontinence (UUI).

Participants reported the greatest improvements in their symptoms and quality of life, with the UUI subgroup experiencing the most substantial benefits across various measures, including visual analog scales (VAS) and the OAB questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Sand, PK., Steers, WD., Dmochowski, R., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07206446?term=medical+device

Study Details | NCT07206446 | A Prospective Evaluation of ... The primary aim of the study is to assess usability of the RiSolve App, measured using the user version of the Mobile Application Rating Scale (uMARS).

2. withpower.com withpower.com/trial/risolve-app-for-overactive-bladder-55a0e

RiSolve App for Overactive Bladder (APPROVE Trial) In a 12-week study, solifenacin significantly improved patient-reported outcomes (PROs) for individuals with overactive bladder (OAB), particularly for those ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06797245

Study Details | NCT06797245 | APPROVE Trial: Evaluating ... RiSolve is indicated as an 8-week treatment to reduce the symptoms of OAB. For the purposes of this trial, the primary outcome to determine improvement in OAB- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8056293/

A Mobile App for Self-management of Urgency and Mixed ... The treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06797245/approve-trial-evaluating-a-prescription-digital-therapeutic-for-treatment-of-oab-in-women

APPROVE Trial: Evaluating a Prescription Digital ... In this trial, we will employ a randomized controlled trial design to determine if women with overactive bladder (OAB) treated with the RiSolve ...

6. play.google.com play.google.com/store/apps/details?id=com.amaratherapeutics.risolve&hl=en_US

RiSolve - Apps on Google Play RiSolve is a well-rounded program that combines behavioral therapy and physiotherapy, bladder health education, nutritional guidance, and psychology

7. ctv.veeva.com ctv.veeva.com/study/a-prospective-evaluation-of-a-prescription-digital-therapeutic-for-treatment-of-overactive-bladder-i

A Prospective Evaluation of a Prescription Digital Therapeutic ... The RiSolve Trial is a prospective, single-arm, post-market clinical investigation designed to evaluate the effectiveness, usability, ...