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| Name | Class |
|---|---|
| Foundation for Female Health Awareness (FFHA) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - RiSolve PDTx App | Experimental | Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation. |
|
| Control - Standard Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RiSolve App | Device | Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 Weeks |
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Inclusion Criteria:
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 °
https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Moriarty | Contact | 202-877-0486 | approvetrial@medstar.net | |
| Alexis Dieter, MD | Contact | 202-877-6526 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20410783 | Background | Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available. | |
| 18929686 | Background | Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. |
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Participant data will be collected and analyzed as an aggregate for any results.
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| AUGS Patient Handouts | Behavioral | AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed. |
|
| 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. |
| 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. | 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. | 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. | 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". | 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. | 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. | 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". | 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. | 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. | 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. | 12 Months |
| Adverse Events | Adverse events will be assessed by querying participants regarding any adverse events that may occur throughout the trial | 12 Months |
| Stanford University | Recruiting | Palo Alto | California | 94304 | United States |
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| MedStar Health | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Curavit | Active, not recruiting | Boston | Massachusetts | 02116 | United States |
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
|
| Allegheny Health | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
|
| Medical University of South Carolina Health | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53715 | United States |
|
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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