NCT06623617 The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial
| NCT ID | NCT06623617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jie Li |
| Condition | Stress Urinary Incontinence (SUI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2025-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jie First Name: （jie） Middle initial: （） Degree: （Ph.D. candidate）
✉ 1306172678@qq.com📞 +86 151 1290 8469
Wenzhi First Name: （Wenzhi） Middle initial: （） Degree: （Professor）
STUDY CHAIR
Shenzhen Hospital of Southern Medical University
Frequently Asked Questions
Who can join the NCT06623617 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Stress Urinary Incontinence (SUI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06623617 currently recruiting?
Yes, NCT06623617 is actively recruiting participants. Contact the research team at 1306172678@qq.com for enrollment information.
Where is the NCT06623617 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06623617 clinical trial?
NCT06623617 is sponsored by Jie Li. The principal investigator is Wenzhi First Name: （Wenzhi） Middle initial: （） Degree: （Professor） at Shenzhen Hospital of Southern Medical University. The trial plans to enroll 58 participants.