Treatment of Stress Urinary Incontinence via a Smartphone Application. Report from an Ongoing Randomised Controlled Study.
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Abstract
Background: Female urinary incontinence is common and affects up to one fourth of adult women. It may reduce quality of life and costs for society are high. The most common type is stress urinary incontinence (SUI), i.e. the leakage of urine on coughing, sneezing or jumping. The recommended first line treatment is pelvic floor muscle training (PFMT). Although SUI is common many women do not seek care. Reasons for this might be embarrassment or low access to care. There is a need for new, flexible and easily accessible treatment programmes for female urinary incontinence. The selling of smartphones is increasing rapidly. In 2013, 63% of Swedish adults owned a smartphone and 83% of them used mobile applications daily. Mobile applications provide new possibilities to deliver health care. In a previous study we have evaluated two treatment programmes for SUI based on PFMT, one Internet-based and one sent by post. Overall, 69,8% reported complete lack of leakage or reduced their number of leakage episodes after treatment. Using our experiences from the Internet-based programme we have now developed a treatment programme for SUI delivered as a smartphone application.
Objective: The purpose of this study is to determine if treatment of SUI via a smartphone application is effective.
Methods: Women with at least weekly SUI and age ≥18 years are recruited through our website. The diagnosis of SUI is based on validated questionnaires and a self-assessed maximum voiding volume of ≥ 0,3 litres. Eligible women are randomised to either the smartphone group where they receive the smartphone application (iPhone or android) immediately or to a group receiving the application after a three month follow-up. The application contains information about SUI, PFMT exercises (6 basic and 6 advanced levels) and functions for statistics and reminders. The three month follow-up includes a web-based questionnaire and a leakage diary. Primary outcome measures will be symptom severity measured with The International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) and condition-specific quality of life measured with The International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). Secondary outcomes will be Patient Global Impression of Improvement (PGI-I), change in Incontinence Episode Frequency (IEF), change in usage of incontinence aids and patient satisfaction. There is no face-to-face contact with the participants during the study. We aim to recruit 120 women. In the power calculation we assume that improvement in the smartphone group will be similar to the improvement in our previous Internet-based study. We also assume that the postponed treatment group will improve to some extent. The study is registered on Clinical Trials id. Nr. NCT01848938.
Results: Recruitement closed in June. Follow-up will be ready during the autumn. The study protocol and some inclusion data will be presented in detail at the conference.
Conclusions: Self-assessment and self-management of female SUI is possible. This study will evaluate if treatment via a smartphone application is effective.
Objective: The purpose of this study is to determine if treatment of SUI via a smartphone application is effective.
Methods: Women with at least weekly SUI and age ≥18 years are recruited through our website. The diagnosis of SUI is based on validated questionnaires and a self-assessed maximum voiding volume of ≥ 0,3 litres. Eligible women are randomised to either the smartphone group where they receive the smartphone application (iPhone or android) immediately or to a group receiving the application after a three month follow-up. The application contains information about SUI, PFMT exercises (6 basic and 6 advanced levels) and functions for statistics and reminders. The three month follow-up includes a web-based questionnaire and a leakage diary. Primary outcome measures will be symptom severity measured with The International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) and condition-specific quality of life measured with The International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). Secondary outcomes will be Patient Global Impression of Improvement (PGI-I), change in Incontinence Episode Frequency (IEF), change in usage of incontinence aids and patient satisfaction. There is no face-to-face contact with the participants during the study. We aim to recruit 120 women. In the power calculation we assume that improvement in the smartphone group will be similar to the improvement in our previous Internet-based study. We also assume that the postponed treatment group will improve to some extent. The study is registered on Clinical Trials id. Nr. NCT01848938.
Results: Recruitement closed in June. Follow-up will be ready during the autumn. The study protocol and some inclusion data will be presented in detail at the conference.
Conclusions: Self-assessment and self-management of female SUI is possible. This study will evaluate if treatment via a smartphone application is effective.
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