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A Randomized Controlled Trial of Physical Energy-Based Therapy for Vaginal Relaxation Syndrome

A Randomized Controlled Trial of Physical Energy-Based Therapy for Vaginal Relaxation Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097812
Enrollment
Unknown
Registered
2025-02-26
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Vaginal Relaxation Syndrome

Interventions

Laser Sequential Radiofrequency Group:Laser Sequential Radiofrequency
Radiofrequency Sequential Laser Group:Radiofrequency Sequential Laser

Sponsors

West China Second Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent form; 2. Women aged 20-65 years old; 3. Have had at least 1 vaginal delivery experience, and the degree of laxity as self-rated by the Vaginal Relaxation Questionnaire (VLQ) does not exceed 3 points (i.e., "very lax", "moderately lax" or "slightly lax"); 4. The degree of vaginal laxity is mild and moderate to be diagnosed by digital examination; 5. Normal vaginal and pelvic examination, normal Pap smear/cervical smear test results in the past 1 year, and negative pregnancy test; 6. Have sex at least twice a month, and have no reproductive needs during the study period.

Exclusion criteria

Exclusion criteria: 1. There are implantable medical devices such as intrauterine devices and pacemakers; 2. Pelvic organ prolapse score (POP-Q) > 2; 3. Pregnant or lactating; 4. History of chronic vulvodynia; 5. Unexplained vaginal bleeding; 6. History of sexually transmitted diseases or pelvic inflammatory infection, immunosuppressive diseases; 7. Have undergone surgery or intervention for vaginal relaxation treatment; 8. Or other comorbid diseases or drug use that affect wound healing or sexual life; 9. History of diabetes or hypertension and skin disease.

Design outcomes

Primary

MeasureTime frame
Chinese Version of Female Sexual Function Index, CVFSFI;Vaginal laxity questionnaire (VLQ);Vaginal health index (VHI);

Secondary

MeasureTime frame
Sexual satisfaction questionnaire (SSQ);Overall Satisfaction;Electromyographic (EMG) value of the pelvic floor muscles ;Adverse events;

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