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

NCT06623617 | Recruiting

• 1 other identifier: JieLi
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Postpartum Stress Urinary Incontinence; Breathing training

Outcome Measures

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

  Before and after 6 weeks of intervention

Secondary Outcomes (6)

• Pelvic Floor Muscle Strength

  Before and after 6 weeks of intervention

• Pelvic Floor Surface Electromyography

  Before and after 6 weeks of intervention

• Transversus Abdominis (TrA) Contraction Rate

  Before and after 6 weeks of intervention

• Maximum Voluntary Contraction (MVC) of Pelvic Floor Muscles

  Before and after 6 weeks of intervention

• Diaphragmatic Excursion During Deep Breathing and Coughing

  Before and after 6 weeks of intervention

Study Arms (2)

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.

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.

Behavioral: Breathing training; Behavioral: control group

Interventions

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.

Intervention Group：Breathing training group

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.

Control group; Intervention Group：Breathing training group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jie Li: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Guangzhou, Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Breathing Exercises; Control Groups

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Wenzhi First Name: （Wenzhi） Middle initial: （） Degree: （Professor）

  Shenzhen Hospital of Southern Medical University

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+86 151 1290 8469; 1306172678@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 2, 2024
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)