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Efficacy and Mechanism of Sequential vs. Combined Magnetic-Electrical Therapy for Postpartum Pelvic Floor Dysfunction: A Randomized Controlled Trial with Dynamic Monitoring of Osteopontin Levels

Efficacy and Mechanism of Sequential vs. Combined Magnetic-Electrical Therapy for Postpartum Pelvic Floor Dysfunction: A Randomized Controlled Trial with Dynamic Monitoring of Osteopontin Levels

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118006
Enrollment
Unknown
Registered
2026-01-30
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Postpartum Pelvic Floor Dysfunction

Interventions

Sequential Magnetic-Electrical Therapy Group:Completed 10 sessions each of magnetic stimulation and electrical stimulation in three phases (magnetic ? magnetic-electric transition ? electrical)
Combined Magnetic-Electrical Therapy Group:Received simultaneous magnetic and electrical stimulation during each session, completing 10 sessions of each
Electrical Therapy Only Group:Electrical stimulation therapy administered exclusively, totaling 10 sessions

Sponsors

Shulan (Hangzhou) Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Primiparous or multiparous women aged 20–40 years who delivered vaginally, between 42 days postpartum and 3 months postpartum, with singleton full-term delivery (>=37 weeks); 2.At least one of the following diagnostic criteria for pelvic floor dysfunction is present: (1)Maximum contraction potential 20cm² or bladder neck mobility >25mm; (3) Urinary incontinence (ICI-Q-SF score>=1 point); 3.Informed Consent: Voluntarily sign the informed consent form and complete the follow-up plan.

Exclusion criteria

Exclusion criteria: 1.Pregnancy-related contraindications: Multiple pregnancies, history of forceps delivery, third- or fourth-degree perineal lacerations; 2.Systemic diseases: Severe cardiac, hepatic, or renal disease; diabetes mellitus; neurological disorders; 3.Therapeutic contraindications: History of pelvic floor surgery; presence of metallic implants or cardiac pacemakers; 4.Interfering factors: Use of estrogen-based medications within the past three months; participation in other pelvic floor rehabilitation programs.

Design outcomes

Primary

MeasureTime frame
Pelvic Floor Ultrasound (Cystocervical mobility, area of the genital hiatus, posterior bladder-urethral angle, urethral rotation angle);Pelvic Floor Electromyographic Parameters (Pre-resting potential, post-resting potential, maximum contraction potential of fast-twitch fibers, endurance potential of slow-twitch fibers);Serum osteopontin (OPN), Matrix metalloproteinase-2 (MMP-2);

Secondary

MeasureTime frame
Vaginal laxity questionnaire (VLQ), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI);Cost-effectiveness ratio(CER);

Countries

China

Contacts

Public ContactYan Guanghan

Shulan (Hangzhou) Hospital

guanghan.yan@shulan.com+86 13645813233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026