The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial

Официальное название

The Effect of Breathing Training on Postpartum Stress Urinary Incontinence : A Randomized Controlled Trial

Обзор

\*\*Clinical Trial\*\* This clinical trial aims to investigate the clinical therapeutic effects of breathing training on postpartum stress urinary incontinence (PPSUI). Participants will: All participants will receive standard postpartum care and recovery guidance, including routine examinations, health counseling, basic postpartum recovery recommendations, and educational information. Control Group: Participants will receive conventional pelvic floor rehabilitation therapy, which may include one or a combination of the following: magnetic stimulation therapy, electromyographic biofeedback therapy, and manual therapy. The specific treatment methods and frequency will be determined based on individual patient conditions. Intervention Group: In addition to the same pelvic floor rehabilitation therapy as the control group, participants will receive breathing training. Before each session, participants will empty their bladder. The breathing training will be conducted under researcher supervision and guidance, with each session lasting 20 minutes, administered once daily, three times per week for 6 weeks. Participants are encouraged to perform the training in the hospital under researcher supervision. Those unable to attend in-person sessions may conduct home-based training after mastering the technique and must report their training status to researchers afterward. Researchers will monitor weekly training completion and provide timely reminders to ensure adherence. If dizziness or difficulty breathing occurs during training, participants must immediately discontinue the session.

Подробное описание

Quality Control Measures:

1. Implement strict quality control procedures during study design, data collection, and data entry. 2. Rigorously screen participants according to inclusion/exclusion criteria, establish good rapport to gain trust and cooperation, and minimize loss to follow-up. 3. Provide both obstetric clinic and researcher contact numbers, ensuring accuracy to prevent participant call rejection. 4. Trained professionals will administer questionnaires with on-site verification, clarifying questionable responses; questionnaires with \>20% missing data will be excluded from analysis. 5. Adopt dual-entry verification for data input, with a third reviewer resolving discrepancies to ensure accuracy. 6. During analysis, strictly adhere to statistical method assumptions, consulting professional statisticians when necessary to guarantee methodological validity.

(Key features: 1) Passive voice for objectivity 2) Technical precision 3) Parallel structure 4) Compliance with research protocol standards)

Вмешательства

• Поведенческое Breathing training
  All participants will receive standard postpartum care and recovery guidance, including routine examinations, health counseling, basic postpartum r In addition to the same pelvic floor rehabilitation therapy as the control group, participants will receive breathing training. Before each session, participants will empty their bladder. The breathing training will be conducted under researcher supervision and guidance, with each session lasting 20 minutes, administered once daily, three times per w
• Поведенческое control group
  All participants will receive standard postpartum care and recovery guidance, including routine examinations, health counseling, basic postpartum recovery recommendations, and educational information. Participants will receive conventional pelvic floor rehabilitation therapy, which may include one or a combination of the following: magnetic stimulation therapy, electromyographic biofeedback therapy, and manual therapy. The specific treatment methods and frequency will be determined based on ind

Первичные конечные точки

• Severity of PPSUI [Срок оценки: Before and after 6 weeks of intervention]

Вторичные конечные точки (6)

• Pelvic Floor Muscle Strength [Срок оценки: Before and after 6 weeks of intervention]
• Pelvic Floor Surface Electromyography [Срок оценки: Before and after 6 weeks of intervention]
• Transversus Abdominis (TrA) Contraction Rate [Срок оценки: Before and after 6 weeks of intervention]
• Maximum Voluntary Contraction (MVC) of Pelvic Floor Muscles [Срок оценки: Before and after 6 weeks of intervention]
• Diaphragmatic Excursion During Deep Breathing and Coughing [Срок оценки: Before and after 6 weeks of intervention]
• Pelvic Floor Muscle (PFM) Displacement During Deep Expiration and Coughing [Срок оценки: Before and after 6 weeks of intervention]

Критерии участия

Критерии включения

• Age: ≥18years
• 6 weeks to 6 months postpartum
• Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist

Критерии исключения

• Diabetes mellitus
• Body mass index (BMI) >30 kg/m²
• Cardiopulmonary or renal dysfunction
• Neurological disorders
• Pelvic organ prolapse exceeding stage II
• History of lumbopelvic surgery
• Lumbopelvic pain
• Concurrent treatments that may interfere with study outcomes
• Professional athletes
• Current pregnancy

Withdrawal Criteria:

• Failure to complete follow-up assessments
• Loss of contact with participants

Termination Criteria:

• Immediate discontinuation if participants experience dizziness, chest tightness, palpitations, or dyspnea during training
• Inability to continue intervention due to health issues (e.g., severe complications)
• Pregnancy occurring during the intervention period
• Non-compliance with prescribed breathing exercises
• Participant-initiated withdrawal from the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shenzhen Hospital of Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06623617 · JieLi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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