APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women (APPROVE)

October 24, 2025 updated by: Medstar Health Research Institute

The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this trial, we will employ a randomized controlled trial design to determine if women with overactive bladder (OAB) treated with the RiSolve prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts. RiSolve is a digital therapeutic device intended to provide behavioral therapy and cognitive behavioral therapy (CBT) for adult women who have been diagnosed with OAB, which includes urinary urgency with or without urge urinary incontinence (UUI), urinary frequency, nocturia, and mixed incontinence with predominant OAB symptoms. 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-related health will be defined as achieving the MID (defined as an improvement of 10 points or more) on the OAB-q SF Symptom Severity subscale after 8 weeks of treatment. Secondary outcomes will include achieving the MID on the OAB-q SF Health-Related Quality of Life subscale, meeting the patient's acceptable symptoms state (PASS) on the Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I), and improvements in frequency, nocturia and urge urinary incontinence (UUI) on a 3-day bladder diary and on the ICIQ-FLUTS. Participants will be randomized to either PDTx therapy (active) or standard treatment of behavioral education (control). Participants randomized to control will have the option to crossover to PDTx after the initial 8 weeks of the trial if desired. Participants will continue to be followed and asked about their symptoms at 6 and 12 months.

The impact of this trial has enormous potential to improve treatment of OAB. The ability to offer behavioral therapy via PDTx will reduce patient burden while simultaneously increasing quality of life for women suffering from OAB and decreasing provider burden. The high-quality data from this study will be used to support a marketing application with the FDA through the De Novo pathway for an accessible, low-burden, efficient intervention to help millions of women currently suffering from this burdensome condition.

Study Type

Interventional

Enrollment (Estimated)

596

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alexis Dieter, MD
  • Phone Number: 202-877-6526

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham
        • Sub-Investigator:
          • Holly Richter, MD
        • Sub-Investigator:
          • David Ellington, MD
        • Sub-Investigator:
          • Thomas Powell, MD
        • Sub-Investigator:
          • Gena Dunivan, MD
        • Principal Investigator:
          • Gabriela Halder, MD
        • Contact:
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Eric Sokol, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health
        • Sub-Investigator:
          • Cheryl Iglesia, MD
        • Principal Investigator:
          • Robert Gutman, MD
        • Contact:
        • Sub-Investigator:
          • Lee Ann Richter, MD
        • Sub-Investigator:
          • Andrew Sokol, MD
        • Sub-Investigator:
          • Alexis Dieter, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Margaret Mueller, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Active, not recruiting
        • Curavit
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Atrium Health Wake Forest Baptist
        • Principal Investigator:
          • Candace Parker-Autry, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Allegheny Health
        • Contact:
        • Principal Investigator:
          • Erin Lavelle, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina Health
        • Contact:
        • Principal Investigator:
          • Amy Askew, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Maria E. Florian-Rodriguez, MD, FACOG
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • Jon Pennycuff, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women ≥ 22 years old
  • Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)
  • English-speaking
  • Willing to forego other treatment outside of medications for the 8-week trial period
  • Use of at least one mobile App

Exclusion Criteria:

  • Stress-predominant mixed urinary incontinence (defined as QUID stress score > QUID urge score)
  • Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a
  • Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a
  • Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks
  • Currently using intermittent or indwelling catheter
  • History of bladder/urethral, colon/anal, or cervical cancer
  • Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection
  • Currently taking antibiotics/drugs for urinary tract infection^
  • Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period
  • Planning surgery for pelvic organ prolapse within 12 months of randomization
  • Pelvic surgery within the past 6 months

