Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06623617

The Impact of Breathing Training on PPSUI: 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Hospital of Southern Medical University

Guangzhou, Shenzhen, China

Location status: Recruiting

About this study

Quality Control Measures:

  • Implement strict quality control procedures during study design, data collection, and data entry.
  • Rigorously screen participants according to inclusion/exclusion criteria, establish good rapport to gain trust and cooperation, and minimize loss to follow-up.
  • Provide both obstetric clinic and researcher contact numbers, ensuring accuracy to prevent participant call rejection.
  • Trained professionals will administer questionnaires with on-site verification, clarifying questionable responses; questionnaires with >20% missing data will be excluded from analysis.
  • Adopt dual-entry verification for data input, with a third reviewer resolving discrepancies to ensure accuracy.
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breathing training

Behavioral

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.

Control Group

Behavioral

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.

Primary outcomes

  1. Severity of PPSUI

    Time frame: Before and after 6 weeks of intervention

    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

Secondary outcomes

  1. Pelvic Floor Muscle Strength

    Time frame: Before and after 6 weeks of intervention

    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

  2. Pelvic Floor Surface Electromyography

    Time frame: Before and after 6 weeks of intervention

    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.

  3. Transversus Abdominis (TrA) Contraction Rate

    Time frame: Before and after 6 weeks of intervention

    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)

  4. Maximum Voluntary Contraction (MVC) of Pelvic Floor Muscles

    Time frame: Before and after 6 weeks of intervention

    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.

  5. Diaphragmatic Excursion During Deep Breathing and Coughing

    Time frame: Before and after 6 weeks of intervention

    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

  6. Pelvic Floor Muscle (PFM) Displacement During Deep Expiration and Coughing

    Time frame: Before and after 6 weeks of intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie First Name: (jie) Middle initial: () Degree: (Ph.D. candidate)

CONTACT

[email protected]

+86 151 1290 8469

Sponsors and collaborators

Lead sponsor

Jie Li

Other

Registry information

Official study title

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

Acronym: PPSUI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.