Three-Dimensional Breathing Patterns in Postpartum Stress Urinary Incontinence (PPSUI)

Jie Li

Status: Not yet enrolling

Conditions: Stress Urinary Incontinence (SUI)

Treatments: Behavioral: Three-dimensional breathing training; Behavioral: control group：Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT06623617

JieLi

Details and patient eligibility

About

**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.

Full description

User Experience Quality Control

1. Establish a dedicated technical team for system testing and quality control to ensure stable operation of the APP and accurate data.
2. Regularly update and optimize the virtual characters to guarantee the best user experience.

Data Security and Privacy Protection

1. Ensure that all user data is encrypted to protect user privacy and data security.
2. Comply with relevant regulations and standards to ensure the lawful use and protection of user data.

Enrollment: 210 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 20-35 years
2. Postpartum: 42 to 49 days
3. 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.

Exclusion criteria

1. BMI > 30 kg/m²
2. Cesarean section
3. Multiparous women
4. Pathological conditions or deformities of the spine
5. History of lumbopelvic surgery
6. Urogenital prolapse of grade 2 or higher
7. Professional athletes
8. Severe cardiopulmonary conditions during pregnancy or postpartum
9. Neurological diseases or cognitive impairments
10. Individuals unable to meet study requirements

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Intervention Group：three-dimensional breathing training group

Other group

Description:

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.

Treatment:

Behavioral: control group：Health education

Behavioral: Three-dimensional breathing training

Control group：Health education

Other group

Description:

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.

Treatment:

Behavioral: control group：Health education