Implementation of the App Tät®II for Treatment of Urgency and Mixed Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Is treatment via Tät®II effective and feasible after contact with the primary care?
研究概览
简要总结
This observational study aims to evaluate the implementation and use of the Tät®II app for the treatment of urgency and mixed urinary incontinence in women over the age of 18 after contact with ordinary healthcare, as well as its effectiveness. The study aims to answer the following question:
Is treatment via the app effective and feasible after primary care?
Participants will use the app for 15 weeks to treat urgency and mixed urinary incontinence. They will answer online survey questions about their urinary incontinence before, after 15 weeks, and one year after treatment.
详细描述
The implementation study includes women diagnosed with urgency or mixed urinary incontinence by their doctor and recommended first-line treatment with pelvic floor muscle training and/or bladder training.
We plan to recruit eligible participants by advertising in primary care center waiting rooms, on social media, and on our research webpage. Primary care doctors and nurses will also receive information about the study. Women interested in the study from all over Sweden can visit our webpage (tät.nu) for more information. The webpage will include detailed information about the study, the informed consent procedure, an informed consent form, a screening questionnaire, and contact details for the research group.
Women interested in participating in the study are asked to read the subject information and answer the screening questionnaire describing the inclusion and exclusion criteria. Those who are eligible will be asked to send their email address to the research group, which will then contact them by email to schedule a secure video meeting.
During the digital meeting, the investigators will provide additional information about the study and answer any questions. The investigator will also verify that the woman meets all the inclusion criteria and none of the exclusion criteria.
To certify that she has received a medical evaluation for her urinary incontinence, she must send the research team a copy of a medical record. The assessment must not be older than six months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age ≥18 years
- •Symptoms of urgency urinary incontinence or mixed urinary incontinence
- •Medical evaluation and documentation of urinary incontinence by ordinary doctor
- •Signed informed consent
排除标准
- •Pregnancy
- •Childbirth in the last 6 months
- •Painful urges
- •Difficulties emptying the bladder
- •Blood in urine
- •Need of further investigation concerning the urinary incontinence, according to the clinical doctor
结局指标
主要结局
Is treatment via Tät®II effective and feasible after contact with the primary care?
时间窗: From participants enrollment to the end of treatment at 15 weeks.
The primary outcome for the treatment effect is the validated and widely used ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) symptom score. The ICIQ-UI SF includes three questions about urinary incontinence: how often it occurs, how much leakage there is, and how bothersome it is. These questions form an additive score ranging from 0 to 21 points. The questionnaire also includes a fourth question that is not included in the total score, but that is used to categorize the type of leakage. Web-based questionnaires will be sent via email at the beginning of the study and again after 15 weeks. These questionnaires will include the validated ICIQ-UI SF symptom questionnaire. Primary endpoint: The mean difference in the ICIQ-UI SF score from baseline to the 15-week follow-up.
次要结局
- How does the quality of life (QoL) change after 15 weeks of treatment with the Tät®II app?(From enrollment to the end of treatment at 15 weeks.)
- Patient Global Impression of Improvement at 15-week follow up(From enrollment to the end of treatment at 15 weeks.)
