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Self-management of stress urinary incontinence via a mobile app: two-year follow-up of a randomized controlled trial.

ABSTRACT: INTRODUCTION:We investigated the long-term effects of using a mobile app to treat stress urinary incontinence with a focus on pelvic floor muscle training. MATERIAL AND METHODS:A previous randomized controlled trial of 123 women aged 27-72 years found that three months of self-managing stress urinary incontinence with support from the Tät® app was effective. We followed up the women in the app group (n = 62) two years after the initial trial with the same primary outcomes for symptom severity (International Consultation on Incontinence Questionnaire Short Form) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptom Quality of Life) and compared the scores with those at baseline. RESULTS:Of the 62 women, 61 and 46 (75.4%), respectively, participated in three-month and two-year follow-ups. Baseline data did not differ between responders and non-responders at follow-up. The mean decreases in International Consultation on Incontinence Questionnaire Short Form and ICIQ-Lower Urinary Tract Symptom Quality of Life scores after two years were 3.1 (95% confidence interval 2.0-4.2) and 4.0 (95% confidence interval 2.1-5.9), respectively. Of the 46 women, four (8.7%) rated themselves as very much better, nine (19.6%) as much better, and 16 (34.8%) as a little better. The use of incontinence protection products decreased significantly (p = 0.04), and the proportion of women who felt they could contract their pelvic muscles correctly increased from 14/46 (30.4%) at baseline to 31/46 (67.4%) at follow-up (p < 0.001). CONCLUSIONS:Self-management of stress urinary incontinence with support from the Tät® app had significant and clinically relevant long-term effects and may serve as first-line treatment.

SUBMITTER: Hoffman V

PROVIDER: S-EPMC5638068 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Self-management of stress urinary incontinence via a mobile app: two-year follow-up of a randomized controlled trial.

Hoffman Victoria V Söderström Lars L Samuelsson Eva E

Acta obstetricia et gynecologica Scandinavica 20170821 10

<h4>Introduction</h4>We investigated the long-term effects of using a mobile app to treat stress urinary incontinence with a focus on pelvic floor muscle training.<h4>Material and methods</h4>A previous randomized controlled trial of 123 women aged 27-72 years found that three months of self-managing stress urinary incontinence with support from the Tät<sup>®</sup> app was effective. We followed up the women in the app group (n = 62) two years after the initial trial with the same primary outcom ...[more]

PMID: 28718223

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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:BackgroundMobile 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.ObjectiveThe objective of this study was to evaluate the health economy of the app for treating SUI.MethodsThis 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.ResultsThe 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.ConclusionsThe 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.

Project description:BackgroundDaytime urinary incontinence (UI) is common in childhood and often persists into adolescence. UI in adolescence is associated with a range of adverse outcomes, including depressive symptoms, peer victimization, poor self-image, and problems with peer relationships. The first-line conservative treatment for UI is bladder training (standard urotherapy) that aims to establish a regular fluid intake and a timed schedule for toilet visits. The success of bladder training is strongly dependent on good concordance, which can be challenging for young people.ObjectiveThis paper aims to describe the development of a smartphone app (URApp) that aims to improve concordance with bladder training in young people aged 11 to 19 years.MethodsURApp was designed by using participatory co-design methods and was guided by the person-based approach to intervention design. The core app functions were based on clinical guidance and included setting a daily drinking goal that records fluid intake and toilet visits, setting reminders to drink fluids and go to the toilet, and recording progress toward drinking goals. The development of URApp comprised the following four stages: a review of current smartphone apps for UI, participatory co-design workshops with young people with UI for gathering user requirements and developing wireframes, the development of a URApp prototype, and the user testing of the prototype through qualitative interviews with 23 young people with UI or urgency aged 10 to 19 years and 8 clinicians. The app functions and additional functionalities for supporting concordance and behavior change were iteratively optimized throughout the app development process.ResultsYoung people who tested URApp judged it to be a helpful way of supporting their concordance with a timed schedule for toilet visits and drinking. They reported high levels of acceptability and engagement. Preliminary findings indicated that some young people experienced improvements in their bladder symptoms, including a reduction in UI. Clinicians reported that URApp was clinically appropriate and aligned with the best practice guidelines for bladder training. URApp was deemed age appropriate, with all clinicians reporting that they would use it within their own clinics. Clinicians felt URApp would be of particular benefit to patients whose symptoms were not improving or those who were not engaging with their treatment plans.ConclusionsThe next stage is to evaluate URApp in a range of settings, including pediatric continence clinics, primary care, and schools. This research is needed to test whether URApp is an effective (and cost-effective) solution for improving concordance with bladder training, reducing bladder symptoms, and improving the quality of life.

