Overactive Bladder (OAB)APPROVENCT06797245
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
A study testing RiSolve App and AUGS Patient Handouts in people with Overactive Bladder (OAB) and Urinary Urgency, run by Medstar Health Research Institute at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Urinary Urgency, Urinary Urge Incontinence (UUI)
- What is being tested?
- RiSolve App and AUGS Patient Handouts
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Mar 2025to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexis Dieter, MD contact
10 sites in 1 country
United States10 sites, 9 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Elizabeth Kilpatrick, 205-801-5830, ekilpatrick@uabmc.edu
Gabriela Halder, MD
- Active, not recruiting
Curavit
Boston, Massachusetts, 02116
- Recruiting
Medical University of South Carolina Health
Charleston, South Carolina, 29425
Payne, 843-792-7525, paynej@musc.edu
Amy Askew, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Samsel, 773-795-8777, tara.samsel@bsd.uchicago.edu
Margaret Mueller, MD
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Agnes Burris, RN, 214-645-3833, agnes.burris@utsouthwestern.edu
Maria E. Florian-Rodriguez, MD, FACOG
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53715
Rosenbaum, 608-263-6240, lrosenbaum2@wisc.edu
Jon Pennycuff, MD
- Recruiting
Stanford University
Palo Alto, California, 94304
Shyairra Dodd, 650-497-5175, gynresearch@stanford.edu
Eric Sokol, MD
- Recruiting
Allegheny Health
Pittsburgh, Pennsylvania, 15224
Winkelman, 412-578-4368, Monica.Winkelman@ahn.org
Erin Lavelle, MD
- Recruiting
MedStar Health
Washington D.C., District of Columbia, 20010
Kendra Green, (202) 997-4536, kendra.s.green@medstar.net
Robert Gutman, MD
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103
Vyas, 3336-713-4098, svyas@wakehealth.edu
Candace Parker-Autry, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Overactive Bladder (OAB), Urinary Urgency, Urinary Urge Incontinence (UUI), Nocturia, Urinary Frequency
- Being tested
- RiSolve App, AUGS Patient Handouts
- Keywords
- Overactive Bladder (OAB)
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiSolve AppDevice
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
AUGS Patient HandoutsBehavioural
AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - RiSolve PDTx App | Experimental | Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation. Receives: Device: RiSolve App |
| 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. Receives: Behavioral: AUGS Patient Handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 Weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Adverse Events
Adverse events will be assessed by querying participants regarding any adverse events that may occur throughout the trial
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start17 Mar 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Female Health Awareness
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797245
- Sponsor's protocol ID
- APPROVE
- Acronym
- APPROVE
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be collected and analyzed as an aggregate for any results.
Publications
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.
PubMed 20410783Harris 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.
PubMed 18929686Rubin D. Multiple Imputation for Nonresponse in Surveys. New York: John Wiley & Sons, Inc.; 1987.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
PubMed 31078660Coyne KS, Thompson CL, Lai JS, Sexton CC. An overactive bladder symptom and health-related quality of life short-form: validation of the OAB-q SF. Neurourol Urodyn. 2015 Mar;34(3):255-63. doi: 10.1002/nau.22559. Epub 2014 Jan 13.
PubMed 25783168Burkett LS, Siddique M, Zeymo A, Brunn EA, Gutman RE, Park AJ, Iglesia CB. Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):968-978. doi: 10.1097/AOG.0000000000004332.
PubMed 33957642Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
PubMed 27287964Dennerstein L, Lehert P, Dudley E. Short scale to measure female sexuality: adapted from McCoy Female Sexuality Questionnaire. J Sex Marital Ther. 2001 Jul-Sep;27(4):339-51. doi: 10.1080/009262301317081098.
PubMed 11441518Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Am J Obstet Gynecol. 2004 Jul;191(1):73-82. doi: 10.1016/j.ajog.2003.12.027.
PubMed 15295345Bradley CS, Rovner ES, Morgan MA, Berlin M, Novi JM, Shea JA, Arya LA. A new questionnaire for urinary incontinence diagnosis in women: development and testing. Am J Obstet Gynecol. 2005 Jan;192(1):66-73. doi: 10.1016/j.ajog.2004.07.037.
PubMed 15672005Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, Siddiqui NY, Abel RB, Spino C, Richter HE. The questionnaire for urinary incontinence diagnosis (QUID): validity and responsiveness to change in women undergoing non-surgical therapies for treatment of stress predominant urinary incontinence. Neurourol Urodyn. 2010 Jun;29(5):727-34. doi: 10.1002/nau.20818.
PubMed 19787711Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
PubMed 12861145Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
PubMed 12206577Sanderson DJ, Zavez A, Meekins AR, Eddib A, Lee TG, Barber MD, Duecy E. The Patient Acceptable Symptom State in Female Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):33-39. doi: 10.1097/SPV.0000000000001055.
PubMed 34009829