Dataset Information

Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

ABSTRACT: BACKGROUND:Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app. OBJECTIVE:The objective of this study was to evaluate the health economy of the app for treating SUI. METHODS:This deterministic cost-utility analysis, with a 1-year societal perspective, compared the app treatment with no treatment. Health economic data were collected alongside a randomized controlled trial performed in Sweden from March 2013 to October 2014. This study included 123 community-dwelling women participants of 18 years and above, with stress urinary incontinence ?1 time per week. Participants were self-assessed with validated questionnaires and 2-day leakage diaries, and then randomized to 3 months of treatment (app group, n=62) or no treatment (controls, n=61). The app focused on pelvic floor muscle training, prescribed 3 times daily. We continuously registered treatment delivery costs. Data were collected on each participant's training time, incontinence aids, and laundry at baseline and at a 3-month follow-up. We measured quality of life with the International Consultation on Incontinence Modular Questionnaire on Lower Urinary Tract Symptoms and Quality of Life, and calculated the quality-adjusted life years (QALYs) gained. Data from the 3-month follow-up were extrapolated to 1 year for the calculations. Our main outcome was the incremental cost-effectiveness ratios compared between app and control groups. One-way and multiway sensitivity analyses were performed. RESULTS:The mean age of participants was 44.7 years (SD 9.4). Annual costs were €547.0 for the app group and €482.4 for the control group. Annual gains in quality-adjusted life years for app and control groups were 0.0101 and 0.0016, respectively. Compared with controls, the extra cost per quality-adjusted life year for the app group ranged from -€2425.7 to €14,870.6, which indicated greater gains in quality-adjusted life years at similar or slightly higher cost. CONCLUSIONS:The app for treating stress urinary incontinence is a new, cost-effective, first-line treatment with potential for increasing access to care in a sustainable way for this patient group.

SUBMITTER: Sjostrom M

PROVIDER: S-EPMC5440735 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

Sjöström Malin M Lindholm Lars L Samuelsson Eva E

Journal of medical Internet research 20170508 5

<h4>Background</h4>Mobile apps can increase access to care, facilitate self-management, and improve adherence to treatment. Stress urinary incontinence (SUI) affects 10-35% of women and, currently, an app with instructions for pelvic floor muscle training (PFMT) is available as first-line treatment. A previous randomized controlled study demonstrated that the app benefitted symptom severity and quality of life (QoL); in this study we investigate the cost-effectiveness of the app.<h4>Objective</h ...[more]

PMID: 28483745

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Project description:BackgroundStress urinary incontinence (SUI) is a common source of distress among women during and after pregnancy. It has a negative effect on quality of life but with poor care-seeking. Mobile health (mHealth) may be a promising solution with potential advantages. However, there is uncertainty whether a mobile app is effective for SUI symptom improvement during and after pregnancy. The implementation is also unclear. We developed an app named UIW (Urinary Incontinence for Women) aimed at improving perinatal incontinence.ObjectiveThe objective of this study is to evaluate the effectiveness of the UIW app-based intervention in improving SUI symptoms among pregnant women and explore the facilitators and barriers to using the UIW app to help refine and optimize the intervention.MethodsThis study is a hybrid effectiveness-implementation trial with a randomized controlled trial alongside a mixed-methods process evaluation according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Pregnant women with SUI (n=336) will be recruited from a university-affiliated hospital in China. They will be randomly allocated (1:1) to either the intervention group that receive usual care plus UIW app or control group that receive usual care alone. The intervention period will last 2 months. The 5 dimensions of the RE-AIM framework will be evaluated at recruitment (-T1), baseline (T0), immediately after intervention (T1), 42 days after delivery (T2), 3 months after delivery (T3), and 6 months after delivery (T4) through project documents, online questionnaires and a pelvic floor muscle training diary, surface electromyography, log data in the background management system, and qualitative interviews. Data analysis will follow the intention-to-treat principle. Descriptive statistics, t tests, chi-square tests, and a linear mixed model will be used to analyze the quantitative data. Deductive and inductive content analysis will be used to analyze the qualitative data.ResultsThe effectiveness-implementation trial started in June 2020, trial recruitment was completed in October 2020, and the intervention will last for a 2-month period. Completion of the 6-month follow-up will be in July 2021, and we anticipate that the results of this study will be published in December 2021.ConclusionsThis study will evaluate both effectiveness and implementation of the UIW app-based intervention among pregnant women. The hybrid effectiveness-implementation trial design according to the RE-AIM framework with a mixed-methods approach will give valuable insights into the effects as well as facilitators and barriers to the implementation that will influence the effects of the UIW app-based intervention.Trial registrationChinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.International registered report identifier (irrid)PRR1-10.2196/22771.

Project description:ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24?602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months' use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

Project description:BackgroundStress urinary incontinence (SUI) affects 10%-39% of women. Its first-line treatment consists of lifestyle interventions and pelvic floor muscle training (PFMT), which can be performed supervised or unsupervised. Health apps are increasing in number and can be used to improve adherence to treatments. We developed the Tät app, which provides a 3-month treatment program with a focus on PFMT for women with SUI. The app treatment was evaluated in a randomized controlled trial, which demonstrated efficacy for improving incontinence symptoms and quality of life. In this qualitative interview study, we investigated participant experiences of the app-based treatment.ObjectiveThis study aimed to explore women's experiences of using an app-based treatment program for SUI.MethodsThis qualitative study is based on telephone interviews with 15 selected women, with a mean age of 47 years, who had used the app in the previous randomized controlled trial. A semistructured interview guide with open-ended questions was used, and the interviews were transcribed verbatim. Data were analyzed according to the grounded theory.ResultsThe results were grouped into three categories: "Something new!" "Keeping motivation up!" and "Good enough?" A core category, "Enabling my independence," was identified. The participants appreciated having a new and modern way to access a treatment program for SUI. The use of new technology seemed to make incontinence treatment feel more prioritized and less embarrassing for the subjects. The closeness to their mobile phone and app features like reminders and visual graphs helped support and motivate the women to carry through the PFMT. The participants felt confident that they could perform the treatment program on their own, even though they expressed some uncertainty about whether they were doing the pelvic floor muscle contractions correctly. They felt that the app-based treatment increased their self-confidence and enabled them to take responsibility for their treatment.ConclusionsUse of the app-based treatment program for SUI empowered the women in this study and helped them self-manage their incontinence treatment. They appreciated the app as a new tool for supporting their motivation to carry through a slightly challenging PFMT program.Trial registrationClinicalTrials.gov NCT01848938; https://clinicaltrials.gov/ct2/show/NCT01848938 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01848938).

Project description:BackgroundMany women experience urgency (UUI) and mixed (MUI) urinary incontinence but commonly hesitate to seek care. Treatment access and self-management for these conditions can be supported through eHealth approaches.ObjectiveThis study aimed to investigate the efficacy of the mobile app Tät II for self-management of UUI and MUI in women.MethodsThis randomized controlled trial included women ≥18 years old with UUI or MUI and ≥2 leakages per week. Those with red-flag symptoms were excluded. Participants were recruited via analog and digital advertisements and screened for initial selection through a web-based questionnaire. Data were collected using another questionnaire and a 2-day bladder diary. A telephone interview confirmed the symptom diagnosis. Participants were randomized (1:1) to receive access to a treatment app (including pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, tailored advice, exercise log, reinforcement messages, and reminders) or an information app (control group), with no external treatment guidance provided. The primary outcome was incontinence symptoms at the 15-week follow-up, measured using the International Consultation on Incontinence Questionnaire (ICIQ)-Urinary Incontinence Short Form (ICIQ-UI SF). Urgency symptoms were assessed using the ICIQ-Overactive Bladder Module (ICIQ-OAB) and quality of life using the ICIQ-Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). Incontinence episode frequency (IEF) was calculated per bladder diary entries. Improvement was measured using the Patient's Global Impression of Improvement. All outcomes were self-reported. Cure was defined as no leakages per the bladder diary. Intention-to-treat analysis was performed.ResultsBetween April 2017 and March 2018, 123 women (mean age 58.3, SD 9.6 years) were randomized to the treatment (n=60, 2 lost to follow-up) or information (n=63) group. Of these, 35 (28%) women had UUI, and 88 (72%) had MUI. Mean ICIQ-UI SF score at follow-up was lower in the treatment group than in the information group (estimated difference -3.1, 95% CI -4.8 to -1.3). The estimated between-group difference was -1.8 (95% CI -2.8 to -0.99) for mean ICIQ-OAB score and -6.3 (95% CI -10.5 to -2.1) for the mean ICIQ-LUTSqol score at follow-up. IEF reduction from baseline to follow-up was greater in the treatment group (-10.5, IQR -17.5 to -3.5) than in the information group (P<.001). Improvement was reported by 87% (52/60) of treatment group participants and by 30% (19/63) of information group participants. The cure rate was 32% in the treatment group, and 6% in the information group (odds ratio 5.4, 95% CI 1.9-15.6; P=.002). About 67% (40/60) of the treatment group participants used the app more than thrice a week.ConclusionsThe treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative to pharmacological treatment or other conservative management, thus increasing access to care.Trial registrationClinicalTrials.gov NCT03097549; https://clinicaltrials.gov/ct2/show/NCT03097549.

Project description:The aim of this study was to evaluate the cost-effectiveness of a behavioral intervention for urinary incontinence of prostate cancer patients. Study subjects were either participating in or eligible but declined (i.e., nonparticipating) the active intervention study.The intervention-participating subjects were randomized into three groups, including two intervention groups (support and telephone groups) and a usual care reference group. Intervention-nonparticipating subjects were concurrently enrolled. Intervention effectiveness was assessed on the EQ-5D measure. The costs included direct healthcare cost from medical billing data, patient out-of-pocket expense, caregiver expense, patient loss-of-work cost, and intervention cost. We calculated incremental cost-effectiveness ratios (ICERs) from societal, provider, and patient perspectives.Two hundred and sixty-seven intervention-participating and 69 intervention-nonparticipating post-cancer treatment patients were included. The support and telephone groups, but not the usual care group, had significantly higher EQ-5D index scores (0.054, p = 0.033, and 0.057, p = 0.026, respectively) than the intervention-nonparticipating group at month 6. Within 6 months, intervention cost per subject was $252 and $484, respectively, for providers, and $564 and $203, respectively, for the support and phone group subjects. The final ICERs were $16,759 per quality-adjusted life year (QALY) and $12,561/QALY for support and telephone groups, compared with those of the intervention-nonparticipating group. These ICERs are much smaller than $50,000/QALY, the consensus threshold to determine cost-effectiveness for society.The study interventions are cost-effective in consideration of eligible patients who declined the interventions. The interventions can provide meaningful outcome improvement on urinary continence at a low cost. This evidence provides critical information for future health policy decision-making of healthcare providers and payers.

Project description:BackgroundApp-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use.ObjectiveThe goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure.MethodsWe used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment.ResultsFour interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms).ConclusionsThis study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app.International registered report identifier (irrid)RR2-10.1002/nau.23507.

Dataset Information

Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

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Mobile App for Treatment of Stress Urinary Incontinence: A Cost-Effectiveness Analysis.

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