Three-Dimensional Breathing Patterns in Postpartum Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence (SUI)
- Registration Number
- NCT06623617
- Lead Sponsor
- Jie Li
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 210
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effectiveness Rate of Treatment for PPSUI Patients 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.
- Secondary Outcome Measures
Name Time Method Pelvic Floor Muscle Strength The measurement is conducted 8 weeks after the intervention. Pelvic Floor Muscle Strength: Assessed using the modified Oxford grading system.
0 level (no muscle activity),
1. level (only muscle tremors or pulsations),
2. level (muscle strength can be felt but there is no lifting or squeezing sensation),
3. level (muscle strength is greater than level 2, lifting sensation can be felt; at this point, muscle contraction can be observed visually, and when 3 levels or above are detected, the examiner presses the posterior vaginal wall with their finger to provide resistance),
4. level (muscle strength is increased and contractions are good, capable of lifting the posterior vaginal wall against resistance),
5. level (capable of lifting the posterior vaginal wall against resistance, with the therapist\'s index and middle fingers being pinched together and pinched together and pulled towards the vagina).Pelvic Floor Ultrasound Assessment of the Anterior Compartment The measurement is conducted 8 weeks after the intervention. he ultrasonic diagnostic criterion for cystocele is when the lowest point of the bladder reaches the level of or below the reference line during maximum Valsalva maneuver. Further distinction of cystocele subtypes is made according to the Green classification criteria: Type I: Posterior vesicourethral angle ≥ 140°, urethral rotation angle \< 45°; Type II: Posterior vesicourethral angle ≥ 140°, urethral rotation angle ≥ 45°; Type III: Posterior vesicourethral angle \< 140°, urethral rotation angle ≥ 45°.
Degree of Anterior and Middle Compartment Prolapse The measurement is conducted 8 weeks after the intervention. Using the Pelvic Organ Prolapse Quantification (POP-Q) system, the degree of pelvic prolapse is assessed by measuring the distances between indicator points on the anterior wall, posterior wall, and apex of the vagina \[two points on the anterior wall (Aa, Ba), two points on the posterior wall (Ap, Bp), and two points on the apex (C, D)\] and the hymenal plane. Additionally, the genital hiatus, perineal body, and vaginal length are recorded to reflect the pelvic prolapse condition. In this study, we focused on the anterior compartment values that are more relevant to PPSUI (Pelvic Organ Prolapse Surgical Site Infection). Measurements were taken at the initial visit and at the end of treatment. Specifically, patients were positioned in the lithotomy position and instructed to perform a Valsalva maneuver to measure anterior vaginal wall prolapse (if a Valsalva maneuver could not be elicited at the initial visit, the assessment was conducted after initial treatment).