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A clinical randomized controlled study of the recent effects of biofeedback electrical stimulation combined with gynecological radiofrequency therapy on postpartum pelvic floor functional rehabilitation

A clinical randomized controlled study of the recent effects of biofeedback electrical stimulation combined with gynecological radiofrequency therapy on postpartum pelvic floor functional rehabilitation - A randomized controlled study on BES combined with RF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090436
Enrollment
Unknown
Registered
2024-09-30
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-10-07

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

Conditions

Female pelvic floor dysfunction

Interventions

Test group A:Combined therapy of biofeedback electrical stimulation and gynecological radiofrequency
Test group B:radiofrequency treatment in gynecology
Control group C:Biofeedback electrical stimulation therapy

Sponsors

Banan Hospital Affiliated to Chongqing Medical University (Banan District People's Hospital of Chongqing)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Maternal women with a gestational age of greater than or equal to 35 weeks during delivery (2) subjects voluntarily joined the study and signed an informed consent form (3) began intervention treatment at 6-8 weeks postpartum and completed the treatment as required within 13 weeks postpartum (4) no cognitive impairment.

Exclusion criteria

Exclusion criteria: (1) patients with cardiac pacemaker; (2) patients with seizures; (3) patients with malignant tumors; (4) patients with severe arrhythmia; (5) patients with acute urogenital tract infection; (6) patients with other serious internal and surgical organic lesions; (7) patients with metal intrauterine devices after delivery.(8) The subject has mental and neurological disorders and cannot express his wishes correctly; the subject had a history of spinal cord injury, cerebral hemorrhage and cerebral infarction; the subject had undergone pelvic floor operation.

Design outcomes

Primary

MeasureTime frame
The POP-Q scores of the pelvic floor organs;Transverse vaginal diameter volume condition;Assessment of pelvic floor muscle modification;And Glazer surface EMG assessment of the pelvic floor muscle;Pelvic floor pain condition (VAS scoring score method);Pelvic floor ultrasound measures the fissure area of the levator anal muscle;

Countries

China

Contacts

Public ContactShaomin Zhang

Banan Hospital Affiliated to Chongqing Medical University (Banan District People's Hospital of Chongqing)

1516381392@qq.com+86 135 2751 0552

Outcome results

None listed

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