Evaluation of a New Treatment Using Mobile Applications in the Treatment of Stress Urinary Incontinence in Women Outside the Peripartum - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acceptability of study with information from doctor, physiotherapist and patients
研究概览
简要总结
Stress urinary incontinence (SUI) is the most common form of urinary incontinence in women. It affects women in their quality of life : physical, social, sexual and psychological levels. International recommendations suggest conservative treatments as first-line by training the pelvic floor muscles with or without a biofeedback-type control system. The latter allows the patient to visualize her muscle activity while stimulating her motivation. The part of adherence and compliance is very important in this rehabilitation where the woman must provide a significant commitment to continue the exercises beyond the support of the physiotherapist. In this area, a new approach is emerging with the arrival of health applications on smartphones. However, these tools lack scientific validation. The objective of this mixed pilot study (randomized controlled study with a qualitative part) is to investigate a new treatment for middle-aged to advanced patients outside the period of peripartum suffering from SUI, through an application mobile with probe as home program in standard physiotherapist treatment.
详细描述
The quantitative component is composed of 2 arms and the intervention is during 3 months:
- Study group : half of the participants will have a home pelvic floor work program via a mobile application in addition to therapeutic follow-up by a physiotherapist.
- Control group: the other half will perform the home pelvic floor work program without application and will also have therapeutic follow-up by a physiotherapist.
The qualitative component will include individual and semi-structured interviews based on an interview guide with 4 women in the study group and 4 women in the other group after completion of their perineal rehabilitation program.
The protocol will be offered to patients who meet the inclusion criteria (see below). Participants will be randomized into one of the two groups using sealed opaque envelopes, the order of which will have been randomly generated by randomization software.
Recruitment of participants will be done with the help of partner doctors. They will be responsible for introducing them to the study and providing them with the necessary documentation (information and informed consent sheets, 9 physiotherapy sessions for the treatment of SUI and the list of physiotherapists from the ASPUG-PP adapted to the study). The physiotherapists included in this study are all specialized in pelvi-perineology and members of ASPUG-PP and trained in the study protocol. They will ensure running of the process by collecting information from the anamnesis and carrying out pre- and post-tests with the project team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Free randomization via a pre-established listing including a coding system (0-intervention group and 1-control group) will be set up. A set of 30 opaque envelopes including a coding will be drawn for each participant by a person other than the principal investigator.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with SUI diagnosed by a doctor
排除标准
- •Post-partum at least 1 year
- •pregnant women
- •mixt urinary incontinence
结局指标
主要结局
Acceptability of study with information from doctor, physiotherapist and patients
时间窗: 6 months
Number of patients with the eligibility criteria over the recruitment period , Number of patients contacting physiotherapists to participate in the study over the recruitment period - Number of patients signing informed consent, enrolled over the duration of the study. Number of dropouts, timing. For each participant: her follow-up with dates. The patient's satisfaction with the PGI-I (Patient Global Impression Improvement). This questionnaire will be completed at the post-test observance of design: it will be evaluated via a "logbook" distributed to the patient . In relation to feasibility, we will evaluate the following parameters: The number of participants who complete the diary - The number of participants who follow the study guidelines - The number of participants who complete the home program, how often, for how long The number of participants who agree to participate in interviews
次要结局
- Observance- logbook(3 months)
- IU symptom - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)- urinary calenda(3 months)
- Quality of life - DITROVIE(3 months)
- Pelvic floor muscle functionality - PERFECT(3 months)
- Adherence - Incontinence Treatment Motivation Questionnaire (ITMQ)(3 months)
研究者
Bertuit Jeanne
Professor Associated
University of Applied Sciences of Western Switzerland