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Randomized Controlled Trial of Physical Energy-Based Therapy for Genitourinary Syndrome of Menopause in Women

Randomized Controlled Trial of Physical Energy-Based Therapy for Genitourinary Syndrome of Menopause in Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098205
Enrollment
Unknown
Registered
2025-03-04
Start date
2025-03-09
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Genitourinary Syndrome of Menopause

Interventions

Radiofrequency Group:AI-controlled Thermal Radiofrequency Therapy Device
Estriol Group:Estriol Cream
Blank control group:No intervention measures applied

Sponsors

West China Second Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (must meet all of the following criteria): 1.Voluntarily participate in the study and sign the informed consent form; 2.Female participants aged 45-60 years post-menopause; 3.Meet at least one of the following three indications: 1) Vaginal dryness, burning, and irritation symptoms; 2) Sexual symptoms such as lack of lubrication, discomfort or pain, or functional impairment; 3) Urinary symptoms such as urgency, dysuria, and recurrent chronic urinary tract infections, excluding acute urinary tract infections; or experience symptoms of stress urinary incontinence.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Pregnant women or those with recent fertility intentions; 2.History of photosensitivity; 3.Severe systemic medical conditions that affect daily life (e.g., severe cardiovascular diseases, immune system disorders); 4.Co-existing blood disorders, immune dysfunction, or oncological diseases; 5.History of gynecological surgery (e.g., mesh implantation); 6.Abnormal findings from TCT, ultrasound, infection screening tests, or vaginal smear; 7.Patients with psychological or mental disorders such as depression, who are unable to complete follow-up; 8.Severe hormone-related diseases or those at high risk for breast cancer or endometrial cancer; 9.Participants with known contraindications to estrogen therapy. (Note: Only patients who answer "No" to all of the above items will be eligible for inclusion.)

Design outcomes

Primary

MeasureTime frame
CVFSFI,Chinese version of the female sexual function scale;Vaginal resting pressure and maximum contraction pressure;Pad test;

Secondary

MeasureTime frame
Urinary Incontinence Questionnaire (Short Form);

Countries

China

Contacts

Public ContactWei Dongmei

West China Second University Hospital, Sichuan University

weidongmei@scu.edu.cn+86 189 8215 0655

Outcome results

None listed

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