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The effectiveness of gynecological matrix radiofrequency rehabilitation for complex urinary incontinence and symptomatic mild to moderate pelvic organ prolapse: a nationwide multicenter prospective clinical cohort study

The effectiveness of gynecological matrix radiofrequency rehabilitation for complex urinary incontinence and symptomatic mild to moderate pelvic organ prolapse: a nationwide multicenter prospective clinical cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099242
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Pelvic Floor Dysfunction

Interventions

Sponsors

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 18-75 years old, knowledge of the study, voluntary participation in the study, and signing of informed consent form; 2. Patients with vaginal laxity (self perceived vaginal laxity, unsatisfactory sexual life); 3. Patients with complex urinary incontinence (according to the International Urinary Control Association diagnostic criteria, conservative treatment for urinary incontinence is ineffective for >= 3 months, such as pelvic floor muscle rehabilitation training), including: (1) Urgency urinary incontinence; (2) Mixed urinary incontinence mainly characterized by mild stress urinary incontinence; (3) Severe stress urinary incontinence with no surgical intention at present; (4) Patients with mild to moderate stress urinary incontinence after surgical treatment, but no intention of surgery at present; 4. Patients with symptomatic mild to moderate pelvic organ prolapse (POP) who have not undergone pelvic floor surgery in the past, including: (1) Patients with symptoms such as frequent urination, urgency to urinate, lower abdominal distension, and abnormal bowel movements, and with POP-Q<stage III; (2) Mild to moderate POP patients with ineffective or ineffective pelvic floor magnetic stimulation rehabilitation therapy (POP-Q<stage III, Kegel exercise, pelvic floor electrical stimulation or magnetic stimulation at least 10 times, muscle strength improvement of less than 1 level and Glazer single parameter score improvement of less than 10 points 3 months after treatment); (3)Patients with old partial or complete rupture of the levator ani muscle who have no intention of surgery.

Exclusion criteria

Exclusion criteria: 1. Combine psychiatric and neurogenic diseases diagnosed by specialized doctors; 2. Acute urinary and reproductive system infections, tuberculosis, bleeding, or reproductive tract abnormalities; 3. Internal medicine comorbidities such as severe hypertension, liver and kidney dysfunction, or important organ failure; 4. Combining gynecological malignant tumors, previous surgical treatment for cervical cancer, endometrial cancer, ovarian cancer, or pelvic radiation therapy history; 5. Severe pelvic organ prolapse (POP-Q >= stage III); 6. Pregnancy or planned pregnancy; 7. Abnormal uterine bleeding without clear diagnosis.

Design outcomes

Primary

MeasureTime frame
Pelvic floor electromyography;Pelvic floor muscle strength;Pelvic floor POP-Q score;Pelvic Floor Dysfunction Questionnaire, PFDI-20;Pelvic Floor Disorders Impact Brief Questionnaire, PFIQ-7;

Secondary

MeasureTime frame
Vaginal width;1-hour urine pad experiment;

Countries

China

Contacts

Public ContactMingfu Wu

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

mingfuwutj@163.com+86 137 2017 2196

Outcome results

None listed

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