Stress Urinary Incontinence (SUI)PPSUINCT06623617
The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial
A study testing Breathing training in people with Stress Urinary Incontinence (SUI), run by Jie Li at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Breathing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18years
- 6 weeks to 6 months postpartum
- Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jie First Name: (jie) Middle initial: () Degree: (Ph.D. candidate) contact
China1 site, 1 recruiting
- Recruiting
Shenzhen Hospital of Southern Medical University
Guangzhou, Shenzhen
About this study
Official title: 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:
Read more
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.
Read the detailed description
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)
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Breathing training, control group
- Keywords
- Postpartum Stress Urinary Incontinence, Breathing training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing trainingBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 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. Receives: Behavioral: control group |
| Intervention Group:Breathing training group | Experimental | 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. Receives: Behavioral: Breathing training; Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and after 6 weeks of intervention
Secondary outcomes (6)
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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: Before and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Li, Shenzhen Hospital of Southern Medical University
- Investigators
- Wenzhi First Name: (Wenzhi) Middle initial: () Degree: (Professor), Study chair, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623617
- Sponsor's protocol ID
- JieLi
- Acronym
- PPSUI
- Status last verified
- Apr 2025
- First submitted
- 28 Sep 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Training on Postpartum Stress Urinary Incontinence : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06623617
- Acronym / sponsor ID
- PPSUI / JieLi
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Postpartum Stress Urinary Incontinence, Breathing training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Jie LiUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Behavioral: control groupAll 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. |
| Intervention Group:Breathing training group | Experimental | Behavioral: Breathing training, Behavioral: control groupAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: ≥18years
- 6 weeks to 6 months postpartum
- Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist
Key exclusion criteria (19 listed)
- Diabetes mellitus
- Body mass index (BMI) >30 kg/m²
- Cardiopulmonary or renal dysfunction
- Neurological disorders
- Pelvic organ prolapse exceeding stage II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing trainingAll 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. | Behavioural | Intervention Group:Breathing training group |
| control groupAll 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. | Behavioural | Control group, Intervention Group:Breathing training group |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie First Name: (jie) Middle initial: () Degree: (Ph.D. candidate) contact
Wenzhi First Name: (Wenzhi) Middle initial: () Degree: (Professor) study chair
Shenzhen Hospital of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing training in people with Stress Urinary Incontinence (SUI), run by Jie Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie First Name: (jie) Middle initial: () Degree: (Ph.D. candidate) (+86 151 1290 8469, 1306172678@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of PPSUI (time frame: Before and after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.