A Study on the Three-Dimensional Breathing Patterns of Patients With Postpartum Stress Urinary Incontinence Based on Pelvic Diaphragm Dynamics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- Effectiveness Rate of Treatment for PPSUI Patients
研究概览
简要总结
**Clinical Trial** The purpose of this clinical trial is to determine whether three-dimensional breathing training is effective in treating postpartum stress urinary incontinence (PPSUI). The main question it aims to answer is: Can three-dimensional breathing training improve or treat postpartum stress urinary incontinence?
Participants will:
- Receive one-on-one verbal health education covering the causes and risk factors of PPSUI, benefits and precautions of pelvic floor exercises and breathing, and implementation methods.
- Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
详细描述
User Experience Quality Control
- Establish a dedicated technical team for system testing and quality control to ensure stable operation of the APP and accurate data.
- Regularly update and optimize the virtual characters to guarantee the best user experience.
Data Security and Privacy Protection
- Ensure that all user data is encrypted to protect user privacy and data security.
- Comply with relevant regulations and standards to ensure the lawful use and protection of user data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20-35 years
- •Postpartum: 42 to 49 days
- •Diagnosed with pure postpartum stress urinary incontinence (PPSUI) by an experienced obstetrician/gynecologist during the first postpartum check-up, according to the International Continence Society (ICS) standards.
排除标准
- •BMI > 30 kg/m²
- •Cesarean section
- •Multiparous women
- •Pathological conditions or deformities of the spine
- •History of lumbopelvic surgery
- •Urogenital prolapse of grade 2 or higher
- •Professional athletes
- •Severe cardiopulmonary conditions during pregnancy or postpartum
- •Neurological diseases or cognitive impairments
- •Individuals unable to meet study requirements
研究组 & 干预措施
Intervention Group：three-dimensional breathing training group
Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
干预措施: Three-dimensional breathing training (Behavioral)
Intervention Group：three-dimensional breathing training group
Engage in app-based three-dimensional breathing training and learn to use a biofeedback pressure device at home for proper and effective training. They will also be guided to log their daily training, manually inputting data such as duration and frequency. A virtual assistant will provide real-time feedback based on this data, including encouragement and adjustments to training intensity.
干预措施: control group：Health education (Behavioral)
Control group：Health education
The control group received health education, which was conducted one-on-one by researchers during the recruitment of mothers. The content included the etiology and risk factors of PPSUI (Prolapse of Pelvic Organs during Straining), the benefits and precautions of pelvic floor muscle exercises and breathing, as well as the implementation methods.
干预措施: control group：Health education (Behavioral)
结局指标
主要结局
Effectiveness Rate of Treatment for PPSUI Patients
时间窗: The measurement is conducted 8 weeks after the intervention.
Criteria for Cure: Both no leakage on the ICIQ-SF assessment and a negative Stress Induced Test must be met. Criteria for Improvement: A reduction of ≥1 point in the frequency dimension score or a reduction of ≥2 points in the volume dimension score on the ICIQ-SF assessment after treatment. Criteria for Ineffectiveness: No change or an increase in the scores of both the frequency and volume dimensions of urine leakage on the ICIQ-SF assessment.
次要结局
- Pelvic Floor Muscle Strength(The measurement is conducted 8 weeks after the intervention.)
- Pelvic Floor Ultrasound Assessment of the Anterior Compartment(The measurement is conducted 8 weeks after the intervention.)
- Degree of Anterior and Middle Compartment Prolapse(The measurement is conducted 8 weeks after the intervention.)
研究者
Jie Li
Nurse
Shenzhen Hospital of Southern Medical University