An interventional study of RiSolve App and AUGS Patient Handouts in Overactive Bladder (OAB), Urinary Urgency and Urinary Urge Incontinence (UUI), sponsored by Medstar Health Research Institute. Active, not recruiting at 10 sites in United States. Open to female participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
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).
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 596 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Planning to undergo pessary fitting °
https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ
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 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
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.
Overactive Bladder Questionnaire short-form (OAB-q SF)
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
Time frame: 8 Weeks
OAB-q SF Health-Related Quality of Life (HRQL)
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.
Time frame: 8 Weeks
Patient Global Impression of Severity (PGI-S)
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.
Time frame: 8 Weeks
Patient Global Impression of Improvement (PGI-I)
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.
Time frame: 8 Weeks
3-Day Bladder Diary
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.
Time frame: 8 Weeks
Questionnaire for Urinary Incontinence Diagnosis (QUID)
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.
Time frame: 8 Weeks
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
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".
Time frame: 8 Weeks
Short Personal Experience Questionnaire (SPEQ)
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.
Time frame: 8 Weeks
Mobile Application Rating Scale: user version (uMARS)
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.
Time frame: 8 Weeks
Treatment Satisfaction
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".
Time frame: 8 Weeks
Treatment accessibility
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.
Time frame: 8 Weeks
Treatment adherence
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.
Time frame: 8 Weeks
Other Treatments
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.
Time frame: 12 Months
Adverse Events
Adverse events will be assessed by querying participants regarding any adverse events that may occur throughout the trial
Time frame: 12 Months
Plan to share: No — Participant data will be collected and analyzed as an aggregate for any results.
Started Mar 2025 (actual). Primary completion is estimated for Nov 2026, 20 months after the start.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 20 months is close to that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Jul 2026 → Nov 2026 and completion Jul 2028 → Oct 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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