Clinical trial NCT06623617: Three-Dimensional Breathing Patterns in Postpartum Stress Urinary Incontinence
Official title: A Study on the Three-Dimensional Breathing Patterns of Patients With Postpartum Stress Urinary Incontinence Based on Pelvic Diaphragm Dynamics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence (SUI)
Keywords: Three-Dimensional Breathing
Postpartum Stress Urinary Incontinence
elvic Diaphragm Dynamics
pelvic floor exercises
Lead sponsor: Shenzhen Hospital of Southern Medical University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 210
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: \*\*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.

Detailed 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.

Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: Effectiveness Rate of Treatment for PPSUI Patients
timeFrame: The measurement is conducted 8 weeks after the intervention.
Secondary outcomes:
measure: Pelvic Floor Muscle Strength
timeFrame: The measurement is conducted 8 weeks after the intervention.
measure: Pelvic Floor Ultrasound Assessment of the Anterior Compartment
timeFrame: The measurement is conducted 8 weeks after the intervention.
measure: Degree of Anterior and Middle Compartment Prolapse
timeFrame: The measurement is conducted 8 weeks after the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen Hospital of Southern Medical University
name: Wenzhi First Name: （Wenzhi） Middle initial: （） Degree: （Professor）
role: STUDY_CHAIR
References: