scholarly journals An app for self-management of urgency and mixed urinary incontinence in women: results from a randomised controlled trial (Preprint)

Author(s):  
Towe Wadensten ◽  
Emma Nyström ◽  
Karin Franzén ◽  
Anna Lindam ◽  
Elisabet Wasteson ◽  
...  
2020 ◽  
Author(s):  
Towe Wadensten ◽  
Emma Nyström ◽  
Karin Franzén ◽  
Anna Lindam ◽  
Elisabet Wasteson ◽  
...  

BACKGROUND Many women experience urgency and mixed urinary incontinence, but commonly hesitate to seek care. Treatment access and self-management can be supported through eHealth methods. OBJECTIVE This study investigated the efficacy of a mobile app for self-management of urgency and mixed urinary incontinence. METHODS This randomised controlled trial was conducted in Sweden. We included women of ≥18 year old, with urgency or mixed urinary incontinence and ≥2 leakages/week, excluding those with alarm symptoms. The women were recruited via information on TV, radio, and newspapers, and via Facebook advertisements. Initial selection was performed using a web-based screening questionnaire at our webpage. Data was then collected using an inclusion questionnaire and a two-day bladder diary. Symptom diagnosis was confirmed through a telephone interview. Participants were randomised to a treatment app (pelvic floor muscle training, bladder training, psychology, lifestyle advice, individual advice, statistics, reinforcement messages, and reminders) or brief information app (control). No guidance on the treatment was provided outside of the apps. The primary outcome was incontinence symptoms at follow-up (15 weeks), measured by ICIQ-UI SF score. Urgency symptoms were assessed via ICIQ-OAB score, and quality of life via ICIQ-LUTSqol score. Improvement was measured using Patient’s Global Impression of Improvement (PGI-I). These outcomes were patient reported. Cure was defined as no leakages (based on bladder diary). Intention-to-treat analysis was performed. RESULTS Between April 2017 and March 2018, 123 women were randomised to treatment (n=60, two lost to follow-up) or information (n=63). Of the included women, 28% had symptoms of urgency urinary incontinence, and 72% had mixed urinary incontinence. The mean age was 58.3 (SD 9.6) years and the majority had a university education. Half of the women were overweight or obese. Baseline characteristics did not differ between the two groups. The mean follow-up ICIQ-UI SF score was lower in the treatment group than the information group (estimated difference 3.1; 95% CI −4.8 to −1.3). For the follow-up ICIQ-OAB score, the estimated between-groups difference was −1∙8 (95% CI −2∙8 to −0∙99) and for the ICIQ-LUTSqol, the estimated between-groups difference was -6.3 (95% CI -10.5 to -2.1). Of women in the treatment group 90% reported an improvement, compared to 30% in the information group. Cure was reported by 19 women in the treatment group, and 4 in the control group (OR 5.38, 95% CI 1.86 to 15.57, p=0.002). During the 15-week treatment period, 69% of women in the treatment group used the app daily, and 10% used it at least three times per day. CONCLUSIONS The tested treatment app was effective for improvement and cure of urgency and mixed incontinence in women. It may be a good alternative to pharmacological treatment or other conservative management, increasing access to care. CLINICALTRIAL ClinicalTrials.gov NCT03097549


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e038452
Author(s):  
Yuanjie Sun ◽  
Yan Liu ◽  
Huan Chen ◽  
Yan Yan ◽  
Zhishun Liu

IntroductionEvidence specific for stress-predominant mixed urinary incontinence is still lacking at present, and acupuncture may relieve the symptoms. We plan to conduct this multi-centre, three-armed, randomised controlled trial to investigate the efficacy and safety of electroacupuncture among women with stress-predominant mixed urinary incontinence.Methods and analysisThe trial will be conducted at five hospitals in China. Two hundred thirty-two eligible women will be randomly assigned (2:1:1) to the electroacupuncture, sham electroacupuncture or waiting-list group to receive either 24-session acupuncture/sham acupuncture treatment over 8 weeks and 24-week follow-up or 20-week watchful waiting. The primary outcome is the proportion of participants with at least 50% reduction in mean 24-hour stress incontinence episode frequencies from baseline to week 8. The outcome will be analysed with the intention to treatpopulation (defined as participants randomised) with a two-sided p value of less than 0.05 considered significant.Ethics and disseminationThe protocol has been approved by Guang’anmen Hospital Institutional Review Board (2019-241-KY). Detailed information of the trial will be informed to the participants, and written informed consent will be obtained from every participant. Results of the trial are expected to be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT04299932).


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e048350
Author(s):  
Monika Kastner ◽  
Julie Makarski ◽  
Leigh Hayden ◽  
Jemila S Hamid ◽  
Jayna Holroyd-Leduc ◽  
...  

IntroductionIn response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called ‘KeepWell’ that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases.Methods and analysisWe will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness–implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability.Ethics and disseminationEthics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting.Trial registration numberNCT04437238.


2019 ◽  
Vol 13 (2) ◽  
pp. 122-133 ◽  
Author(s):  
Estibaliz Gamboa Moreno ◽  
Maider Mateo-Abad ◽  
Lourdes Ochoa de Retana García ◽  
Kalliopi Vrotsou ◽  
Emma del Campo Pena ◽  
...  

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Bernadette Bartlam ◽  
Trishna Rathod ◽  
Gillian Rowlands ◽  
Joanne Protheroe

This article reports a mixed methods process evaluation of a pilot feasibility randomised controlled trial comparing a Lay Health Trainer (LHT) intervention and usual care for those with poorly controlled Type 2 Diabetes Melitus (T2DM). Set in a deprived area in the UK, this research explores patient and health care practitioner (HCP) views on whether a structured interview between a patient and a Lay Health Trainer (LHT), for the purpose of developing a tailored self-management plan for patients, is acceptable and likely to change health behaviours. In doing so, it considers the implications for a future, randomised controlled trial (RCT). Participants were patients, LHTs delivering the intervention, service managers, and practice nurses recruiting patients to the study. Patients were purposively sampled on their responses to a baseline survey, and semistructured interviews were conducted within an exploratory thematic analysis framework. Findings indicate that the intervention is acceptable to patients and HCPs. However, LHTs found it challenging to work with older patients with long-term and/or complex conditions. In order to address this, given an ageing population and concomitant increases in those with such health needs, LHT training should develop skills working with these populations. The design of any future RCT intervention should take account of this.


BMJ ◽  
2006 ◽  
Vol 334 (7583) ◽  
pp. 25 ◽  
Author(s):  
Christian T Brown ◽  
Tet Yap ◽  
David A Cromwell ◽  
Lorna Rixon ◽  
Liz Steed ◽  
...  

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