596 Participants Needed

RiSolve App for Overactive Bladder

(APPROVE Trial)

Recruiting at 1 trial location
MG
AD
Overseen ByAlexis Dieter, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research does not provide direct evidence of the RiSolve App's effectiveness for overactive bladder, but it mentions the development of a mobile application to aid in treatment decisions, which suggests a focus on improving patient engagement and decision-making.12345

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

English-speaking
I am a woman aged 22 or older.
Use of at least one mobile App
See 2 more

Exclusion Criteria

I plan to have surgery for pelvic organ prolapse within the next year.
I have not had pelvic surgery in the last 6 months.
I am planning to get fitted for a pessary.
See 11 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - RiSolve PDTx AppExperimental Treatment1 Intervention
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
Group II: Control - Standard TherapyActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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 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.
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]

References

Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. [2021]
A Mobile Application Patient Decision Aid for Treatment of Overactive Bladder. [2022]
Treatment patterns in women with urinary urgency and/or urgency urinary incontinence in the symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study. [2023]
A clinical perspective on electronically collecting patient-reported outcomes at the point-of-care for overactive bladder. [2020]
Development of a predictive model for urgency urinary incontinence. [2018]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Comprehensive pharmacologic management of overactive bladder]. [2019]
Higher urge severity score predicts resumption of overactive bladder (OAB) medication following discontinuation of mirabegron treatment in patients with OAB. [2019]
Turkish validation of the overactive bladder symptom score (OABSS) and evaluation of mirabegron treatment response. [2020]
Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder-Wet. [2020]
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. [2019]
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