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Effect of FM® on Postpartum Stress Urinary Incontinence: A Clinical Randomized Controlled Trial

Effect of FM® on Postpartum Stress Urinary Incontinence

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107357
Enrollment
Unknown
Registered
2025-08-10
Start date
2025-08-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Stress Urinary Incontinence

Interventions

Intervention group:FM?
Control Group:Biofeedback stimulation

Sponsors

Gannan Medical University Third Affiliated Hospital(Affiliated Stomatological Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Clear lochia, 42 days to 12 months after vaginal delivery; 3. Patients who meet the diagnosis criteria for stress urinary incontinence (ICI-Q-SF score =6 points); 4. Patients without symptoms of difficultyinating such as frequent urination, urgent urination, painful urination; 5. Patients who know or sign the informed consent and voluntarily participate in the study

Exclusion criteria

Exclusion criteria: 1. Inability to accept pelvic floor myofascial physical therapy; 2. Severe SUI; 3. Pre-pregnancy SUI; 4. Previous pelvic surgery; 5. Pelvic malignant tumor; 6. Urinary and genital system infection; 7. Existence of cognitive behavioral disorders; 8. Inability to contract PFM

Design outcomes

Primary

MeasureTime frame
Surface electromyography of pelvic floor muscle;Frontal lobe blood oxygen changes;

Secondary

MeasureTime frame
Pelvic floor muscle strength;International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Score(ICIQ-UI SF);Urinary Incontinence Quality of Life Questionnaire(I-QoL);

Countries

China

Contacts

Public ContactHaoyuan Huang

Gannan Medical University Third Affiliated Hospital

17319180328@163.com+86 134 7999 7602

Outcome results

None listed

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