The efficacy and safety of temperature-controlled radiofrequency for the treatment of vaginal laxity in Chinese postpartum wome

Not Applicable

Completed

• Conditions: Treatment of vaginal laxity in Chinese postpartum women; Urological and Genital Diseases

• Registration Number: ISRCTN35181035
• Lead Sponsor: Tsinghua University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-29
• Study Start: 2024-07-18
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Capable of understanding and voluntarily signing an informed consent form
2. Premenopausal women who are =18 years old
3. Have had at least one full-term vaginal delivery (>36 weeks of gestation) and are =12 months postpartum at the time of enrollment in this study
4. In the VLQ, the subject's self-perceived degree of vaginal laxity during intercourse is rated as very loose, loose, or somewhat loose, and the degree of vaginal laxity measured by the researcher's digital examination is rated as severe, moderate, or mild
5. Cervical cytology results are normal
6. Willing to engage in vaginal intercourse at least once a week (note: this does not apply to situations where the subject must abstain from vaginal intercourse for at least one week after each study treatment)
7. Maintained a monogamous, heterosexual relationship for at least 6 months before study screening
8. The subject has a reasonable expectation, is capable of understanding, and can comply with the study procedures and all scheduled visit times
9. Women of childbearing age agree to use contraception throughout the study period

Exclusion Criteria

1. Pregnancy, planning to become pregnant during the study period, or have given birth in the past 12 months
2. History of genital tract fistula, thin rectovaginal septum (approximately 1 cm or one finger width as assessed by the investigator), or history of fourth-degree perineal tear
3. Presence of an implanted cardiac pacemaker, any other implanted electromagnetic device, or metal implants (except dental implants)
4. Concomitant sexual dysfunction or vaginismus that affects sexual activity
5. Severe or progressive diseases who, in the investigator's judgment, pose a serious risk by participating in this clinical trial
6. Uncontrolled or unstable hypertension as determined by the investigator
7. Inflammation or unhealed wounds on the vulva and/or vagina
8. History of psychiatric conditions that, in the investigator's judgment, may affect study compliance and evaluation (e.g., depression, anxiety, bipolar disorder)
9. Underwent vaginal tightening surgery within the past 5 years, pelvic radiofrequency or laser treatment within the past year, or plans to receive such treatments during the study
10. Any other condition deemed unsuitable for enrollment by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in FSFI total scores is measured at baseline and at 12 weeks post-treatment for the intervention group, and at baseline and 12 weeks post-final sham treatment for the control group