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

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

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence (SUI)
• Intervention / Treatment: Behavioral: control group; Behavioral: Breathing training

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)

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie First Name: （jie） Middle initial: （） Degree: （Ph.D. candidate）; Phone Number: +86 151 1290 8469; Email: 1306172678@qq.com

Study Locations

• China
  • Shenzhen
    • Guangzhou, Shenzhen, China
      • Recruiting
      • Shenzhen Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: ≥18years
2. 6 weeks to 6 months postpartum
3. Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist

Exclusion Criteria:

1. Diabetes mellitus
2. Body mass index (BMI) >30 kg/m²
3. Cardiopulmonary or renal dysfunction
4. Neurological disorders
5. Pelvic organ prolapse exceeding stage II
6. History of lumbopelvic surgery
7. Lumbopelvic pain
8. Concurrent treatments that may interfere with study outcomes
9. Professional athletes
10. Current pregnancy

Withdrawal Criteria:

1. Failure to complete follow-up assessments
2. Loss of contact with participants

Termination Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 individual patient conditions.	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 individual patient conditions.
Experimental: Intervention Group：Breathing training group; All participants will receive standard postpartum care and recovery guidance, including routine examinations, health counseling, basic postpartum 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.	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 individual patient conditions.; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before and after 6 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before and after 6 weeks of intervention
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.	Before and after 6 weeks of intervention
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)	Before and after 6 weeks of intervention
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.	Before and after 6 weeks of intervention
Diaphragmatic Excursion During Deep Breathing and Coughing	Assessment was performed using the SonoScape S30 ultrasound imaging system. A curvilinear transducer C353 (SonoScape, China) with 3.0-5.0 MHz frequency was employed in M-mode to evaluate diaphragmatic movement. The transducer was positioned between the right midclavicular and anterior axillary lines, oriented medially, superiorly, and posteriorly to visualize the posterior third of the right hemidiaphragm. In M-mode imaging, the diaphragm appeared as a hyperechoic line moving freely during respiratory cycles. The upward excursion during inspiration was recorded, with the range of motion measured vertically from baseline to peak. Measurements were obtained during three conditions: Resting state (normal breathing)、Deep inspiration、Coughing	Before and after 6 weeks of intervention
Pelvic Floor Muscle (PFM) Displacement During Deep Expiration and Coughing	PFM displacement was evaluated using the SonoScape S30 ultrasound imaging system. In B-mode, a C353 curvilinear transducer (SonoScape, China) operating at 3.5-4.7 MHz frequency was employed to assess bladder base displacement. The transducer was positioned transversely along the midline of the suprapubic region. As the urethra, bladder neck, and bladder are anatomically related to the pelvic floor, any bladder base displacement directly reflects PFM activity. The assessment protocol included: Resting state: A reference marker ("X") was placed at the position of maximum PFM displacement during contraction Functional tasks: Participants performed deep expiration and coughing maneuvers Image capture: Maximum displacement points during tasks were marked as subsequent "X" points PFM activity was quantified by measuring the distance (in centimeters) between the resting "X" point and each task-induced "X" point, representing bladder base displacement.	Before and after 6 weeks of intervention

Collaborators and Investigators

• Sponsor: Jie Li
• Investigators: Study Chair: Wenzhi First Name: （Wenzhi） Middle initial: （） Degree: （Professor）, Shenzhen Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breathing training; Postpartum Stress Urinary Incontinence
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Control Groups; Breathing Exercises
• Other Study ID Numbers: JieLi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No