Project description:ObjectivesTo evaluate long-term effects, complications and satisfaction among patients treated with AdVance™ and AdVance™ XP slings (AS) at a Norwegian specialist care hospital.Materials and methodsPatients who had an AS implanted due to stress urinary incontinence (SUI) 2009-2016 were identified retrospectively. Demographic and perioperative data were extracted from electronic patient files. We did a patient-reported outcome measure (PROM) survey with the Expanded Prostate Cancer Index Composite (EPIC-26) urinary domain and a Satisfaction Questionnaire (SQ) 2018-2020. Cure was defined as use of ≤1 pad/day.ResultsThe AS was implanted in 165 patients, mainly due to mild to moderate SUI (median leakage 112 g, range 13-589 g/24 h). Preoperative urodynamics showed mild detrusor overactivity (DO) in 11 patients. At 6-week follow-up, 148 patients (90%) were cured. The most common complication was urinary retention (N = 38), transient in 32 patients (range 1-42 days). Two patients were later operated with division of the sling due to persistent retention. During clinical follow-up of up to 12 years, 27 patients were reoperated due to persistent/recurrent incontinence. The PROM survey was sent to 125 patients and 115 (92%) replied at median 73 (20-134) months postoperatively. Ninety-one (79%) used ≤1 pads/day, 97 (85%) were satisfied, one patient-reported pain. Regression analyses showed that failure (>1 pad/day) was significantly associated with a higher amount of leakage preoperatively and at the 6-week follow-up. Total cure rate in the complete cohort was 64% at median 73 (20-134) months follow-up.ConclusionsThe AS shows good and persistent long-term results in patients with mild to moderate SUI. The only identified risk factor for long-term failure was higher amount of leakage preoperatively. The incidence of high body mass index (BMI), DO and previous radiotherapy was low and not significantly associated with failure but is still considered risk factors.

Project description:IntroductionFew prospective studies have revealed the long-term neuromuscular alterations of pelvic floor after vaginal delivery. The aim of this study was to evaluate the impact of episiotomy on the electrical activity of pelvic floor muscle 2 years following vaginal delivery, and explore the relation between surface electromyography (sEMG) amplitudes and urinary incontinence.Material and methodsA total of 427 primiparous women with full-term singleton vaginal delivery were included in the cohort and 362 with no further births within the 2 year follow-up completed observations. Of these, 200 underwent episiotomy and 162 underwent nonepisiotomy. Clinical demographic characteristics, vaginal EMG variables and urinary incontinence-specific questionnaire scores were collected at 6 weeks, 6, 12 and 24 months after childbirth, respectively. Primary outcomes were the comparison of sEMG values between the episiotomy and nonepisiotomy groups throughout 2 years. Secondary outcomes were the correlation between sEMG of both groups and the incidence and severity of urinary incontinence. Spearman's correlation analysis, Kruskal-Wallis test and ANOVA with Bonferroni correction were used to analyze the variables.ResultsAmplitude of maximal fast and endurance contractions on sEMG in the episiotomy group was significantly lower than the nonepisiotomy counterpart. Such difference of sEMG persisted for a long period after birth: endurance contraction, 33.12 ± 8.92 vs 35.085 ± 9.98, p < 0.01 at 24 months, and fast contraction, 36.53 ± 8.87 vs 39.05 ± 9.98, p = 0.01 at 12-month. Although there was no significant difference in incidence and severity of urinary incontinence between both groups, a negative correlation existed between EMG values of muscle contraction and urinary incontinence symptoms throughout.ConclusionsPrimiparous women delivered with episiotomy demonstrated lower contractile sEMG activity of pelvic floor muscle in the long term. The lower sEMG values of fast contraction were associated with urinary incontinence symptoms.

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.

Dataset Information

Self-management of stress urinary incontinence via a mobile app: two-year follow-up of a randomized controlled trial.

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Self-management of stress urinary incontinence via a mobile app: two-year follow-up of a randomized controlled trial.

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