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A randomized controlled trial of Fu's subcutaneous needling for moderate stress urinary incontinence in postpartum women

A randomized controlled trial of Fu's subcutaneous needling for moderate stress urinary incontinence in postpartum women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001143
Enrollment
Unknown
Registered
2025-06-09
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress urinary incontinence

Interventions

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 44 Years

Inclusion criteria

Inclusion criteria: 1: Diagnostic Criteria for Moderate Stress Urinary Incontinence.(1)Involuntary leakage of urine during sudden increases in intra-abdominal pressure (e.g., sneezing, coughing, laughing). (2)Positive stress provocation test and pad test . (3)Absence of urinary frequency or urgency symptoms. (4)Moderate severity: Leakage volume between 5g and 10g.experimental group 2: Individuals aged 20–44 years, with first-onset stress urinary incontinence occurring within 1 year postpartum. 3: Voluntarily participate in the study and sign the informed consent

Exclusion criteria

Exclusion criteria: 1: Other types of urinary incontinence, such as overflow incontinence, mixed incontinence, urge incontinence, etc. 2: History of surgical treatment for urinary incontinence or pelvic floor surgery.A history of stress urinary incontinence during pregnancy prior to delivery. 3: Receiving specialized SUI treatment within the past 2 months or ongoing use of medications affecting bladder function. 4: Comorbidities: urinary tract infection, urolithiasis, pelvic malignancies, vaginal bleeding, pelvic organ prolapse. 5: Inability or significant limitation in walking, climbing stairs, or running. 6: Severe systemic conditions: hepatic/renal dysfunction, cardiovascular/cerebrovascular diseases, diabetes mellitus, cauda equina syndrome, spinal cord lesions. 7: Severe low back pain or lumbar disc herniation. 8: Psychiatric disorders, severe needle phobia, or inability to cooperate with treatment. 9: Pregnancy.

Design outcomes

Primary

MeasureTime frame
1-hour urine pad test urine leakage;

Secondary

MeasureTime frame
Score of incontinence impact questionnaire short form;Severity of urinary incontinence;Score of Incontinence Questionnaire of the International Incontinence Advisory Committee;Use of other treatments;Number of urinary incontinence in 24 hours;Urodynamic testing;

Countries

China

Contacts

Public ContactHuafeng CUI

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

cuihuafeng@139.com15905319754

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026