The burden of incontinence in a real-world data environment—insights from a digital patient companion

Au, Alexandra von; Wallwiener, Stephanie; Matthies, Lina Maria; Friedrich, Benjamin; Keim, Sabine; Wallwiener, Markus; Reisenauer, Christl; Brügger, Sarah

doi:10.1007/s00192-021-04683-4

Cited by 3 publications

(6 citation statements)

References 26 publications

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“…Study limitations include the challenges of real-world survey data. Among participants with UI, our in-app survey response rate of 50% was greater than other real-world, incontinence-related published response rates ranging from 11 to 34% [ 25 , 26 ]. Completion of the in-app UDI-6 survey is not required to use the pDTx, and users who complete the survey may differ from those who do not.…”

Section: Discussionmentioning

confidence: 69%

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data

et al. 2022

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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.

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Section: Discussionmentioning

confidence: 69%

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data

et al. 2022

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“…Some studies developed the DTs for use by women in their specific countries (eg, Sweden [ 5 ], Japan [ 68 ], and Germany [ 70 ]), and the Tät has been translated into a number of different languages [ 56 , 63 , 78 ].…”

Section: Resultsmentioning

confidence: 99%

“…Of the 19 studies that provided details about the prescribed dose, 14 (74%) recommended PFMT 3 times a day [ 5 , 6 , 41 , 47 , 50 , 52 , 54 , 56 , 60 , 63 , 64 , 68 , 73 , 78 ], 4 (21%) recommended PFMT twice a day [ 39 , 51 , 62 , 76 ], and 1 (5%) recommended it 4 times a day [ 71 ]. The most common program duration was 3 months (17/41, 41% of the studies) [ 5 , 6 , 37 - 39 , 41 , 43 , 50 , 51 , 56 , 57 , 63 , 66 , 73 - 75 , 84 ], followed by 2 months [ 47 , 49 , 52 , 54 , 58 , 59 , 68 , 71 , 76 ], with others spanning 2 to 6 weeks [ 40 , 45 , 62 , 69 , 72 ] or >15 weeks up to 6 months [ 42 , 53 , 60 , 61 , 64 , 67 ] to 1 year [ 70 ]. It should be noted that women in the study by Moossdorff-Steinhauser et al [ 52 ] continued exercising at home for at least 6 months after the end of the 8-week group exercise PFMT, and the 16 weeks specified by Jaffar et al [ 60 ] were the minimum program duration.…”

Section: Resultsmentioning

confidence: 99%

“…Publications in this area have increased rapidly since the 2010s, with most protocols registered since 2019 (Figure 2). The methodological quality was rated for 84% (38/45) of the primary studies and was predominantly high (15/38, 39%) or fair (14/38, 37%), with 24% (9/38) considered poor (Multimedia Appendix 3 [5,6,[36][37][38][39][40][41][43][44][45][46][48][49][50][51]53,[57][58][59][61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76][77]80]). Key methodological areas for consideration included blinding of participants, therapists, and outcome assessors; measuring outcomes in a valid and reliable way and identifying confounding factors (cross-sectional studies); and consecutive recruitment of participants (case series), although aspects such as double-blinding are recognized as problematic in pragmatic and clinical trials.…”

Section: Search Results and Characteristics Of The Included Studiesmentioning

confidence: 99%

“…Studies mostly recruited women with stress UI only (17/45, 38%) [5,6,[37][38][39][40][41][42][43][44][45][46][47][48][49][50][51], whereas 7% (3/45) of the studies included those with stress and mixed UI if stress symptoms were predominant [52][53][54], and 24% (11/45) included a mixture of stress, urge, and mixed UI types [55][56][57][58][59][60][61][62][63][64][65]. In total, 11% (5/45) of the studies included healthy (continent) and incontinent participants [66][67][68][69][70], and 11% (5/45) did not clearly specify the UI type [71][72][73][74][75], and this was irrelevant in 7% (3/45) [36,70,80]. Only 2% (1/45) of the studies [76], a case study, looked at urge UI only.…”

Section: Ui In the Included Studiesmentioning

confidence: 99%

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Digital Technologies for Women’s Pelvic Floor Muscle Training to Manage Urinary Incontinence Across Their Life Course: Scoping Review

