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Introduction and hypothesis: To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. Methods: This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020–December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. Results: Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22–84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2–46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. Conclusions: This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period. [ABSTRACT FROM AUTHOR]

Aims: The objective of this analysis was to describe longitudinal adherence with recommended urinary incontinence (UI) evaluation and treatment guidelines over a 2‐year period in patients newly diagnosed with stress (SUI) or mixed UI (MUI), and average 2‐year cost associated with initial treatment. Methods: A retrospective claims analysis using the IBM MarketScan database was conducted. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using the International Classification of Diseases (ICD) 9 and 10 codes for SUI or MUI. Newly diagnosed SUI/MUI patients who did not have a UI‐related diagnosis for at least 1 year before their index date were assessed. Results: 103 813 patients with newly diagnosed SUI or MUI were identified. Of those, 96.15% (99 821/103 813) received an initial evaluation in accordance with professional guidelines (e.g., patient history, physical examination, urinalysis). Only 6.8% (5086/74 925) and 7.7% (2229/28 888) of patients with SUI and MUI, respectively, received a first‐line behavioral treatment (e.g., pelvic floor muscle exercises, bladder training), according to guidelines. The 2‐year average UI‐related medical costs associated with guideline adherence for SUI were $5770.93 ± $9454.81 and for MUI, $4416.16 ± $7401.53. Nonadherence was observed in 59.2% (44 382/74 925) of SUI and 64.1% (18 530/28 888) of MUI patients. Two‐year average UI‐related medical costs for the nonadherent group were $8568.00 ± $11 275.52 for SUI and $6986.66 ± $10 765.55 for MUI, significantly more than the adherent group (p < 0.0001). Conclusion: The majority of SUI or MUI patients do not receive a documented behavioral intervention as their first‐line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for payers; those that were nonadherent had significantly higher costs 2‐year postindex. [ABSTRACT FROM AUTHOR]

Aims: There is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion‐based VBF device and app was effective for at‐home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms. Methods: A single‐arm 10‐week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2‐week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed‐rank test. Results: Of 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10‐weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052). Conclusions: In this pilot study, there was significant improvement in FI symptom‐specific severity and quality of life using a vaginal, motion‐based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting. [ABSTRACT FROM AUTHOR]

To compare the efficacy of an Intravaginal Motion-Based Digital Health System (PDHS) compared to standardized Pelvic Floor Muscle Training (PFMT) for the treatment of stress or stress-predominant urinary incontinence (SUI). This is a virtually conducted prospective randomized controlled trial. The primary outcomes are change in urinary incontinence episodes by 3-day bladder diary and change in Urogenital Distress Inventory-6 score, measured at 8 weeks. Secondary outcomes include: Patient Global Impression of Severity (PGI-S), PGI-Improvement (PGI-I), Pelvic Floor Distress Inventory-20(PFDI-20), Pelvic Floor Impact Questionnaire-7(PFIQ-7), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-IR), Short Form-2 (SF-20), and assessment of adverse event (AE). Subjects are randomized 1:1 to an intervention group using leva PDHS for PFMT or a control group, using a home Kegel exercise program. Sample size needed to identify a 60% difference in incontinence episodes from baseline to 8 weeks post-randomization using alpha = 0.05, and a power of 0.8 is 156 subjects. To identify a 30% difference in the UDI-6 score from Baseline to Week 8 (alpha = 0.05, power = 0.8, using a one-tailed t -test) the needed sample size is 278, and allowing for an attrition rate of 15%, will require approximately 350 subjects, providing power to detect differences in both primary outcomes. Recruitment was initiated September 2020 and is on target to date. The trial is projected to be complete in 2021and is registered at clinicaltrials.gov NCT04508153. This novel virtual recruitment approach may provide more efficient recruitment of large numbers of subjects and provide input into the use of app-based management of pelvic floor interventions. • Design of an all-remote randomized controlled trial for stress urinary incontinence treatment. • Use of an app and device to treat stress urinary incontinence- a design for remote research. • Intravaginal motion based digital therapeutic device for pelvic floor muscle training. [ABSTRACT FROM AUTHOR]