The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial
ConditionStress Urinary Incontinence (SUI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJie Li
About this trial
\*\*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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥18years
6 weeks to 6 months postpartum
Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist
Disqualifiers
Diabetes mellitus
Body mass index (BMI) >30 kg/m²
Cardiopulmonary or renal dysfunction
Neurological disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Breathing training
BehavioralAll 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 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.
control group
BehavioralAll 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 individual patient conditions.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Intervention Group：Breathing training groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Severity of PPSUI
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), developed by the International Continence Society (ICS), serves as the standardized assessment tool. This 4-domain questionnaire evaluates: Frequency of urine leakage Volume of leakage Impact on daily life Timing of leakage Severity Grading (based on first 3 domains): Mild: Total score ≤7 Moderate: 7 \< score ≤14 Severe: 14 \< score ≤21
Time frame
Before and after 6 weeks of interventionSecondary outcomes
1
Pelvic Floor Muscle Strength
Pelvic floor muscle strength was assessed using the Modified Oxford Scale (MOS), a grading system originally developed by medical researchers at the University of Oxford to differentiate between varying levels of muscle strength. In this study, the MOS was employed to evaluate changes in pelvic floor muscle strength before and after treatment, and to guide decisions regarding the application of resistance during therapy. The standardized assessment procedure required patients to empty their bladder and assume the lithotomy position while relaxing their abdominal, gluteal, and thigh muscles. Following proper perineal disinfection and while wearing sterile gloves, the therapist inserted the index and middle fingers 4-6 cm into the vagina to palpate at the 5 and 7 o'clock positions. Patients were then instructed to perform maximal voluntary contractions of their pelvic floor muscles, with the therapist evaluating the muscle activity according to MOS criteria. All assessment data were sys
Time frame
Before and after 6 weeks of intervention2
Pelvic Floor Surface Electromyography
Pelvic floor muscle electrical activity was evaluated using the Glazer Protocol for Pelvic Floor Surface Electromyography. A vaginal electrode was inserted to collect sEMG signals while participants performed guided contraction and relaxation exercises. Participants maintained a 120-degree angle between their upper body and lower limbs, with legs extended naturally, feet externally rotated, and full-body relaxation to minimize engagement of abdominal, gluteal, and thigh adductor muscles.
Time frame
Before and after 6 weeks of intervention3
Transversus Abdominis (TrA) Contraction Rate
The contraction rate of the TrA muscle was evaluated using the SonoScape S30 ultrasound imaging system in B-mode. Contraction Rate = (Contracted Thickness) / (Resting Thickness)
Time frame
Before and after 6 weeks of intervention4
Maximum Voluntary Contraction (MVC) of Pelvic Floor Muscles
The MVC was assessed by an experienced pelvic floor rehabilitation therapist using the Glazer Protocol for Pelvic Floor Surface Electromyography. Developed by pelvic floor muscle expert Dr. Howard Glazer, this gold-standard evaluation employs surface electromyography (sEMG) technology to record the electrical activity of pelvic floor muscles. The assessment provides comprehensive data on muscle activation speed, variability, and amplitude, enabling evaluation of overall relaxation/contraction function and monitoring rehabilitation progress. For this study, measurements were conducted using the Malod MLD B4Splus biofeedback stimulator, which precisely captures and analyzes sEMG signals during maximal voluntary contractions.
Time frame
Before and after 6 weeks of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jie Li
Lead sponsor
Shenzhen Hospital of Southern Medical University
Sponsor institution
Source ClinicalTrials.gov