Woodley¹,

Moller²,

Clark³

et al. 2023

JMIR Mhealth Uhealth

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Background Women with urinary incontinence (UI) may consider using digital technologies (DTs) to guide pelvic floor muscle training (PFMT) to help manage their symptoms. DTs that deliver PFMT programs are readily available, yet uncertainty exists regarding whether they are scientifically valid, appropriate, and culturally relevant and meet the needs of women at specific life stages. Objective This scoping review aims to provide a narrative synthesis of DTs used for PFMT to manage UI in women across their life course. Methods This scoping review was conducted in accordance with the Joanna Briggs Institute methodological framework. A systematic search of 7 electronic databases was conducted, and primary quantitative and qualitative research and gray literature publications were considered. Studies were eligible if they focused on women with or without UI who had engaged with DTs for PFMT, reported on outcomes related to the use of PFMT DTs for managing UI, or explored users’ experiences of DTs for PFMT. The identified studies were screened for eligibility. Data on the evidence base for and features of PFMT DTs using the Consensus on Exercise Reporting Template for PFMT, PFMT DT outcomes (eg, UI symptoms, quality of life, adherence, and satisfaction), life stage and culture, and the experiences of women and health care providers (facilitators and barriers) were extracted and synthesized by ≥2 independent reviewers. Results In total, 89 papers were included (n=45, 51% primary and n=44, 49% supplementary) involving studies from 14 countries. A total of 28 types of DTs were used in 41 primary studies, including mobile apps with or without a portable vaginal biofeedback or accelerometer-based device, a smartphone messaging system, internet-based programs, and videoconferencing. Approximately half (22/41, 54%) of the studies provided evidence for or testing of the DTs, and a similar proportion of PFMT programs were drawn from or adapted from a known evidence base. Although PFMT parameters and program compliance varied, most studies that reported on UI symptoms showed improved outcomes, and women were generally satisfied with this treatment approach. With respect to life stage, pregnancy and the postpartum period were the most common focus, with more evidence needed for women of various age ranges (eg, adolescent and older women), including their cultural context, which is a factor that is rarely considered. Women’s perceptions and experiences are often considered in the development of DTs, with qualitative data highlighting factors that are usually both facilitators and barriers. Conclusions DTs are a growing mechanism for delivering PFMT, as evidenced by the recent increase in publications. This review highlighted the heterogeneity in types of DTs, PFMT protocols, the lack of cultural adaptations of most of the DTs reviewed, and a paucity in the consideration of the changing needs of women across their life course.

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Digital Technologies for Women’s Pelvic Floor Muscle Training to Manage Urinary Incontinence Across Their Life Course: Scoping Review (Preprint)

Woodley¹,

Moller²,

Clark³

et al. 2022

Preprint

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BACKGROUND Women with urinary incontinence (UI) may consider using digital technologies (DTs) to guide pelvic floor muscle training (PFMT) to help manage their symptoms. DTs that deliver PFMT programs are readily available, yet uncertainty exists regarding whether they are scientifically valid, appropriate, and culturally relevant and meet the needs of women at specific life stages. OBJECTIVE This scoping review aims to provide a narrative synthesis of DTs used for PFMT to manage UI in women across their life course. METHODS This scoping review was conducted in accordance with the Joanna Briggs Institute methodological framework. A systematic search of 7 electronic databases was conducted, and primary quantitative and qualitative research and gray literature publications were considered. Studies were eligible if they focused on women with or without UI who had engaged with DTs for PFMT, reported on outcomes related to the use of PFMT DTs for managing UI, or explored users’ experiences of DTs for PFMT. The identified studies were screened for eligibility. Data on the evidence base for and features of PFMT DTs using the Consensus on Exercise Reporting Template for PFMT, PFMT DT outcomes (eg, UI symptoms, quality of life, adherence, and satisfaction), life stage and culture, and the experiences of women and health care providers (facilitators and barriers) were extracted and synthesized by ≥2 independent reviewers. RESULTS In total, 89 papers were included (n=45, 51% primary and n=44, 49% supplementary) involving studies from 14 countries. A total of 28 types of DTs were used in 41 primary studies, including mobile apps with or without a portable vaginal biofeedback or accelerometer-based device, a smartphone messaging system, internet-based programs, and videoconferencing. Approximately half (22/41, 54%) of the studies provided evidence for or testing of the DTs, and a similar proportion of PFMT programs were drawn from or adapted from a known evidence base. Although PFMT parameters and program compliance varied, most studies that reported on UI symptoms showed improved outcomes, and women were generally satisfied with this treatment approach. With respect to life stage, pregnancy and the postpartum period were the most common focus, with more evidence needed for women of various age ranges (eg, adolescent and older women), including their cultural context, which is a factor that is rarely considered. Women’s perceptions and experiences are often considered in the development of DTs, with qualitative data highlighting factors that are usually both facilitators and barriers. CONCLUSIONS DTs are a growing mechanism for delivering PFMT, as evidenced by the recent increase in publications. This review highlighted the heterogeneity in types of DTs, PFMT protocols, the lack of cultural adaptations of most of the DTs reviewed, and a paucity in the consideration of the changing needs of women across their life course. CLINICALTRIAL

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The burden of incontinence in a real-world data environment—insights from a digital patient companion

Cited by 3 publications

References 26 publications

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data

A digital health program for treatment of urinary incontinence: retrospective review of real-world user data

Digital Technologies for Women’s Pelvic Floor Muscle Training to Manage Urinary Incontinence Across Their Life Course: Scoping Review

Digital Technologies for Women’s Pelvic Floor Muscle Training to Manage Urinary Incontinence Across Their Life Course: Scoping Review (Preprint)

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