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

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

Overview

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).

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.

Interventions

• Device RiSolve App
  Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
• Behavioral AUGS Patient Handouts
  AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.

Primary outcome measures

• Overactive Bladder Questionnaire short-form (OAB-q SF) [Time frame: 8 Weeks]

Secondary outcome measures (12)

• OAB-q SF Health-Related Quality of Life (HRQL) [Time frame: 8 Weeks]
• Patient Global Impression of Severity (PGI-S) [Time frame: 8 Weeks]
• Patient Global Impression of Improvement (PGI-I) [Time frame: 8 Weeks]
• 3-Day Bladder Diary [Time frame: 8 Weeks]
• Questionnaire for Urinary Incontinence Diagnosis (QUID) [Time frame: 8 Weeks]
• International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) [Time frame: 8 Weeks]
• Short Personal Experience Questionnaire (SPEQ) [Time frame: 8 Weeks]
• Mobile Application Rating Scale: user version (uMARS) [Time frame: 8 Weeks]
• Treatment Satisfaction [Time frame: 8 Weeks]
• Treatment accessibility [Time frame: 8 Weeks]
• Treatment adherence [Time frame: 8 Weeks]
• Other Treatments [Time frame: 12 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 10 centers

• University of Alabama at Birmingham — Birmingham
• Stanford University — Palo Alto
• MedStar Health — Washington D.C.
• University of Chicago — Chicago
• Curavit — Boston
• Atrium Health Wake Forest Baptist — Winston-Salem
• Allegheny Health — Pittsburgh
• Medical University of South Carolina Health — Charleston
• … and 2 more centers

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. PMID 20410783
• 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. PMID 18929686
• Rubin 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. PMID 31078660
• Coyne 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. PMID 25783168
• Burkett 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. PMID 33957642
• Stoyanov 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. PMID 27287964
• Dennerstein 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. PMID 11441518

Identifiers

NCT: NCT06797245 · APPROVE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