The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breathing training, control group.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence (SUI). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Breathing Training on Postpartum Stress Urinary Incontinence : A Randomized Controlled Trial
Overview
\*\*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.
Detailed description
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)
Interventions
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Severity of PPSUI [Time frame: Before and after 6 weeks of intervention]
Secondary outcome measures (6)
- Pelvic Floor Muscle Strength [Time frame: Before and after 6 weeks of intervention]
- Pelvic Floor Surface Electromyography [Time frame: Before and after 6 weeks of intervention]
- Transversus Abdominis (TrA) Contraction Rate [Time frame: Before and after 6 weeks of intervention]
- Maximum Voluntary Contraction (MVC) of Pelvic Floor Muscles [Time frame: Before and after 6 weeks of intervention]
- Diaphragmatic Excursion During Deep Breathing and Coughing [Time frame: Before and after 6 weeks of intervention]
- Pelvic Floor Muscle (PFM) Displacement During Deep Expiration and Coughing [Time frame: Before and after 6 weeks of intervention]
Eligibility criteria
Inclusion criteria
- Age: ≥18years
- 6 weeks to 6 months postpartum
- Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Hospital of Southern Medical University — Guangzhou
Identifiers
NCT: NCT06623617 · JieLi