  • Planning to undergo pessary fitting °

    • Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting

https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - RiSolve PDTx App
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
Device: RiSolve App
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
Active Comparator: Control - Standard Therapy
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.
Behavioral: AUGS Patient Handouts
AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive Bladder Questionnaire short-form (OAB-q SF)
Time Frame: 8 Weeks
The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life,35 and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during anticholinergic therapy.3 The scale ranges from 0 to 100 with a higher score indicating worse symptom severity. The MID is defined as a change of 10 points
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OAB-q SF Health-Related Quality of Life (HRQL)
Time Frame: 8 Weeks
The OAB-q SF Health-Related Quality of Life (HRQL) subscale is a13-item health-related quality of life subscale of the OAB-q SF. The scale ranges from 0 to 100 with a higher score indicating better quality of life. The MID is defined as a change of 10 points.
8 Weeks
Patient Global Impression of Severity (PGI-S)
Time Frame: 8 Weeks
Patient Global Impression of Severity (PGI-S) is a single item questionnaire to assess a person's impression of disease severity. For purposes of this trial, it will ask participants to "Check the one number that best describes how your urinary tract condition is now" on a 4-point Likert scale ranging from (1) "normal" to (4) "severe". The PASS threshold PGI-S score is < 3.
8 Weeks
Patient Global Impression of Improvement (PGI-I)
Time Frame: 8 Weeks
The Patient Global Impression of Improvement (PGI-I) is a single item questionnaire to assess an individual's impression of change in urinary symptoms. For purposes of this trial the PGI-S has been adapted by removing "taking medication" and it will ask participants to "Check the one number that best describes how your urinary tract condition is now, compared with how it was before you began this study" on a 7-point Likert scale ranging from (1) "very much better" to (7) "very much worse". The PASS threshold PGI-I score is < 3.
8 Weeks
3-Day Bladder Diary
Time Frame: 8 Weeks
A 3-day Bladder Diary will be an electronic bladder diary collected over a 3-day (72 hour) period focusing specifically on number of voids per day, number of voids per night, and number of urinary incontinence (UI) episodes and whether these events are associated with urgency.
8 Weeks
Questionnaire for Urinary Incontinence Diagnosis (QUID)
Time Frame: 8 Weeks
The Questionnaire for Urinary Incontinence Diagnosis (QUID) is a 6-item UI symptom questionnaire to distinguish stress and urgency UI. The QUID serves both as a diagnostic tool to assess UI type and as a measure of SUI and UUI frequency before and after treatment. Prior research has shown that a cut off QUID stress score ≥ 4 and QUID urge score ≥ 6 identify UI type (SUI, UUI or mixed) accurately in 80% of patients as compared to provider diagnosis.
8 Weeks
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time Frame: 8 Weeks
The International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) is a 12-item questionnaire to evaluate female lower urinary tract symptoms and impact on quality of life derived from the BFLUTS-SF questionnaire. The ICIQ-FLUTS asks each person to rate the frequency of a specific lower urinary tract symptom (such as urgency, frequency, nocturia, nocturnal enuresis, stress incontinence, pain, etc.) on various 5 point scales and then asks the participant to rate the level of bother from that specific symptom on a Likert scale from (0) "not at all" to (10) "a great deal".
8 Weeks
Short Personal Experience Questionnaire (SPEQ)
Time Frame: 8 Weeks
The Short Personal Experience Questionnaire (SPEQ) is a 13-item questionnaire that assesses sexual enjoyment, desire, arousal, orgasm, dyspareunia, sexual activity, sexual partner, and partner limitations. To limit participant burden, the SPEQ has been modified to a shorter 8-item version to include fewer items on partner limitations.
8 Weeks
Mobile Application Rating Scale: user version (uMARS)
Time Frame: 8 Weeks
The Mobile Application Rating Scale: user version (uMARS) is comprised of a 20-item objective quality rating with 4 subscales (engagement, functionality, aesthetics, and information quality), and 6-item subjective quality rating. Higher scores are more desirable. Participants randomized to or who crossover to PDTx treatment will be asked to complete the uMARS questionnaire 8 weeks after starting PDTx treatment. A uMARS score of ≥ 3 is considered acceptable.
8 Weeks
Treatment Satisfaction
Time Frame: 8 Weeks
Treatment satisfaction will be assessed by asking participants to "Rate your level of satisfaction with the study treatment" they received on a 5-point Likert scale ranging from (1) "very satisfied" to (5) "very dissatisfied".
8 Weeks
Treatment accessibility
Time Frame: 8 Weeks
Treatment accessibility will be assessed by recording the number of participants who are unable to or have difficulty accessing the App and any phone calls/tech support requests.
8 Weeks
Treatment adherence
Time Frame: 8 Weeks
Treatment adherence for participants receiving PDTx treatment will be assessed via App usage data. For the control group direct questioning will be used to assess treatment adherence (Did you read the leaflet? Answer choices: Yes / No. If yes, how much of it did you read? With answer choices in % categories; If yes, did you return to the leaflet during the 8 weeks to refresh your memory? Answer choices: Yes / No). For those prescribed an anticholinergic or beta-agonist medication we will assess medication compliance through direct patient questioning to assess if the medication was obtained from the pharmacy, how long the medication was taken, any side effects, and, if applicable, the reason for stopping the medication.
8 Weeks
Other Treatments
Time Frame: 12 Months
Other treatments will be assessed following the initial 8-week intervention period by querying participants as to whether they have any new conditions or are using or have tried using additional treatments that could affect OAB symptoms. These will include assessing for diagnosis of and treatment for stress urinary incontinence, urinary retention, pelvic organ prolapse, genitourinary syndrome of menopause, vaginal atrophy, pregnancy, sleep apnea, heart failure, and diabetes.
12 Months
Adverse Events
Time Frame: 12 Months
Adverse events will be assessed by querying participants regarding any adverse events that may occur throughout the trial
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Foundation for Female Health Awareness (FFHA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPROVE (Yining Huang)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data will be collected and analyzed as an aggregate for any results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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